Drugs / Ruxolitinib
Ruxolitinib
also known as
Rux · ruxolitinib phosphate · Jakavi · INC424 · Jakafi · INCB018424 · INCB018424 phosphate cream · INCB018242 · +9 more
Small molecule targets JAK1, JAK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 24 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acquired polycythemia vera 1 milestone | |||||
| Filed | US (FDA) | — | acquired polycythemia vera | 2014-08-05 | “FDA has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera” incyte.com ↗ |
| Filed atopic eczema 2 milestones | |||||
| Filed | US (FDA) | Opzelura | atopic eczema | 2024-10-29 | “In October 2024, the sNDA submission for ruxolitinib cream (Opzelura®) in pediatric atopic dermatitis was filed with the FDA” incyte.com ↗ “the NDA seeking approval of ruxolitinib cream as a treatment for patients with atopic dermatitis was submitted to the FDA” incyte.com ↗ “In October, the sNDA submission for ruxolitinib cream in pediatric atopic dermatitis was filed with the FDA” incyte.com ↗ |
| Filed | EU (EMA) | Opzelura | atopic eczema | — | “Data support Type-II variation application submitted for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU)” incyte.com ↗ “following the submission of a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the EU.” incyte.com ↗ |
| Filed familial myelofibrosis 6 milestones | |||||
| Filed | US (FDA) | XPOVIO | familial myelofibrosis | 2026-08-31 | “submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking Accelerated Approval for XPOVIO® (selinexor) in combination with ruxolitinib” karyopharm.com ↗ |
| Rejected (CRL) | US (FDA) | — | familial myelofibrosis | 2023-03-23 | “issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD” incyte.com ↗ “issued a complete response letter for ruxolitinib extended-release (XR) tablets” incyte.com ↗ |
| Filed | US (FDA) | — | familial myelofibrosis | 2023-02-07 | “Ruxolitinib XR (QD) (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD: NDA under review” incyte.com ↗ |
| Filed | US (FDA) | — | familial myelofibrosis | 2022-08-02 | “QD ruxolitinib (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD: clinical pharmacology studies; NDA under review” incyte.com ↗ “The LIMBER development program is advancing with the FDA acceptance of the NDA for once-daily (QD) ruxolitinib” incyte.com ↗ |
| Filed | US (FDA) | — | familial myelofibrosis | 2011-06-06 | “it has submitted a New Drug Application (NDA) for its lead investigational compound, ruxolitinib (INCB18424), to the US Food and Drug Administration (FDA)” incyte.com ↗ “New Drug Application (NDA) for ruxolitinib as a treatment for myelofibrosis filed and granted priority review by the US Food and Drug Administration (FDA)” incyte.com ↗ |
| Filed | EU (EMA) | — | familial myelofibrosis | — | “The Marketing Authorization Application for ruxolitinib as a treatment for MF was submitted to the European Medicines Agency” incyte.com ↗ |
| Filed vitiligo 2 milestones | |||||
| Filed | US (FDA) | Opzelura | vitiligo | 2021-12-14 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura™)” incyte.com ↗ |
| Filed | EU (EMA) | — | vitiligo | 2021-10-28 | “validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with nonsegmental vitiligo” incyte.com ↗ “On October 28, 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream” incyte.com ↗ “today announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream” incyte.com ↗ “validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream” incyte.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Filed | US (FDA) | Jakafi XR | — | 2026-02-10 | “A response to the ruxolitinib extended release (XR) complete response letter (CRL) issued by the U.S. Food and Drug Administration (FDA) has been submitted.” incyte.com ↗ |
| Label expansions (2) | US (FDA) | OPZELURA | — | 2022-07-18 – 2025-09-18 | fda.gov ↗ |
| Label expansions (8) | US (FDA) | JAKAFI | — | 2013-06-12 – 2022-12-19 | fda.gov ↗ |
| Approved | EU (EMA) | Jakavi | — | 2012-08-23 | europa.eu ↗ |
| Approved | US (FDA) | JAKAFI | — | 2011-11-16 | fda.gov ↗ |
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EU approved 2012
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06008275 | Sep 2024 → Jun 2026 overdue | triple-negative breast carcinoma | Baylor Research Institute | Recruiting | No outcome recorded |
| Phase 0 | NCT06209606 | Dec 2022 → May 2026 overdue | plasma cell myeloma | Oncotherapeutics | Recruiting | No outcome recorded |
| Phase 0 | NCT04906746 | Feb 2022 → Sep 2024 overdue | hypoproteinemia, hypercatabolic, non-small cell lung carcinoma | Tu Dan | Active not recruiting | No outcome recorded |
| Phase 0 | NCT02593929 | Jan 2017 → Jan 2018 | head and neck squamous cell carcinoma | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 159 trials | ||||||
| Phase 1 | NCT07801248 | Oct 2026 → Oct 2029 expected | acute graft versus host disease | Children's Hospital Medical Center, Cincinnati | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07849231 | Sep 2026 → Jun 2030 expected | myeloproliferative neoplasm | Damora Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT07424222 | Jul 2026 → Jul 2028 expected | secondary hemophagocytic lymphohistiocytosis | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 1 | NCT07588139 | May → Sep 2026 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT07464951 | May 2026 → May 2029 expected | acute myeloid leukemia | Stephan Grupp MD PhD | Recruiting | No outcome recorded |
| Phase 1 | NCT07566897 | May 2026 → Dec 2029 expected | clear cell renal carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07025538 | Apr 2026 → Jun 2028 expected | hematopoietic and lymphoid system neoplasm | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07548983 | Apr 2026 → Dec 2027 expected | acute myeloid leukemia | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT07278856 | Dec 2025 → Mar 2027 expected | Nodal T-follicular helper cell lymphoma, follicular type, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07049575 | Nov 2025 → Dec 2026 expected | hidradenitis suppurativa | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT06768476 | Feb 2025 → Mar 2045 expected | acute myeloid leukemia | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06695507 | Feb → Aug 2025 | chronic graft versus host disease | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT07576010 | Jan 2025 → Dec 2027 expected | acute graft versus host disease | Daihong Liu | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06291987 | Sep 2024 → May 2029 expected | myeloproliferative neoplasm | University of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT06225310 | Aug 2024 → Apr 2027 expected | plasma cell myeloma | Oncotherapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT06008808 | May 2024 → Sep 2027 expected | graft versus host disease | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06310304 | Mar → Apr 2024 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06213831 | Feb 2024 → Jul 2025 | prurigo nodularis | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06150157 | Dec 2023 → Dec 2026 expected | neoplasm | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT06034002 | Dec 2023 → Oct 2028 expected | myeloproliferative neoplasm | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT06673654 | Aug 2023 → Sep 2024 | atopic eczema | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05714072 | Jan 2023 → Jan 2027 expected | myelofibrosis | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05440942 | Jan 2023 → May 2025 | pancreatic ductal adenocarcinoma | Peter Hosein, MD | Completed | No outcome recorded |
| Phase 1 | NCT05034822 | Dec 2021 → Aug 2023 | atopic eczema | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05121142 | Oct 2021 → May 2023 | acute graft versus host disease, chronic graft versus host disease, disease related to solid organ transplantation | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT05010005 | Aug 2021 → Aug 2027 expected | T-cell large granular lymphocyte leukemia, T-cell prolymphocytic leukemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04480086 | Mar 2021 → Jul 2023 | myelofibrosis | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04279847 | Feb 2021 → Apr 2027 expected | essential thrombocythemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, myelofibrosis +1 | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04454658 | Nov 2020 → Jan 2027 expected | myelofibrosis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04456634 | Sep → Nov 2020 | malaria | Medicines for Malaria Venture | Completed | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04041050 | Nov 2019 → Dec 2026 expected | myeloproliferative neoplasm | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03874052 | Aug 2019 → Dec 2027 expected | acute myeloid leukemia | Jennifer Saultz | Recruiting | No outcome recorded |
| Phase 1 | NCT03920852 | May → Dec 2019 | atopic eczema | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03571321 | May 2019 → Sep 2026 overdue | childhood acute lymphoblastic leukemia | University of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT04303403 | Jul 2018 → Jun 2023 | colorectal cancer, pancreatic adenocarcinoma | National Cancer Centre, Singapore | Unknown | No outcome recorded |
| Phase 1 | NCT03514069 | Jun 2018 → Aug 2021 | glioblastoma | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03012230 | Dec 2017 → Jan 2023 | metastatic carcinoma in the bone, triple-negative breast carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT03257644 | Sep 2017 → Oct 2020 | atopic eczema | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03120624 | Sep 2017 → Aug 2023 overdue | carcinosarcoma of the corpus uteri, endometrial clear cell adenocarcinoma, endometrial endometrioid adenocarcinoma, endometrial mixed adenocarcinoma +2 | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03017820 | Apr 2017 → Dec 2028 expected | B-cell non-Hodgkin lymphoma, acute myeloid leukemia, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma +5 | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT03110822 | Feb 2017 → Sep 2024 overdue | plasma cell myeloma | Oncotherapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT02917096 | Nov 2016 → Apr 2020 | myelofibrosis, primary myelofibrosis | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02613598 | May 2016 → Jun 2021 | Hodgkins lymphoma, non-Hodgkin lymphoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02779283 | Jan 2016 → Apr 2018 | acute lymphoblastic leukemia, acute myeloid leukemia | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02528877 | Nov 2015 → Sep 2016 | acute myeloid leukemia, myelofibrosis, primary myelofibrosis | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT02493530 | Jul 2015 → Mar 2023 | acquired polycythemia vera, myelofibrosis | Vanderbilt-Ingram Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02494882 | Jun 2015 → Jun 2027 expected | acute lymphoblastic leukemia | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02370706 | May 2015 → Nov 2020 | myelofibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02145637 | May 2015 → Nov 2017 | non-small cell lung carcinoma | Yonsei University | Completed | No outcome recorded |
| Phase 1 | NCT02253277 | Feb 2015 → Mar 2018 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01895842 | Feb 2014 → Apr 2019 | leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01751425 | Jul 2013 → Sep 2019 | Philadelphia-positive myelogenous leukemia, chronic myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT01822756 | Apr 2013 → Sep 2015 | malignant pancreatic neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT01702064 | Feb 2013 → Oct 2016 | chronic myeloid leukemia | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01730248 | Dec 2012 → Sep 2017 | myelofibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT01433445 | Nov 2011 → Jun 2020 | myelofibrosis, primary myelofibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01317875 | Mar 2011 → Dec 2019 | myelofibrosis | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01164163 | Sep 2010 → Oct 2014 | childhood malignant neoplasm, leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1/252 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07796620 | Oct 2026 → Sep 2027 expected | acute leukemia, aplastic anemia, myelodysplastic syndrome | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07252050 | Jun 2026 → Nov 2028 expected | disease related to hematopoietic stem cell transplant, sickle cell disease, transplant rejection | Arkansas Children's Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06616155 | Jun 2026 → Jun 2028 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07311746 | Apr 2026 → Jan 2029 expected | T-cell prolymphocytic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07219576 | Jan 2026 → Dec 2027 expected | non-small cell lung carcinoma, renal cell carcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07128381 | Jan 2026 → Jul 2031 expected | chronic myelomonocytic leukemia, myelofibrosis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05745714 | Oct 2025 → Feb 2032 expected | T-lymphoblastic lymphoma, acute lymphoblastic leukemia | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06773195 | Jan 2025 → Jan 2028 expected | myelofibrosis | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06607367 | Oct 2024 → Oct 2025 overdue | idiopathic aplastic anemia | Melbourne Health | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05909943 | Jun 2024 → Feb 2026 | neuromyelitis optica | Tianjin Medical University General Hospital | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05998408 | Feb 2024 → Jul 2025 overdue | T-cell large granular lymphocyte leukemia, aplastic anemia, myelodysplastic syndrome | National Heart, Lung, and Blood Institute (NHLBI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05998395 | Sep 2023 → Feb 2025 | malignant atrophic papulosis | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 1/2 | NCT05123040 | Jun 2023 → Feb 2026 | acute graft versus host disease | Masonic Cancer Center, University of Minnesota | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05293717 | Jul 2022 → Jun 2023 | hand dermatosis | University of Rochester | Completed | No outcome recorded |
| Phase 1/2 | NCT04061421 | Nov 2021 → Aug 2027 expected | myelodysplastic/myeloproliferative neoplasm | Michael Savona | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05075681 | Nov 2021 → Jun 2024 | disease related to hematopoietic stem cell transplant | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04551131 | Jul 2021 → Nov 2025 overdue | hemophagocytic syndrome | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04856137 | May 2021 → Dec 2023 overdue | diffuse large B-cell lymphoma | National Health Research Institutes, Taiwan | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04817007 | Mar 2021 → Aug 2028 expected | myelofibrosis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04455841 | Mar 2021 → Apr 2025 | anemia, myelofibrosis | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT04582604 | Sep 2020 → Sep 2023 | disease related to hematopoietic stem cell transplant | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04334044 | Sep 2020 → Apr 2021 | COVID-19 | Grupo Cooperativo de Hemopatías Malignas | Completed | No outcome recorded |
| Phase 1/2 | NCT04269850 | Sep 2019 → Nov 2024 | acute graft versus host disease | St. Petersburg State Pavlov Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03491215 | Feb 2019 → Mar 2021 | acute graft versus host disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT03878199 | Feb 2019 → Feb 2025 | acquired polycythemia vera, acute myeloid leukemia, essential thrombocythemia, myelofibrosis | Ohio State University Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03773107 | Jan 2019 → Nov 2022 | plasma cell myeloma | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT04397367 | Jan 2019 → Jul 2020 | acute graft versus host disease | Chinese PLA General Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT03613428 | Dec 2018 → Dec 2020 | T-cell acute lymphoblastic leukemia | Sichuan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03681561 | Sep 2018 → Sep 2026 overdue | classic Hodgkin lymphoma | Veronika Bachanova | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03558607 | May 2018 → Apr 2022 | acute myeloid leukemia | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT02973711 | Jan 2018 → Aug 2021 | chronic myeloid leukemia | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03795909 | Mar 2017 → Mar 2020 | secondary hemophagocytic lymphohistiocytosis | Capital Research Institute of Pediatrics | Unknown | No outcome recorded |
| Phase 1/2 | NCT02912754 | Mar 2017 → Dec 2018 | B-cell chronic lymphocytic leukemia | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 1/2 | NCT02713386 | Nov 2016 → Sep 2021 | fallopian tube clear cell adenocarcinoma, fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, ovarian clear cell adenocarcinoma +4 | NRG Oncology | Completed | No outcome recorded |
| Phase 1/2 | NCT02742324 | Mar 2016 → Dec 2021 | myelofibrosis | French Innovative Leukemia Organisation | Completed | No outcome recorded |
| Phase 1/2 | NCT02806375 | Jan 2016 → Dec 2018 | primary myelofibrosis | St. Petersburg State Pavlov Medical University | Completed | No outcome recorded |
| Phase 1/2 | NCT02257138 | Feb 2015 → Mar 2021 | acute myeloid leukemia, myelodysplastic/myeloproliferative neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02158858 | Jul 2014 → Jan 2025 | acute myeloid leukemia, essential thrombocythemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm +3 | Constellation Pharmaceuticals | Completed | Met primary |
| Phase 1/2 | NCT02152956 | Jun 2014 → Jul 2022 | acute myeloid leukemia | MacroGenics | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02066532 | Jun 2014 → Oct 2020 | HER2 positive breast carcinoma | Dawn L. Hershman | Completed | No outcome recorded |
| Phase 1/2 | NCT02155465 | Jun 2014 → Oct 2017 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02015208 | Apr 2014 → Jul 2015 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 1/2 | NCT02041429 | Feb 2014 → May 2016 | breast carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02076191 | Feb 2014 → Jul 2018 | myeloproliferative neoplasm | John Mascarenhas | Completed | No outcome recorded |
| Phase 1/2 | NCT01914484 | Aug 2013 → Dec 2018 | acute lymphoblastic leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, leukemia, myeloid, accelerated-phase | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1/2 | NCT01644110 | Aug 2013 → Apr 2024 | myelofibrosis, myelofibrosis with myeloid metaplasia | University of Ulm | Completed | No outcome recorded |
| Phase 1/2 | NCT01787552 | May 2013 → Apr 2018 | acquired polycythemia vera, blood coagulation disease, essential thrombocythemia, hemorrhagic disease +1 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT01776723 | Feb 2013 → Nov 2018 | myeloid leukemia | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT01693601 | Jan 2013 → May 2018 | myelofibrosis | John Mascarenhas | Completed | No outcome recorded |
| Phase 1/2 | NCT01712659 | Oct 2012 → Nov 2021 | adult T-cell leukemia/lymphoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT01251965 | Dec 2010 → Jul 2012 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT00509899 | Jun → Dec 2007 | acquired polycythemia vera, myelofibrosis, thrombocytosis disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 2159 trials · 15 met primary · 8 missed | ||||||
| Phase 2 | NCT07643025 | Nov 2026 → Nov 2029 expected | chronic graft versus host disease | Dennis Kim | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07840456 | Nov 2026 → Feb 2029 expected | head and neck squamous cell carcinoma | University Hospital, Basel, Switzerland | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07783412 | Sep 2026 → Sep 2029 expected | pyoderma gangrenosum | Oregon Health and Science University | Recruiting | No outcome recorded |
| Phase 2 | NCT07356245 | Feb → Dec 2026 expected | T-cell prolymphocytic leukemia, adult T-cell leukemia/lymphoma, graft versus host disease, peripheral T-cell lymphoma, not otherwise specified +2 | Jonathan Brammer | Recruiting | No outcome recorded |
| Phase 2 | NCT07228624 | Feb 2026 → Sep 2030 expected | myelodysplastic/myeloproliferative neoplasm, myelofibrosis, primary myelofibrosis | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07359859 | Jan 2026 → Jan 2029 expected | hematopoietic and lymphoid cell neoplasm | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07249346 | Jan 2026 → Jun 2027 expected | chronic myelomonocytic leukemia, myelodysplastic syndrome | Hannah Choe, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07085039 | Dec 2025 → Jul 2028 expected | idiopathic multicentric Castleman disease | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT06987058 | Dec 2025 → Dec 2026 expected | acute myeloid leukemia, myelodysplastic syndrome | Ryvu Therapeutics SA | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07283822 | Dec 2025 → Jan 2028 expected | Hodgkins lymphoma, mediastinal gray zone lymphoma, peripheral T-cell lymphoma, not otherwise specified, primary cutaneous T-cell lymphoma +1 | Seda S. Tolu | Recruiting | No outcome recorded |
| Show all 159 trials opens the full record — a long page | ||||||
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT07297914 | Jan 2026 → Nov 2032 expected | acute graft versus host disease, acute lymphoblastic leukemia | Bambino Gesù Hospital and Research Institute | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06951971 | Jun 2025 → Jun 2027 expected | hemophagocytic syndrome | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT04348071 | Jul → Aug 2021 | COVID-19 | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04477993 | Aug 2020 → Mar 2021 | COVID-19 | Vanderson Geraldo Rocha | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT03117751 | Mar 2017 → Sep 2026 overdue | lymphoblastic leukemia, acute, with lymphomatous features | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT02962388 | Jan 2017 → Jun 2021 | essential thrombocythemia | French Innovative Leukemia Organisation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 342 trials · 14 met primary · 6 missed | ||||||
| Phase 3 | NCT07595939 | Jun 2026 → Dec 2028 expected | vitiligo | The Children's Hospital of Zhejiang University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07588945 | Jun 2026 → Dec 2027 expected | acute graft versus host disease | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06804811 | Nov 2025 → Apr 2027 expected | vitiligo | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06959225 | Jun 2025 → Oct 2026 expected | hidradenitis suppurativa | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06832618 | Jun 2025 → Jul 2026 overdue | atopic eczema | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06958211 | Jun 2025 → Oct 2026 expected | hidradenitis suppurativa | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06615050 | Apr 2025 → Jan 2031 expected | graft versus host disease | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06548360 | Jan 2025 → Jun 2028 expected | vitiligo | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06238817 | Apr 2024 → May 2025 | atopic eczema | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT05764161 | Jun 2023 → Dec 2024 | prurigo nodularis | Incyte Corporation | Completed | Missed primary |
| Phase 3 | NCT05755438 | Mar 2023 → Oct 2024 | prurigo nodularis | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT05233410 | Jan 2023 → Apr 2024 | — | Incyte Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05219864 | Jan 2023 → Apr 2024 | hand dermatosis | Incyte Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05456529 | Sep 2022 → May 2024 | atopic eczema | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT05137496 | Jun 2022 → Jun 2023 | macrophage activation syndrome | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04921969 | Jul 2021 → May 2023 | atopic eczema | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT04562389 | Mar 2021 → Feb 2026 overdue | myelofibrosis | Karyopharm Therapeutics Inc | Active not recruiting | Mixed |
| Phase 3 | NCT04472598 | Sep 2020 → Apr 2023 | myelofibrosis | AbbVie | Completed | Met primary |
| Phase 3 | NCT04530344 | Sep 2020 → Nov 2022 | vitiligo | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT04424056 | Sep 2020 → Sep 2022 | COVID-19 | Assistance Publique Hopitaux De Marseille | Unknown | No outcome recorded |
| Phase 3 | NCT04468984 | Aug 2020 → Jan 2025 overdue | myelofibrosis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04377620 | May 2020 → Feb 2021 | COVID-19 | Incyte Corporation | Terminated | Missed primary |
| Phase 3 | NCT04362137 | May → Oct 2020 | cytokine release syndrome | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT04116502 | Oct 2019 → Oct 2028 expected | acquired polycythemia vera | University of Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04057573 | Oct 2019 → Mar 2021 | vitiligo | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT04052425 | Sep 2019 → Mar 2021 | vitiligo | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT05663827 | Jan 2019 → Jan 2020 | — | Yi-Lun Wang | Completed | No outcome recorded |
| Phase 3 | NCT03745638 | Dec 2018 → Dec 2019 | atopic eczema | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT03745651 | Dec 2018 → Nov 2019 | atopic eczema | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT03533790 | Jun 2018 | hemophagocytic syndrome | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03112603 | Jun 2017 → May 2020 | chronic graft versus host disease | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT02913261 | Mar 2017 → Jun 2019 | acute graft versus host disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02292446 | Nov 2014 → Dec 2017 | acquired polycythemia vera | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02119663 | Jun 2014 → Feb 2016 | pancreatic ductal adenocarcinoma | Incyte Corporation | Terminated | Missed primary |
| Phase 3 | NCT02087059 | Apr 2014 → Mar 2015 | primary myelofibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02038036 | Mar 2014 → Sep 2015 | acquired polycythemia vera | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02117479 | Mar 2014 → Feb 2016 | pancreatic adenocarcinoma | Incyte Corporation | Terminated | Missed primary |
| Phase 3 | NCT01632904 | Jun 2012 → Mar 2014 | acquired polycythemia vera | Incyte Corporation | Completed | Missed primary |
| Phase 3 | NCT01493414 | Aug 2011 → Jan 2017 | myelofibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01243944 | Oct 2010 → Jan 2014 | acquired polycythemia vera | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT00952289 | Aug 2009 → Nov 2010 | myeloproliferative neoplasm | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT00934544 | Jul 2009 → Mar 2015 | myelofibrosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 415 trials | ||||||
| Phase 4 | NCT07661979 | Dec 2026 → Aug 2027 expected | atopic eczema | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06824103 | Sep 2025 → May 2029 expected | chronic graft versus host disease | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT07368673 | Apr → Dec 2025 | vitiligo | Dow University of Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT07101588 | Jan 2025 → Jan 2028 expected | disease related to hematopoietic stem cell transplant | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06504030 | Aug 2024 → Aug 2026 overdue | hemophagocytic syndrome | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06462469 | Jul 2024 → Sep 2026 overdue | acute graft versus host disease | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05696392 | Mar 2023 → Jan 2025 | atopic eczema | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05491304 | Sep 2022 → Dec 2024 | cytokine release syndrome, hemophagocytic syndrome | The Children's Hospital of Zhejiang University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT05447260 | Jun → Dec 2022 | myelofibrosis | Qilu Hospital of Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT04999878 | May 2021 → Jun 2023 | hemophagocytic syndrome, mature T-cell and NK-cell non-Hodgkin lymphoma | Zhengzhou University | Unknown | No outcome recorded |
| Phase 4 | NCT05021276 | Dec 2020 → Jul 2022 | — | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 4 | NCT04446806 | Jun 2019 → Dec 2020 | — | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 4 | NCT02386800 | Mar 2015 → Sep 2027 expected | acquired polycythemia vera, acute myeloid leukemia, graft versus host disease, primary myelofibrosis +1 | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01558739 | May 2012 → Jan 2014 | myelofibrosis with myeloid metaplasia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT07794514 | Oct 2026 → Apr 2030 expected | chronic graft versus host disease | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| — | NCT05899725 | Apr 2023 → Mar 2025 | drug or radiation exposure-related interstitial lung disease | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT04838704 | Apr 2021 → Dec 2024 | graft versus host disease | Zhejiang University | Completed | No outcome recorded |
| — | NCT04331665 | May 2020 → Jan 2021 | COVID-19, pneumonia | University Health Network, Toronto | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03274778 | Sep 2017 → Mar 2020 | prostate cancer | Oncology Institute of Southern Switzerland | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT02469974 | May 2015 → Aug 2016 | myelofibrosis | Marina Kremyanskaya | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase not stated6 trials | ||||||
| — | NCT05722912 | — | chronic graft versus host disease | Incyte Corporation | Approved for marketing | No outcome recorded |
| — | NCT04337359 | — | — | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT04355793 | — | COVID-19 | Incyte Corporation | No longer available | No outcome recorded |
| — | NCT01730755 | — | Chuvash polycythemia | Washington University School of Medicine | No longer available | No outcome recorded |
| — | NCT03147742 | — | graft versus host disease | Incyte Corporation | Approved for marketing | No outcome recorded |
| — | NCT05269771 | — | acquired polycythemia vera | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy64 trials | ||||||
| Phase 0 | NCT04744116 Background | Feb 2021 → Mar 2032 expected | acute graft versus host disease, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07521046 Background | Oct 2026 → Aug 2029 expected | myelofibrosis | University of Utah | Recruiting | No outcome recorded |
| Phase 1 | NCT07340138 Background | Apr → Jul 2026 overdue | myelofibrosis, primary myelofibrosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06233110 Background | Oct 2025 → Jan 2029 expected | chronic graft versus host disease | Stefanie Sarantopoulos, MD, PhD. | Recruiting | No outcome recorded |
| Phase 1 | NCT06508463 Background | Jan 2024 → Dec 2028 expected | anaplastic large cell lymphoma, mycosis fungoides, peripheral T-cell lymphoma, not otherwise specified | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT05936359 Background | Sep 2023 → Feb 2028 expected | myeloproliferative neoplasm | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05371964 Background | May 2022 → Feb 2027 expected | myelofibrosis | Geron Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05088356 Background | Sep 2021 → May 2028 expected | acute leukemia, chronic myeloid leukemia, disease related to hematopoietic stem cell transplant, myelodysplastic syndrome | Stanford University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04328844 Background | Feb 2020 → Dec 2023 overdue | myelofibrosis, non-Hodgkin lymphoma, non-small cell lung carcinoma, uveal melanoma | iOnctura | Active not recruiting | Met primary |
| Phase 1 | NCT03373877 Background | May 2018 → Oct 2019 | myelofibrosis, primary myelofibrosis | Samus Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03386214 Background | Apr 2018 → Sep 2021 | myelofibrosis | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT03515200 Background | Apr 2018 → Jul 2020 | acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT02960945 Comparator | Nov 2016 → Jan 2017 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02593760 Background | Jan 2016 → Mar 2017 | myelofibrosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02436135 Background | Jun 2015 → Nov 2017 | myelofibrosis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1/2 | NCT06887803 Background | Nov 2025 → Mar 2028 expected | myelofibrosis | iOnctura | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06909136 Background | Jul 2025 → Oct 2027 expected | myelofibrosis | Suzhou Junjing BioSciences Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06327100 Background | Aug 2024 → May 2029 expected | myelofibrosis, primary myelofibrosis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05280509 Background | Jun 2022 → Oct 2025 overdue | myelofibrosis, primary myelofibrosis | Telios Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04485260 Background | Jan 2021 → Oct 2022 | myelofibrosis | Kartos Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04354727 Background | Dec 2020 → Dec 2022 | myelofibrosis | Ascentage Pharma Group Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04581954 Comparator | Oct 2020 → Nov 2022 | COVID-19, pneumonia | Imperial College London | Completed | No outcome recorded |
| Phase 1/2 | NCT04176198 Background | Dec 2019 → Apr 2027 expected | myelofibrosis | Sumitomo Pharma America, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04097821 Background | Sep 2019 → May 2023 | myelofibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02711137 Background | May 2016 → Feb 2019 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT02587598 Background | Dec 2015 → Aug 2020 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT07572669 Background | Sep 2025 → Mar 2027 expected | acute graft versus host disease | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06923228 Comparator | Apr → Jul 2025 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06477549 Comparator | Jun 2024 → Jun 2028 expected | acute biphenotypic leukemia, lymphoblastic lymphoma, myelodysplastic syndrome | St. Petersburg State Pavlov Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06457425 Comparator | May 2024 → May 2026 overdue | — | Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT05980806 Background | Apr 2024 → Jun 2027 expected | myelofibrosis, thrombocytopenia | Karyopharm Therapeutics Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT06378060 Background | Mar 2024 → Apr 2026 overdue | aplastic anemia | Hematology department of the 920th hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06075706 Comparator | Nov 2023 → Feb 2026 overdue | acute graft versus host disease | medac GmbH | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05787860 Comparator | Nov 2022 → Jan 2024 | seborrheic dermatitis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT05037760 Background | Dec 2021 → Feb 2028 expected | myelofibrosis | Takeda | Recruiting | No outcome recorded |
| Phase 2 | NCT04118556 Comparator | Dec 2021 → Apr 2026 | acute graft versus host disease | Mats Remberger | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03669965 Comparator | Jan 2019 → Apr 2022 | acquired polycythemia vera | Kartos Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT03144687 Background | Jan 2018 → Mar 2020 | myeloproliferative neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02718300 Background | Feb 2017 → Jan 2021 | myeloproliferative neoplasm | Incyte Corporation | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT03333187 Comparator | Dec 2016 → Oct 2024 overdue | myelofibrosis | University Medical Center Hamburg-Eppendorf | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01981850 Background | Oct 2013 → Jul 2020 | acquired polycythemia vera, myelofibrosis, primary myelofibrosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01712308 Background | Feb 2013 → May 2022 | anemia, myelodysplastic/myeloproliferative neoplasm, myelofibrosis | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01369498 Background | Jun 2011 → Jun 2014 | myelofibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT07722611 Comparator | Oct 2026 → Jun 2032 expected | acquired polycythemia vera | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07366801 Comparator | Sep 2025 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06719024 Comparator | Nov 2024 → Jun 2025 overdue | vitiligo | Hospital Authority, Hong Kong | Recruiting | No outcome recorded |
| Phase 3 | NCT07357727 Background | May 2026 → May 2028 expected | myelofibrosis, primary myelofibrosis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07317700 Comparator | Feb 2026 → Dec 2027 expected | — | Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06479135 Background | Jun 2024 → Dec 2026 expected | myelofibrosis, primary myelofibrosis | Kartos Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06079879 Comparator | Dec 2023 → Jul 2027 expected | essential thrombocythemia | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04934670 Comparator | Jun → Nov 2022 | acute graft versus host disease | Xenikos | Terminated | No outcome recorded |
| Phase 3 | NCT04629833 Comparator | Aug 2021 → Aug 2027 expected | acute graft versus host disease | medac GmbH | Recruiting | No outcome recorded |
| Phase 3 | NCT04551053 Background | May 2021 → Aug 2023 | myelofibrosis, primary myelofibrosis | Incyte Corporation | Terminated | Missed primary |
| Phase 3 | NCT04551066 Background | May 2021 → Aug 2023 | myelofibrosis, primary myelofibrosis | Incyte Corporation | Terminated | Missed primary |
| Phase 3 | NCT04603495 Background | Apr 2021 → Aug 2023 overdue | myelofibrosis, primary myelofibrosis | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT04120090 Comparator | Jul 2019 → Jul 2020 | hemophagocytic syndrome | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03165734 Comparator | Jun 2017 → Oct 2026 expected | myelofibrosis, primary myelofibrosis | Swedish Orphan Biovitrum | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02598297 Comparator | Feb 2016 → Oct 2017 | myelofibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01969838 Comparator | Dec 2013 → Sep 2016 | myelofibrosis, primary myelofibrosis | Sierra Oncology LLC - a GSK company | Completed | Met primary |
| Phase 4 | NCT07498205 Comparator | Nov 2026 → Aug 2029 expected | myelofibrosis | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06364319 Background | Jul 2026 → Dec 2027 expected | chronic graft versus host disease | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05039580 Background | May 2021 → Apr 2023 | Epstein-Barr virus infection | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| — | NCT07184853 Background | Sep 2025 → Sep 2027 expected | graft versus host disease | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| — | NCT04745637 Background | — | acquired polycythemia vera, acute graft versus host disease, chronic graft versus host disease, myelofibrosis with myeloid metaplasia | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 167
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis karyopharm.com ↗
The sNDA submitted is based, in part, on data from the SENTRY trial that the Company believes supports a positive benefit-risk profile for the combination, including a promising signal of overall survival. |
| 2026-07-29 | Incyte Corporation | Regulatory Opzelura® (ruxolitinib) Cream Becomes First Steroid-Free Topical JAK Inhibitor Approved in the European Union for Adults with Moderate Atopic Dermatitis incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. |
| 2026-06-26 | Incyte Corporation | Regulatory Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis incyte.com ↗ |
| 2026-06-14 | Menarini Group | Results Menarini Group Reports Data from the Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis at The European Hematology Association (EHA) 2026 Congress menarini.com ↗
The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24. |
| 2026-06-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics presents clinical data and program update on romaciclib at the European Hematology Association Congress 2026 ryvu.com ↗
In the POTAMI-61 Phase II study, romaciclib demonstrates a favorable safety profile and clinical activity in myelofibrosis (MF), both as monotherapy and in combination with ruxolitinib (RUX). |
| 2026-06-02 | Karyopharm Therapeutics Inc | Results Karyopharm's Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis Selected for Late-Breaking Oral Presentation at EHA 2026 karyopharm.com ↗
New Data will Highlight a Post-Hoc Analysis from Phase 1 Portion of SENTRY Trial that Indicates Achievement of SVR35 with Selinexor plus Ruxolitinib May Predict Overall Survival |
| 2026-06-02 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Results from Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis in Late-Breaking Oral Presentation at ASCO 2026 with Simultaneous Publication in the Journal of Clinical Oncology karyopharm.com ↗
Selinexor in Combination with Ruxolitinib Demonstrated a Rapid and Near Doubling of Patients Achieving SVR35 at Week 24, versus Ruxolitinib, with a Consistent SVR35 Benefit Observed Across Prespecified Subgroups |
| 2026-05-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to present clinical data on romaciclib at the European Hematology Association Congress 2026 ryvu.com ↗
Romaciclib demonstrates a favorable safety profile and clinical activity in myelofibrosis, both as monotherapy and in combination with ruxolitinib (POTAMI-61). |
| 2026-05-07 | Incyte Corporation | Results Incyte Announces 24-Week Long-Term Data from Phase 3 TRuE-AD4 Trial of Opzelura® (ruxolitinib) Cream in Adults with Moderate Atopic Dermatitis incyte.com ↗
Incyte (Nasdaq:INCY) today announced final 24-week data from the Phase 3 TRuE-AD4 study evaluating the efficacy and safety of Opzelura® (ruxolitinib) cream in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). |
| 2026-05-01 | Incyte Corporation | Regulatory Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. |
| 2026-03-24 | Karyopharm Therapeutics Inc | Results Karyopharm's Phase 3 SENTRY Trial in Myelofibrosis Met First Co-Primary Endpoint, Demonstrating Statistically Significant Improvement in Spleen Volume Reduction karyopharm.com ↗
The mean change in absolute total symptom score (Abs-TSS) at week 24 relative to baseline was comparable across the two arms with similar symptom improvement relative to baseline; the difference across the two arms was not statistically significant. |
| 2026-03-20 | Incyte Corporation | Results Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting incyte.com ↗
Ruxolitinib Cream Improves Patient-Reported Outcomes in Adults With Moderate Atopic Dermatitis (TRuE-AD4) |
| 2025-12-07 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents New Clinical Data from RIVER-81 and POTAMI-61 Studies of Romaciclib (RVU120) at the 2025 ASH Annual Meeting ryvu.com ↗
romaciclib demonstrated encouraging signals of activity in MF with 7 of 14 patients evaluable for spleen volume demonstrating a reduction in spleen size of at least 10% |
| 2025-12-07 | Incyte Corporation | Results Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025 incyte.com ↗
Rapid and robust reductions in spleen volume and symptoms, and improvements in anemia were observed with INCA033989 as monotherapy and in combination with ruxolitinib (Jakafi®) in patients with myelofibrosis (MF) harboring a CALR mutation (mutCALR) |
| 2025-11-25 | Novartis Pharmaceuticals | Results Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCS novartis.com ↗
Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 study |
| 2025-10-25 | Incyte Corporation | Results Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis incyte.com ↗
At Week 8, 70% of patients treated with Opzelura achieved a ≥75% improvement in the Eczema Area and Severity Index (EASI75) and 61.3% achieved Investigator’s Global Assessment Treatment Success (IGA-TS), co-primary endpoints of the study |
| 2025-09-18 | Incyte Corporation | Regulatory Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis incyte.com ↗
Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD) |
| 2025-06-20 | Incyte Corporation | Regulatory Update on FDA Review of Ruxolitinib Cream (Opzelura®) for Children Ages 2-11 with Atopic Dermatitis incyte.com ↗ |
| 2025-06-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Data on RVU120 at the European Hematology Association Congress 2025 ryvu.com ↗
MF: Early data in patients with myelofibrosis (Phase II POTAMI-61) at 12 weeks of treatment show signs of efficacy, including 3 patients with an improvement in total symptom score (TSS) and 4 patients with a spleen size reduction. |
| 2025-05-28 | Geron Corporation | Results Geron Announces Presentations at ASCO and EHA Underscoring RYTELO® (imetelstat) Efficacy and Safety Across Range of LR-MDS Patients, and Showcasing Momentum of Myelofibrosis Program geron.com ↗
the combination of imetelstat and ruxolitinib was generally well-tolerated, with no dose-limiting toxicities observed as of the data cutoff date |
| 2025-03-08 | Incyte Corporation | Results Incyte Announces Results of Phase 3 Clinical Trials Evaluating Ruxolitinib Cream 1.5% (Opzelura®) in Patients with Prurigo Nodularis (PN) at 2025 American Academy of Dermatology Annual Meeting incyte.com ↗
The TRuE-PN1 study met its primary endpoint demonstrating that significantly more PN patients who applied ruxolitinib cream 1.5% versus vehicle control achieved a ≥4-point improvement from baseline in Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 (44.6% vs 20.6%; P=0.0003). |
| 2025-02-10 | Incyte Corporation | Results Incyte Reports 2024 Fourth Quarter and Year-End Financial Results, Provides 2025 Financial Guidance and Highlights 2025 R&D Milestones incyte.com ↗
Ruxolitinib extended-release (XR) has met the bioequivalence criteria set by the FDA; these data are anticipated to be submitted to the FDA by year-end 2025 |
| 2024-12-10 | Geron Corporation | Results Geron Announces Phase 1 Findings from Two-Part IMproveMF Study Presented at ASH Suggesting Tolerability of RYTELO™ (imetelstat) in Combination with Ruxolitinib as Frontline Therapy in Patients with Myelofibrosis geron.com ↗
The safety results from the dose escalation Part 1 suggest the tolerability of RYTELO™ (imetelstat), a first-in-class telomerase inhibitor, in combination with ruxolitinib as frontline therapy in patients with intermediate-1 (INT-1), intermediate-2 (INT-2) or high-risk (HR) myelofibrosis (MF). |
| 2024-11-05 | Geron Corporation | Results Geron Announces New Data to be Presented at Upcoming ASH Annual Meeting Highlighting the Potential of RYTELO™ (imetelstat) in Myeloid Hematologic Malignancies geron.com ↗
Early safety results from the dose escalation phase of the Phase 1 IMproveMF study suggest potential for the tolerability of combination therapy with imetelstat and ruxolitinib in a frontline myelofibrosis patient population |
| 2024-04-10 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Preclinical Data on RVU120 and Synthetic Lethality Programs at the 2024 AACR Annual Meeting ryvu.com ↗
RVU120 shows efficacy both as a monotherapy and synergistically in combination with ruxolitinib in preclinical models of myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. |
| 2024-03-10 | Incyte Corporation | Results Incyte Announces New Data from Phase 2 Study Evaluating Ruxolitinib Cream (Opzelura®) in Patients with Mild-to-Moderate Hidradenitis Suppurativa incyte.com ↗
The study met its primary endpoint, demonstrating a significantly greater reduction in abscess and inflammatory nodule (AN) count in patients treated with ruxolitinib cream 1.5%, compared to those who applied the vehicle control (least squares mean change of -3.61 for ruxolitinib cream 1.5% vs. -2.42 for vehicle control; P<0.05) at Week 16. |
| 2024-03-06 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to Present Preclinical Data on RVU120 and Synthetic Lethality Programs at the 2024 AACR Annual Meeting ryvu.com ↗
Poster presentation to highlight the synergistic effects of RVU120 in combination with ruxolitinib in myeloproliferative neoplasms. |
| 2024-01-08 | Incyte Corporation | Results Incyte Highlights Growth Opportunities and Provides Business Updates at the 42nd Annual J.P. Morgan Healthcare Conference incyte.com ↗
Notably, Incyte announces that the primary endpoint was met in its randomized, placebo-controlled, Phase 2 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura®) in adults with mild/moderate hidradenitis suppurative (HS). |
| 2023-12-10 | Karyopharm Therapeutics Inc | Results Karyopharm Shares Data at ASH 2023 Showing Strong SVR and TSS Durability Observed from Phase 1 Study of Selinexor 60mg and Ruxolitinib in JAK Inhibitor (JAKi)-Naïve Myelofibrosis Patients, with no SVR or TSS Progressions Observed As of the Data Cutoff(1) karyopharm.com ↗
In addition, all patients who achieved TSS50 at Week 24 remained in response as of the data cut-off. |
| 2023-10-13 | Incyte Corporation | Results Incyte Announces New Data for Ruxolitinib Cream (Opzelura®) in Children with Atopic Dermatitis incyte.com ↗
In the TRuE-AD3 trial, children (age ≥2 to <12 years old) with atopic dermatitis (AD) treated with ruxolitinib cream achieved significant efficacy, as defined by the Investigator’s Global Assessment-treatment success (IGA-TS), following eight weeks of treatment |
| 2023-10-11 | Incyte Corporation | Results New Long-Term Data from Incyte Phase 3 TRuE-V Program Demonstrates Efficacy of Continued Treatment with Opzelura® (Ruxolitinib) Cream in Nonsegmental Vitiligo Patients incyte.com ↗
Patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with Opzelura for up to two years |
| 2023-07-11 | Incyte Corporation | Results Incyte Announces Positive Topline Results from Phase 3 Trial Evaluating Ruxolitinib Cream (Opzelura®) in Children with Atopic Dermatitis incyte.com ↗
Incyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura®) in children (age ≥2 to <12 years) with atopic dermatitis (AD). |
| 2023-06-09 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Updated Clinical and Preclinical Data on RVU120 at the 2023 European Hematology Association Congress ryvu.com ↗
In vivo Data Show Synergistic Effects of RVU120 in Combination with Ruxolitinib in Myeloproliferative Neoplasms |
| 2023-06-01 | Gilead Sciences | Results Gilead and Kite Oncology Demonstrate Growing Hematology Pipeline and Strength of Leading Cell Therapy Portfolio at EHA gilead.com ↗
Ruxolitinib and Magrolimab increases Calreticulin in Myelofibrosis CD34+ Cells In Vitro: Proof of Concept for Combination Therapy |
| 2023-05-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to Present Clinical and Preclinical Data on RVU120 at the 2023 European Hematology Association Congress ryvu.com ↗
Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today announced that updated safety and efficacy data from the Phase 1b dose-escalation study of RVU120 in patients with Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (HR-MDS) and nonclinical data of RVU120 in combination with JAK1/2 inhibitor Ruxolitinib (RUX) in myeloproliferative neoplasms will be presented at the Annual European Hematology Association (EHA) 2023 Hybrid Congress, taking place June 8-11 in Frankfurt, Germany. |
| 2023-05-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023 bms.com ↗
Results from the dose-escalation components of a Phase 1/2 study evaluating BET inhibitor BMS-986158 as monotherapy and in combination with ruxolitinib or Inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. |
| 2023-05-01 | Incyte Corporation | Results Incyte Announces Results from SCRATCH-AD Trial Demonstrating Substantial and Rapid Itch Reduction in Patients with Mild-Moderate Atopic Dermatitis Treated with Opzelura® (ruxolitinib) Cream incyte.com ↗
Results showed that patients with AD treated with Opzelura experienced a rapid and substantial improvement in itch, which was sustained and further improved through 28 days of treatment. |
| 2023-04-20 | Incyte Corporation | Regulatory Incyte Announces European Commission Approval of Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has granted a marketing authorization for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. |
| 2023-04-18 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at AACR 2023 karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced updated results from the Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389). |
| 2023-03-23 | Incyte Corporation | Regulatory Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). |
| 2023-03-18 | Incyte Corporation | Results Incyte Announces Long-Term Extension Data from Phase 3 TRuE-V Program Demonstrating Long-Term Safety and Durability of Response of Opzelura® (Ruxolitinib) Cream in Vitiligo incyte.com ↗
Continued treatment with Opzelura for up to two years resulted in sustained facial repigmentation and further improvements in facial and total body repigmentation |
| 2023-03-03 | Incyte Corporation | Results Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis incyte.com ↗
Independent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study |
| 2023-02-24 | Incyte Corporation | Regulatory Incyte Announces Positive CHMP Opinion for Ruxolitinib Cream (Opzelura™) for the Treatment of Non-segmental Vitiligo in Adults and Adolescents incyte.com ↗ |
| 2022-12-12 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at ASH 2022 karyopharm.com ↗
today announced updated results from the Phase 1 portion of its study evaluating the safety and efficacy of once-weekly selinexor in combination with standard dose ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389). |
| 2022-12-10 | AbbVie | Results AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting for Investigational Navitoclax in Combination With Ruxolitinib for JAK Inhibitor-Naïve Myelofibrosis Patients abbvie.com ↗
The exploratory analysis suggests the combination of navitoclax and ruxolitinib led to reductions in bone marrow fibrosis (BMF) and variant allele frequency (VAF) for common genetic mutations found in individuals with myelofibrosis that may indicate potential disease modification. |
| 2022-12-10 | Incyte Corporation | Results Incyte Announces Data from Two LIMBER Studies Evaluating Combination Treatments in Patients with Myelofibrosis (MF) Presented at ASH 2022 incyte.com ↗
Phase 2 data demonstrate that the addition of parsaclisib to ruxolitinib (Jakafi®) resulted in spleen volume reduction and improvement in symptom burden in patients with myelofibrosis (MF) |
| 2022-11-22 | AbbVie | Results AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline at the 64th ASH Annual Meeting abbvie.com ↗
The Combination of Navitoclax and Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Mediates Responses Suggestive of Disease Modification |
| 2022-11-03 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress karyopharm.com ↗
Encouraging Data Observed in Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Activity Across Three Key Efficacy Endpoints, and a Generally Manageable Safety Profile with No Dose Limiting Toxicities. |
| 2022-11-03 | Karyopharm Therapeutics Inc | Results Karyopharm Announces New Selinexor Data in Myelofibrosis and Multiple Myeloma to be Presented at ASH 2022 karyopharm.com ↗
The presentations include results from the Phase 1 open-label, dose-escalation study of selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (MF) and data from a subset analysis of the STOMP study in patients with triple-class refractory MM. |
| 2022-10-19 | Incyte Corporation | Results Pivotal Phase 3 Data Showing Significant Improvements in Facial and Total Body Repigmentation with Ruxolitinib Cream (Opzelura™) in Vitiligo Published in New England Journal of Medicine incyte.com ↗
Fifty-two week data from the Phase 3 TRuE-V clinical trial program demonstrate an increase in the proportion of patients achieving repigmentation with longer duration of ruxolitinib cream treatment1 |
| 2022-07-18 | Incyte Corporation | Regulatory Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream for the Treatment of Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. |
| 2022-06-10 | AbbVie | Results AbbVie Presents Investigational Navitoclax Preliminary Data in JAK Inhibitor Naïve Myelofibrosis Patients abbvie.com ↗
AbbVie (NYSE: ABBV) today announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor naïve patients with myelofibrosis (MF), a rare and difficult to treat blood cancer. |
| 2022-05-26 | Karyopharm Therapeutics Inc | Results Karyopharm to Present New Selinexor Data at the 2022 American Society of Clinical Oncology Annual Meeting karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced promising initial data from a Phase 1/2 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and subgroup analyses and molecular classification data from the SIENDO study evaluating selinexor in endometrial cancer. |
| 2022-05-05 | Novartis Pharmaceuticals | Regulatory Novartis receives European Commission approval for Jakavi® to be the first post-steroid treatment for acute and chronic graft-versus-host disease novartis.com ↗
Basel, May 5, 2022 — Novartis today announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. |
| 2022-05-05 | Incyte Corporation | Regulatory Incyte Announces European Commission Approval of Jakavi® (ruxolitinib) as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease incyte.com ↗
Incyte (Nasdaq:INCY) today announced the European Commission (EC) has approved Jakavi® (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies. |
| 2022-04-12 | AbbVie | Results AbbVie Presents Positive Investigational Navitoclax Combination Data in Phase 2 REFINE Study Suggesting Anti-Fibrosis Activity for Patients with Myelofibrosis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced new data from a Phase 2 trial of navitoclax in combination with ruxolitinib in patients with myelofibrosis. |
| 2022-03-26 | Incyte Corporation | Results Incyte Announces 52-Week Data From the Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced new 52-week results from its pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream (Opzelura™), a topical JAK1/JAK2 inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. |
| 2022-03-25 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Jakavi® to treat acute and chronic graft-versus-host disease novartis.com ↗ |
| 2022-03-25 | Incyte Corporation | Regulatory Incyte Announces Positive CHMP Opinion for Ruxolitinib (Jakavi®) for the Treatment of Acute and Chronic Graft-Versus-Host Disease incyte.com ↗
“We are pleased that the CHMP has recommended approval of ruxolitinib for the treatment of acute or chronic GVHD in Europe,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. |
| 2022-03-14 | Incyte Corporation | Regulatory Incyte Announces U.S. FDA Has Extended the Supplemental New Drug Application Review Period for Ruxolitinib Cream (Opzelura™) for the Treatment of Vitiligo incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura™) for the treatment of vitiligo. |
| 2021-12-14 | Incyte Corporation | Regulatory Incyte Announces Acceptance and Priority Review of sNDA for Ruxolitinib Cream (Opzelura™) as a Treatment for Patients with Vitiligo incyte.com ↗
The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option. |
| 2021-10-28 | Incyte Corporation | Regulatory Incyte Announces the Validation of the European Marketing Authorization Application for Ruxolitinib Cream in Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream, a topical JAK inhibitor, as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. |
| 2021-10-02 | Incyte Corporation | Results Incyte Announces Full Results From Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. |
| 2021-09-22 | Incyte Corporation | Regulatory Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD) incyte.com ↗
Today’s approval marks the fourth FDA-approved indication for Jakafi, which received FDA-approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older |
| 2021-09-21 | Incyte Corporation | Regulatory Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD) incyte.com ↗
Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. |
| 2021-07-15 | Novartis Pharmaceuticals | Results Novartis announces NEJM publication of positive Phase III REACH3 data for Jakavi in chronic GvHD novartis.com ↗
REACH3 data show Jakavi significantly improved overall response rate (ORR) at week 24 (49.7% vs. 25.6%) with a higher best overall response rate (76.4% vs. 60.4%) vs. best available therapy, among steroid-refractory/dependent chronic graft-versus-host disease (GvHD) patients |
| 2021-07-14 | Incyte Corporation | Results Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease incyte.com ↗
Incyte (Nasdaq:INCY) today announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi®) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)1. |
| 2021-06-11 | Incyte Corporation | Regulatory Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD). |
| 2021-06-08 | Incyte Corporation | Regulatory Incyte Announces U.S. FDA Has Extended the sNDA Review Period for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease (GVHD) incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD). |
| 2021-05-17 | Incyte Corporation | Results Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age ≥12 years) with vitiligo. |
| 2021-04-23 | Incyte Corporation | Results Incyte Announces New Findings from a Randomized Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo incyte.com ↗
The results also add to previous findings indicating that a longer duration of therapy was associated with greater repigmentation, as assessed using the F-VASI and T-VASI responses at Weeks 24, 52 and 104. |
| 2021-04-23 | Incyte Corporation | Results Incyte Announces New Findings from Pooled Analyses of the Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients with Atopic Dermatitis incyte.com ↗
New findings from the analyses being presented at AAD VMX add to the growing body of evidence on ruxolitinib cream as a potential treatment for AD. |
| 2021-03-18 | Incyte Corporation | Results Incyte Announces Results from the Phase 3 DEVENT Study Evaluating Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) on Mechanical Ventilation incyte.com ↗
Improvement in mortality for each dose compared to placebo, while trending toward positive, was not statistically significant for the overall study population |
| 2021-02-22 | Incyte Corporation | Regulatory Incyte Announces Acceptance and Priority Review of sNDA for Jakafi® (ruxolitinib) as a Treatment for Patients with Chronic Graft-Versus-Host Disease incyte.com ↗ |
| 2021-02-19 | Incyte Corporation | Regulatory Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema. |
| 2021-01-21 | Oncotherapeutics | Results Efficacy and Safety of Ruxolitinib and Steroids for Treating Patients with Relapsed or Refractory Multiple Myeloma (RRMM). Results from the I-RUX Study Published in ASH2020 oncotherapeutics.com ↗
Of the 17 evaluable patients treated with RUX and steroids so far, the CBR and ORR were 53% (n=8) and 33% (n=5), respectively. |
| 2020-12-14 | Novartis Pharmaceuticals | Results Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19 novartis.com ↗
Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint |
| 2020-12-14 | Incyte Corporation | Results Incyte Announces Results of Phase 3 RUXCOVID Study of Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Cytokine Storm incyte.com ↗
Initial data show that treatment with ruxolitinib plus standard-of-care (SoC) did not prevent complications in patients with COVID-19 associated cytokine storm |
| 2020-12-04 | Novartis Pharmaceuticals | Results Novartis announces first data from REACH3 trial showing Jakavi® (ruxolitinib) significantly improved outcomes in patients with steroid-resistant/dependent chronic GvHD novartis.com ↗
In REACH3, patients treated with Jakavi achieved significantly greater overall response rate (ORR) compared to BAT (49.7% vs. 25.6%; p<0.0001 i ) at Week 24, the primary endpoint of the study 1 . |
| 2020-12-04 | Incyte Corporation | Results Incyte Announces First Data from REACH3 Trial Showing Ruxolitinib (Jakafi®) Significantly Improved Outcomes in Patients with Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease incyte.com ↗
Results of REACH3 trial also demonstrate significant improvements in failure-free survival (FFS) and patient-reported symptoms1 |
| 2020-10-29 | Incyte Corporation | Results Pooled Results from Incyte’s TRuE-AD1 and TRuE-AD2 Atopic Dermatitis Studies of Ruxolitinib Cream Show Clinically Meaningful Improvements in Patient-Reported Quality of Life Assessments incyte.com ↗
Incyte (Nasdaq:INCY) today announced efficacy and safety results from a pooled analysis of two randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream for the treatment of patients with mild-to-moderate atopic dermatitis (AD). |
| 2020-08-04 | Incyte Corporation | Results Incyte Reports 2020 Second Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗
Primary and both key secondary endpoints met in Phase 3 REACH3 trial of Jakafi in patients with steroid-refractory chronic graft-versus-host disease |
| 2020-07-23 | Novartis Pharmaceuticals | Results Novartis announces Phase III study of Jakavi® in chronic graft-versus-host disease met primary and key secondary endpoints novartis.com ↗
Novartis today announced that the Phase III REACH3 study evaluating Jakavi ® (ruxolitinib) in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GvHD) met its primary endpoint of superior overall response rate (ORR) at Week 24 versus best available therapy (BAT) 1 . |
| 2020-07-23 | Incyte Corporation | Results Incyte Announces REACH3 Trial of Ruxolitinib (Jakafi®) in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Secondary Endpoints incyte.com ↗
In addition, the study also met both key secondary endpoints, significantly improving failure-free survival (FFS) and patient-reported symptoms assessed by the modified Lee chronic GVHD symptom scale (mLSS). |
| 2020-04-22 | Novartis Pharmaceuticals | Results Novartis announces data showing Jakavi® (ruxolitinib) more effective than best available therapy in acute graft-versus-host disease novartis.com ↗
In REACH2, patients treated with Jakavi experienced significantly greater overall response rate (ORR) vs. BAT (62% vs. 39%; p<0.001) at Day 28, the primary endpoint of the study. |
| 2020-04-22 | Incyte Corporation | Results Incyte Announces Pivotal REACH2 Study Data Published in NEJM Highlight Superior Efficacy of Ruxolitinib (Jakafi®) versus Best Available Therapy in Patients with Acute Graft-Versus-Host Disease incyte.com ↗
In REACH2, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) vs. BAT (62% vs. 39%; p<0.001) at Day 28, the primary endpoint of the study. |
| 2020-04-05 | Incyte Corporation | Results Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium incyte.com ↗
Data that will be presented today during the Revolutionizing Atopic Dermatitis Virtual Symposium show that ruxolitinib cream significantly reduced both the skin inflammation and itch associated with atopic dermatitis. |
| 2020-02-19 | Incyte Corporation | Results Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the second randomized, vehicle-controlled, pivotal Phase 3 study from the TRuE-AD clinical trial program has met its primary endpoint. |
| 2020-01-28 | Incyte Corporation | Results Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis incyte.com ↗
Incyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD2 study evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥ 12 years) with atopic dermatitis (AD). |
| 2019-10-29 | Incyte Corporation | Results Incyte Reports 2019 Third Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗
Multiple positive developments within late-stage clinical portfolio, including New Drug Application (NDA) submission for pemigatinib, successful outcome of ruxolitinib REACH2 trial and updated data from ruxolitinib cream showing continued improvement in repigmentation of vitiligo lesions |
| 2019-10-16 | Novartis Pharmaceuticals | Results Novartis announces that Jakavi® (ruxolitinib) meets primary endpoint in Phase III study of acute graft-versus-host disease novartis.com ↗
The study met its primary endpoint of superior overall response rate (ORR) at day 28 of treatment with Jakavi, compared with best available therapy (BAT)[1]. |
| 2019-10-16 | Incyte Corporation | Results Incyte Announces that the REACH2 Pivotal Trial of Ruxolitinib (Jakafi®) Meets Primary Endpoint in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease incyte.com ↗
The study met its primary endpoint of improving overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available therapy. |
| 2019-10-12 | Incyte Corporation | Results Incyte Announces Positive 52-Week Results From a Randomized Phase 2 Study of Ruxolitinib Cream in Patients With Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announces positive 52-week results from its randomized, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo. |
| 2019-06-15 | Incyte Corporation | Results Incyte Announces Positive Results from a Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announces 24-week results from its randomized, double-blind, dose-ranging, vehicle-controlled, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients (18 to 75 years of age) with vitiligo. |
| 2019-05-24 | Incyte Corporation | Regulatory FDA Approves Jakafi® (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease incyte.com ↗
Incyte Corporation (Nasdaq:INCY)today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. |
| 2019-04-30 | Incyte Corporation | Results Incyte Reports 2019 First Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗ |
| 2019-02-07 | Incyte Corporation | Regulatory Incyte Announces U.S. FDA Has Extended the Review Period for Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease incyte.com ↗
The FDA extended the action date to allow time to review additional data submitted by Incyte in response to the FDA’s information requests. |
| 2018-12-03 | Incyte Corporation | Results Results of REACH1 Study of Ruxolitinib (Jakafi®) for the Treatment of Acute Graft-Versus-Host Disease Demonstrate Rapid and Durable Patient Benefit incyte.com ↗
Responses to ruxolitinib were rapid and durable; the median time to response was seven days and the median duration of response (DOR) for patients who had a minimum of six months of follow-up was 345 days. |
| 2018-10-25 | Incyte Corporation | Regulatory FDA Grants Priority Review for Ruxolitinib (Jakafi®) as a Treatment for Patients with Acute Graft-Versus-Host Disease incyte.com ↗ |
| 2018-09-13 | Incyte Corporation | Results Incyte Announces Positive Data from Phase 2b Trial of Ruxolitinib Cream in Patients with Atopic Dermatitis incyte.com ↗
Incyte Corporation (Nasdaq:INCY)today announced positive results from its randomized, dose-ranging, vehicle- and active-controlled Phase 2b study evaluating ruxolitinib cream in patients with atopic dermatitis (AD) who are candidates for topical therapy. |
| 2018-07-31 | Incyte Corporation | Results Incyte Reports 2018 Second Quarter Financial Results and Updates on Key Clinical Programs incyte.com ↗
Pivotal REACH1 study of Jakafi in steroid-refractory acute GVHD met primary endpoint; sNDA submission expected in Q3 2018 |
| 2018-06-21 | Incyte Corporation | Results Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi®) in Steroid-Refractory Acute Graft-Versus-Host Disease incyte.com ↗
The study met its primary endpoint, demonstrating an overall response rate (ORR) of 55 percent (n=39/71) at Day 28. |
| 2018-06-15 | Novartis Pharmaceuticals | Results Novartis study of real-world data concludes Jakavi is associated with a reduction in risk of death and dangerous blood clots for patients with rare blood cancer novartis.com ↗
In the GEMFIN study, patients treated with Jakavi had a significantly prolonged overall survival (HR=0.28 [0.11-0.72]) and a lower risk of blood clots (HR=0.21 [0.06-0.76]) when compared to real-world patients treated with BAT[1]. |
| 2017-12-10 | Incyte Corporation | Results Four-Year Phase 3 Data Analysis Shows Durability of Response of Jakafi® (ruxolitinib) in Patients with Polycythemia Vera incyte.com ↗
The pre-planned data analysis showed a durable primary response to Jakafi in patients with PV who are resistant to or intolerant of HU and the overall safety profile for Jakafi remained consistent with previously reported 80-week RESPONSE data. |
| 2016-12-06 | Geron Corporation | Results Geron Reports Imetelstat Presentations at American Society of Hematology Annual Meeting geron.com ↗
Among patients who failed or discontinued frontline ruxolitinib, the median overall survival was seven months, which underscores the need for new treatment options for this disease. |
| 2016-12-04 | Incyte Corporation | Results Pooled Analysis of Five-Year Data from Two Phase 3 Studies Further Supports Overall Survival Advantage Observed in Patients with Myelofibrosis Treated With Jakafi® (ruxolitinib) incyte.com ↗
Ruxolitinib also exhibited an overall survival (OS) advantage in various patient subgroup analyses including age, sex, disease type, risk status, JAK2V617F mutation status, baseline spleen length, anemia, white blood cell count, and platelet count. |
| 2016-11-16 | Gilead Sciences | Results Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Momelotinib for Patients With Myelofibrosis gilead.com ↗
During 24 weeks of treatment in SIMPLIFY-1, the most frequent adverse events in patients receiving momelotinib were thrombocytopenia, diarrhea, headache, dizziness and nausea; the most frequent adverse events in patients receiving ruxolitinib were anemia, thrombocytopenia, diarrhea, headache and dizziness. |
| 2016-06-23 | Incyte Corporation | Regulatory FDA Grants Breakthrough Therapy Designation for Incyte’s Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease (GVHD) incyte.com ↗
Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). |
| 2016-06-10 | Novartis Pharmaceuticals | Results Novartis presents data showing Jakavi® is superior to best available therapy in patients with less advanced polycythemia vera (PV) novartis.com ↗
Three times as many patients with inadequately controlled PV without enlarged spleen had hematocrit control without phlebotomy on Jakavi ® (ruxolitinib) vs BAT[1] |
| 2016-06-10 | Incyte Corporation | Results New Phase 3 Data Show Jakafi® (ruxolitinib) is Superior to Best Available Therapy in Patients with Polycythemia Vera (PV) incyte.com ↗
The data show that Jakafi was superior to best available therapy (BAT) in maintaining hematocrit control (62.2% vs. 18.7%, respectively; P<0.0001)1 without the need for phlebotomy in patients with inadequately controlled polycythemia vera (PV) resistant to or intolerant of hydroxyurea (HU) who did not have an enlarged spleen. |
| 2016-06-06 | Incyte Corporation | Results Five-year Results from Phase 3 Study of Jakafi® (ruxolitinib) Show Sustained Overall Survival Benefit in Patients with Myelofibrosis (MF) incyte.com ↗
Incyte Corporation (Nasdaq:INCY) today announces five-year data from the Phase 3 COMFORT-I study evaluating the long-term safety and efficacy of Jakafi® (ruxolitinib) in patients with intermediate-2 or high-risk myelofibrosis (MF). |
| 2016-02-11 | Incyte Corporation | Results Incyte Announces Decision to Discontinue JANUS Studies of Ruxolitinib plus Capecitabine in Patients with Advanced or Metastatic Pancreatic Cancer incyte.com ↗
The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation. |
| 2016-01-27 | Incyte Corporation | Results Incyte Announces Decision to Stop Phase 2 Sub-study of Ruxolitinib Plus Regorafenib in Patients with Metastatic Colorectal Cancer and High CRP incyte.com ↗
The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show a sufficient level of efficacy to warrant continuation. |
| 2015-12-05 | Novartis Pharmaceuticals | Results Novartis announces Phase III studies of Jakavi show disease improvement in patients with myelofibrosis and polycythemia vera novartis.com ↗
Phase III results show Jakavi met primary endpoint in inadequately controlled polycythemia vera (PV) patients without enlarged spleen |
| 2015-12-05 | Incyte Corporation | Results Two Phase 3 Studies Reinforce Sustained Benefits of Treatment with Jakafi® (ruxolitinib) in Patients with Myeloproliferative Neoplasms (MPNs) incyte.com ↗
COMFORT-II data demonstrate that patients with myelofibrosis treated with Jakafi achieved a 33 percent reduction in the risk of death after five years |
| 2015-12-05 | Incyte Corporation | Results Phase 3 RESPONSE-2 Study of Jakafi® (ruxolitinib) Meets Primary Endpoint incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announces the Phase 3 RESPONSE-2 study of Jakafi® (ruxolitinib) met its primary endpoint. |
| 2015-06-13 | Novartis Pharmaceuticals | Results Novartis announces data show majority of patients with polycythemia vera treated with Jakavi® achieved long-term disease control novartis.com ↗
Preplanned analysis at 18 months demonstrate 80% of PV patients treated with Jakavi ® (ruxolitinib) experienced a durable response for at least one year[1] |
| 2015-05-27 | Incyte Corporation | Results Incyte Clinical Portfolio to be Featured in 23 Abstract Presentations at the 2015 ASCO and EHA Annual Meetings incyte.com ↗
Follow-up results from pivotal RESPONSE trial of ruxolitinib in patients with uncontrolled polycythemia vera, showing 83% of patients were still receiving ruxolitinib at a median exposure of 111 weeks |
| 2015-03-17 | Novartis Pharmaceuticals | Regulatory Novartis receives EU approval for Jakavi® in polycythemia vera, first targeted therapy approved for patients with this rare blood cancer novartis.com ↗
Basel, March 17, 2015 - Novartis announced today that the European Commission has approved Jakavi ® (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. |
| 2015-03-17 | Incyte Corporation | Regulatory Jakavi® (ruxolitinib) Receives European Commission Approval as First Targeted Therapy for Patients with Polycythemia Vera incyte.com ↗
Incyte Corporation (Nasdaq: INCY) announced today that Novartis received approval from the European Commission for Jakavi® (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. |
| 2015-01-28 | Novartis Pharmaceuticals | Results Novartis announces study in NEJM showing Jakavi® was superior to standard therapy in rare blood cancer polycythemia vera novartis.com ↗
Jakavi ® (ruxolitinib) treatment resulted in durable hematocrit control, spleen size reduction and symptom relief for patients with uncontrolled polycythemia vera[1] |
| 2015-01-28 | Incyte Corporation | Results Incyte Announces Publication of Phase III RESPONSE Trial in Patients with Polycythemia Vera in New England Journal of Medicine incyte.com ↗
Data show Jakafi® (ruxolitinib) was superior to standard therapy; resulting in durable hematocrit control, spleen volume reduction and complete hematological remission in patients with uncontrolled polycythemia vera (PV)1 |
| 2015-01-23 | Novartis Pharmaceuticals | Regulatory Novartis drug Jakavi® recommended by CHMP for EU approval to treat adults with rare blood cancer polycythemia vera novartis.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Jakavi ® (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea[2]. |
| 2015-01-23 | Incyte Corporation | Regulatory Incyte Earns $25 Million Milestone as Jakavi® (ruxolitinib) Recommended for Approval in Europe for Polycythemia Vera incyte.com ↗
This recommendation for approval in Europe, the second indication for Jakavi and many months ahead of schedule, is further evidence that our innovative scientific advances can offer significant benefit to patients. |
| 2014-12-04 | Incyte Corporation | Regulatory FDA Approves Jakafi® (ruxolitinib) for the Treatment of Patients with Uncontrolled Polycythemia Vera incyte.com ↗
Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. |
| 2014-08-05 | Incyte Corporation | Regulatory FDA Accepts Supplemental New Drug Application for Jakafi® (ruxolitinib) and Priority Review Granted incyte.com ↗
“We are pleased to have received the acceptance of our sNDA filing by the FDA, and we believe that the submission contains a robust data set,” stated Richard Levy, M.D., Executive Vice President and Chief Drug Development and Medical Officer of Incyte. |
| 2014-07-28 | Incyte Corporation | Regulatory Jakafi® (ruxolitinib) Product Label Expanded to Include Overall Survival Data and Additional Safety and Dosing Information incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food & Drug Administration (FDA) has approved supplemental labeling for Jakafi® (ruxolitinib) to include new Kaplan-Meier overall survival curves as well as additional safety and dosing information. |
| 2014-07-23 | Incyte Corporation | Results Incyte Announces Top-Line Results from RELIEF Trial of Ruxolitinib in Patients with Polycythemia Vera incyte.com ↗
Topline results showed a 43.4% symptom response rate in the ruxolitinib arm and a 29.6% symptom response rate in the hydroxyurea arm (p=0.139). |
| 2014-06-03 | Incyte Corporation | Results Pivotal Phase III Data in Polycythemia Vera Show that Jakafi® (ruxolitinib) Achieved Superior Disease Control Compared to Best Available Therapies incyte.com ↗
Ruxolitinib, compared to best available therapy (BAT), significantly improved hematocrit control (red blood cell volume) without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and reduced spleen size in patients with uncontrolled PV -- those who are resistant to or intolerant of hydroxyurea (HU). |
| 2014-06-02 | Incyte Corporation | Results Incyte Announces Full Results from Proof-of-Concept Phase II RECAP Trial of Jakafi® (ruxolitinib) in Combination with Capecitabine in Patients with Metastatic Pancreatic Cancer incyte.com ↗
The findings from this proof-of-concept trial showed that ruxolitinib plus capecitabine prolonged survival over capecitabine alone in patients with elevated C-reactive protein (CRP), a well-established marker of systemic inflammation (hazard ratio = 0.47; 95% CI, 0.26-0.85; P=0.01 (2-sided)). |
| 2014-03-07 | Incyte Corporation | Results Incyte Announces Positive Top-Line Results from Phase III Study of Ruxolitinib in Patients with Polycythemia Vera incyte.com ↗
Study of ruxolitinib versus best available therapy for patients with polycythemia vera who are resistant to or intolerant of hydroxyurea met primary endpoint |
| 2014-02-12 | Incyte Corporation | Regulatory Incyte Reports 2013 Fourth-Quarter and Year-End Financial Results; Provides 2014 Financial Guidance; Updates Shareholders on Key Clinical Programs incyte.com ↗
The Company also provided 2014 financial guidance and highlighted multiple achievements in its clinical programs, including agreement with the FDA for a Special Protocol Assessment (SPA) for a registration trial of ruxolitinib in patients with advanced or metastatic pancreatic cancer. |
| 2013-12-09 | Incyte Corporation | Results Jakafi® (ruxolitinib) Continues to Show Improved Overall Survival for Patients with Myelofibrosis in Further Analyses of Phase III Data Presented at 2013 ASH incyte.com ↗
Data from multiple presentations, including three-year follow-up analysis from COMFORT-I and a pooled analysis of the two COMFORT trials, suggest that patients treated with Jakafi maintained reductions in spleen volume and had improved survival over placebo and best available therapy |
| 2013-10-31 | Incyte Corporation | Results Incyte Reports Third-Quarter 2013 Financial Results; Updates Shareholders on Key Clinical Programs incyte.com ↗
Top-line results from Phase II trial of ruxolitinib in patients with refractory metastatic pancreatic cancer suggest a demonstrable survival benefit in a well-defined subgroup of patients |
| 2013-08-21 | Incyte Corporation | Results Incyte Provides Top-Line Results from Phase II Proof-of-Concept Trial of Ruxolitinib in Patients with Refractory Metastatic Pancreatic Cancer incyte.com ↗
Incyte Corporation (Nasdaq: INCY) announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, its oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer. |
| 2013-06-16 | Incyte Corporation | Results Incyte Drug Jakafi® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients with Myelofibrosis incyte.com ↗
Results from a Phase I/II study also presented at EHA offer evidence that long-term treatment with Jakafi may stabilize or reverse bone marrow fibrosis, a key marker of worsening disease in patients with myelofibrosis |
| 2013-06-12 | Incyte Corporation | Regulatory Jakafi® (ruxolitinib) Prescribing Information Updated with Expanded Dosing Guidance and New Safety Information incyte.com ↗
Incyte Corporation (Nasdaq: INCY) announced today that the U.S. Food and Drug Administration (FDA) has updated prescribing information for Jakafi® (ruxolitinib) to include new recommended dosing guidance for patients with low platelet counts and additional safety information. |
| 2013-06-04 | Incyte Corporation | Results Data Presented at 2013 ASCO Offers First Evidence that Long-Term Treatment with Jakafi® (ruxolitinib) May Stabilize or Reverse Bone Marrow Fibrosis, a Key Marker of Worsening Disease in Patients with Myelofibrosis incyte.com ↗
These results provide the first evidence of a drug therapy that may stabilize or improve bone marrow fibrosis and are encouraging because the only other proven option is bone marrow transplantation, which is a procedure with high risks. |
| 2012-12-10 | Incyte Corporation | Results New Data for Jakafi® (ruxolitinib) Presented at the 2012 American Society of Hematology Annual Meeting incyte.com ↗
Two of the oral presentations highlight long-term results from both COMFORT-I and COMFORT-II in which patients with MF treated with Jakafi had improved survival over placebo and best available therapy, suggesting an overall survival benefit in patients with intermediate or high-risk MF. |
| 2012-11-01 | Incyte Corporation | Regulatory Incyte Reports 2012 Third-Quarter Financial Results; Updates Shareholders on Launch of Jakafi and Lead Clinical Programs incyte.com ↗
Novartis, the Company’s collaboration partner, announced that Jakafi, marketed as Jakavi® outside the United States, received approval from the European Commission for the treatment of disease-related splenomegaly or symptoms in adult patients with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. |
| 2012-08-28 | Incyte Corporation | Regulatory Jakavi® (ruxolitinib) First Medication to Receive European Commission Approval to Treat Patients with Myelofibrosis incyte.com ↗ |
| 2012-06-04 | Incyte Corporation | Results New Data for Jakafi® (ruxolitinib) Presented at 2012 ASCO Annual Meeting incyte.com ↗
A dosing strategy starting with 5 mg twice daily with subsequent dose optimization resulted in reductions in spleen size and improvements in MF-related symptoms at 24 weeks in most patients. |
| 2012-04-20 | Incyte Corporation | Regulatory Incyte Announces EU Regulatory Milestone for Ruxolitinib incyte.com ↗
Incyte Corporation (Nasdaq: INCY) announced today a European Union (EU) regulatory milestone from Novartis. |
| 2012-02-29 | Incyte Corporation | Results Phase III studies of Jakafi™ (ruxolitinib) published in The New England Journal of Medicine Demonstrate Significant Clinical Benefit for Patients with Myelofibrosis incyte.com ↗
Results from the COMFORT-I and COMFORT-II Phase III trials show Jakafi significantly reduced spleen volume and debilitating symptoms associated with myelofibrosis (MF), a life-threatening blood cancer |
| 2011-12-12 | Incyte Corporation | Results First FDA-Approved Treatment for Myelofibrosis, Jakafi™ (ruxolitinib), Discussed in Multiple Presentations at 2011 ASH Annual Meeting incyte.com ↗
Consistent benefit of ruxolitinib over placebo in spleen volume reduction and symptom improvement across subgroups and overall survival advantage: results from COMFORT-I. |
| 2011-11-16 | Incyte Corporation | Regulatory FDA Approves Incyte's Jakafi(TM) (ruxolitinib) for Patients with Myelofibrosis incyte.com ↗
Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Jakafi™ (ruxolitinib) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. |
| 2011-10-27 | Incyte Corporation | Regulatory Incyte Reports Third Quarter 2011 Financial Results and Provides Update on Key Clinical Programs incyte.com ↗
The FDA accepted for filing the NDA and granted Incyte's request for priority review and has a goal to complete the review within six months. |
| 2011-08-03 | Incyte Corporation | Regulatory FDA Accepts NDA Filing for Ruxolitinib as a Treatment for Myelofibrosis incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Incyte's lead investigational compound, ruxolitinib (INCB18424/INC424), as a potential treatment for patients with myelofibrosis (MF). |
| 2011-06-11 | Incyte Corporation | Results Incyte Reports Additional Analyses of Symptomatic Improvement and Quality of Life with Ruxolitinib (INC424) in Patients with Myelofibrosis from the COMFORT-I Study incyte.com ↗
These data demonstrated that the primary endpoint of a 35% reduction in spleen volume was clearly associated with reduction of abdominal symptoms (abdominal discomfort, pain under the ribs and feeling of fullness (early satiety)) associated with an enlarged spleen. |
| 2011-06-06 | Incyte Corporation | Regulatory Incyte Submits New Drug Application for Ruxolitinib in Myelofibrosis to the US Food and Drug Administration incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced today that it has submitted a New Drug Application (NDA) for its lead investigational compound, ruxolitinib (INCB18424), to the US Food and Drug Administration (FDA). |
| 2011-06-04 | Incyte Corporation | Results Incyte Announces Ruxolitinib (INC424) Shows Significant Clinical Benefit for Myelofibrosis Patients in Two Phase III Studies at ASCO Annual Meeting incyte.com ↗
Ruxolitinib-treated patients experienced significant reductions in splenomegaly and improvement in symptoms and overall quality of life measures while patients in the control arms, (placebo and best available therapy [BAT]), experienced progressive splenomegaly and worsening of symptoms. |
| 2011-03-15 | Incyte Corporation | Results Incyte's Ruxolitinib (INCB18424) Meets Primary Endpoint in Second Phase III Study incyte.com ↗
Data from Novartis COMFORT-II European Phase III trial show treatment with ruxolitinib provided a statistically significant reduction in spleen size in patients with myelofibrosis when compared with best available therapy |
| 2010-12-20 | Incyte Corporation | Results Incyte Announces Positive Top-Line Results from COMFORT-I Pivotal Phase III Trial of INCB18424 in Myelofibrosis, a Debilitating, Life-Threatening Blood Cancer incyte.com ↗
The response rate was 42% in patients randomized to INCB18424 versus less than 1% of patients randomized to placebo; thus a high level of statistical significance (p < 0.0001) was achieved. |
| 2010-12-06 | Incyte Corporation | Results Incyte Presents Positive Long-Term Results from Ongoing Phase II Trial of INCB18424 in Advanced Polycythemia Vera (PV) and Essential Thrombocythemia (ET) at the American Society of Hematology Annual Meeting incyte.com ↗
Incyte Corporation (NASDAQ:INCY)presentedpositive long-term clinical results today from an ongoing open-label Phase II trial for INCB18424, its selective, oral JAK1 and JAK2 inhibitor, in patients with advanced polycythemia vera (PV) and essential thrombocythemia (ET). |
| 2010-09-15 | Incyte Corporation | Results Phase I/II Data Published in New England Journal of Medicine Demonstrate that Incyte JAK Inhibitor, INCB18424, Provides Marked and Durable Clinical Benefits in Patients with Myelofibrosis, a Rare, Life-Threatening Blood Cancer incyte.com ↗
Results from a Phase I/II study of Incyte's janus kinase (JAK) inhibitor with the investigational name INCB18424 (also known as INCB018424 and INC424) were published today in The New England Journal of Medicine, demonstrating marked and durable clinical benefits in patients with myelofibrosis. |
| 2010-09-13 | Incyte Corporation | Regulatory Incyte Reaches Agreement with the FDA on a Special Protocol Assessment for the Phase III Clinical Trial of INCB18424 in Polycythemia Vera incyte.com ↗ |
| 2009-12-07 | Incyte Corporation | Results Data from Three Phase II Trials to be Presented at the 51st American Society of Hematology Annual Meeting Demonstrate that INCB18424, a Selective JAK1/JAK2 Inhibitor, Has Potential in Multiple Hematology Conditions incyte.com ↗
INCB18424 continues to provide durable and previously unachievable clinical benefits in patients with myelofibrosis with or without JAK2 activating mutations. |
| 2009-09-21 | Incyte Corporation | Results Incyte Announces Positive Top-Line Phase IIb Results for Topical INCB18424 in Psoriasis incyte.com ↗
Incyte Corporation (Nasdaq:INCY) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. |
| 2009-07-21 | Incyte Corporation | Regulatory Incyte Reaches Agreement with FDA on a Special Protocol Assessment for INCB18424 in Myelofibrosis incyte.com ↗
The SPA provides agreement that the study design and planned analysis of the Phase III trial adequately address objectives in support of a regulatory submission. |
| 2008-12-06 | Incyte Corporation | Results Incyte's Selective JAK1 / 2 Inhibitor, INCB18424, Demonstrates Rapid and Durable Clinical Benefits in Myelofibrosis Patients incyte.com ↗
Important and previously unachievable clinical benefits observed in this study include striking improvement in splenomegaly and the debilitating constitutional symptoms that plague the majority of these patients. |
| 2008-10-26 | Incyte Corporation | Results Incyte's JAK Inhibitor Demonstrates Rapid and Marked Clinical Improvement in Rheumatoid Arthritis Patients incyte.com ↗
Results from the 50-patient placebo-controlled trial demonstrated that three of the four doses of INCB18424 evaluated (15 mg BID, 25 mg BID and 50 mg QD) produced impressive clinical benefits and all of the doses were well tolerated. |
| 2008-09-18 | Incyte Corporation | Results Incyte's Topical JAK Inhibitor Demonstrates Positive Proof-of-Concept Results in Patients with Mild to Moderate Psoriasis incyte.com ↗
Incyte Corporation (Nasdaq:INCY) reported positive results from two 28-day Phase IIa clinical trials of topical INCB18424, a selective janus-associated kinase (JAK) inhibitor, in patients with mild to moderate psoriasis. |
| 2008-06-02 | Incyte Corporation | Results Incyte's Novel JAK Inhibitor Demonstrates Rapid Clinical Benefits in Ongoing Phase I/II Myelofibrosis Study incyte.com ↗
Incyte Corporation (Nasdaq: INCY) announced today the presentation of clinical results from a Phase I/II study of INCB18424, its orally available janus-associated kinase (JAK) inhibitor, in patients with myelofibrosis. |
| 2008-01-08 | Incyte Corporation | Results Incyte to Report Positive Clinical Results from JAK Inhibitor and 11beta-HSD1 Inhibitor Programs and Introduce New Metabolic Program at JPMorgan Healthcare Conference incyte.com ↗
Three of four patients completing the 28-day study have achieved ACR50 criteria, two of whom also met ACR90 criteria, one within two weeks. |
| 2007-12-10 | Incyte Corporation | Results Data Presented At The American Society Of Hematology 49th Meeting Demonstrate That Incyte's Novel JAK Inhibitor, INCB18424, Provides Rapid and Profound Clinical Benefits in Myelofibrosis Patients incyte.com ↗
Incyte (Nasdaq:INCY) announced today the presentation of interim Phase I/II results of INCB18424, its orally available janus-associated kinase (JAK) inhibitor in patients with myelofibrosis (MF). |
| 2007-09-25 | Incyte Corporation | Results Incyte Reports Positive Proof-of-Concept Results For INCB18424, Its Lead JAK Inhibitor, and INCB13739, its Lead 11beta-HSD1 Inhibitor incyte.com ↗
Today, at the 2007 UBS Global Life Sciences Conference, Incyte Corporation (Nasdaq:INCY) will announce positive proof-of-concept clinical results from the following trials: |
| 2007-07-26 | Incyte Corporation | Results Incyte Cites Encouraging Clinical Data in Multiple Programs; Announces Second Quarter 2007 Financial Results incyte.com ↗
in addition, we have seen improvements in signs and symptoms in the limited number of MPD patients studied to date. |
All press releases naming this drug 194 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 194 releases opens the full record — a long page | ||
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 422 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ruxolitinib | “The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗406“Participants will receive any one of the following systemic BATs based on the Investigator's decision: mycophenolate mofetil (MMF), extracorporeal photopheresis (ECP),...” NCT04629833 ↗ “The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients.” NCT01644110 ↗ “Ruxolitinib is a Janus kinase 1/2 inhibitor that blocks signal transduction of interferon-gamma, a critical cytokine involved in the pathogenesis of cutaneous lichen planus (LP).” PMID 35131254 ↗ Feb 2022 “PD-1 monoclonal antibody is a new attempt treatment, and ruxolitinib and/or low-dose dexamethasone can reduce the inflammation that occur in EBV-HLH or CAEBV.” NCT05039580 ↗ “Patients with acute grade II GVHD are treated with a combination of methylprednisolone (0.5 mg/kg/day) and ruxolitinib.” NCT07576010 ↗ “Safety and efficacy of the combination of sonidegib and ruxolitinib in myelofibrosis: a phase 1b/2 dose-finding study.” PMID 32634234 ↗ Jul 2020 “2. Ruxolitinib, a JAK1/2 inhibitor that can reduce inflammation by interfering with immune signaling pathways.” NCT06951971 ↗ “extracorporeal photopheresis (ECP), anti-thymocyte globulin (ATG), etanercept, infliximab or ruxolitinib (RUX)” NCT06075706 ↗ “Treatment with Ruxolitinib at a dose of 10 mg BID orally addition to BAT according DGHO-Onkopedia guidelines” NCT02396628 ↗ “Ruxolitinib 10mg BID will be administered in combination with Fostamatinib in each of the study arms.” NCT06233110 ↗ |
| Known as | INC424 | “Ruxolitinib (INCB018424 phosphate, INC424, ruxolitinib phosphate) is a well established, potent and selective inhibitor of Janus kinase (JAK)1 and JAK2” NCT04359290 ↗9“The JAK1/2 kinase inhibitor Ruxolitinib (INC424) is approved for myelofibrosis.” NCT02396628 ↗ “the JAK Inhibitor Ruxolitinib (INC424)” NCT02087059 ↗ “RUXOLITINIB / INC 424” NCT02469974 ↗ “Ruxolitinib (INC424)” NCT02370706 ↗ “INC424 / Ruxolitinib” NCT04414098 ↗ |
| Known as | INCB018242 | “Phase II Study of Combination Ruxolitinib (INCB018242) With Preoperative Chemotherapy for Triple Negative Inflammatory Breast Cancer Following Completion of a Phase I...” NCT02041429 ↗ |
| Known as | INCB018424 | “A Pilot, Prospective, Randomized, Double-Blinded, Vehicle- and Comparator-Controlled Trial on Safety and Efficacy of a Topical Inhibitor of Janus Kinase 1/2 (Ruxolitinib...” NCT03954236 ↗4“Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients” NCT01340651 ↗ “Ruxolitinib (INCB018424)” NCT01594216 ↗ |
| Known as | INCB018424 phosphate | “Ruxolitinib (INCB018424 phosphate, INC424, ruxolitinib phosphate) is a well established, potent and selective inhibitor of Janus kinase (JAK)1 and JAK2” NCT04359290 ↗ |
| Known as | INCB018424 phosphate cream | “INCB018424 phosphate cream” NCT02809976 ↗1“INCB018424 Phosphate Cream” NCT06238817 ↗ |
| Known as | INCB18424 | “RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.” NCT01164163 ↗ |
| Known as | Jakafi | “Ruxolitinib (Jakafi) is approved by the FDA for the treatment of intermediate or high-risk myelofibrosis in adults, polycythemia vera in adults who have had an inadequate...” NCT05398809 ↗6“The primary objective of this research study is to determine the maximum tolerated dose (MTD) of Ruxolitinib (Jakafi) in combination with standard dose Bortezomib (Velcade) in...” NCT02613598 ↗ “The purpose of this study is to find out the effects of a study drug, ruxolitinib (also called Jakafi), in these patients.” NCT07085039 ↗ “Ruxolitinib (Jakafi/Jakavi) is FDA approved for myelofibrosis and was shown to reduce splenomegaly and improve symptoms.” NCT04281498 ↗ “Ruxolitinib (Jakafi) is an Food and Drug Administration (FDA) approved treatment for myelofibrosis” NCT02066532 ↗ “Ruxolitinib Oral Tablet [Jakafi] at 5mg, 10mg or 15mg BID” NCT03110822 ↗ |
| Known as | Jakavi | “The ReTreatment Trial: A Phase II, Open-label, Single-arm Study of Re-treating Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of...” NCT02091752 ↗10“Ruxolitinib (JAKAVI®) is currently approved in the European Union (EU) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (PMF)” NCT04359290 ↗ “Ruxolitinib (Jakafi/Jakavi) is FDA approved for myelofibrosis and was shown to reduce splenomegaly and improve symptoms.” NCT04281498 ↗ “IBM patients treated by ruxolitinib (JAKAVI®), 15mg per os, twice a day, during 12 months.” NCT06536166 ↗ “Ruxolitinib phosphate tablet（Jakavi,NOVARTIS,9104733)” NCT06909136 ↗ “Ruxolitinib (JAKAVI®) - Novartis. Tablets 5 mg.” NCT02962388 ↗ “Prednisone + Jakavi(ruxolitinib)” NCT06756061 ↗ “Drug: Ruxolitinib (JAKAVI®)” NCT07184853 ↗ “Ruxolitinib (JAKAVI®)” NCT07366801 ↗ “Ruxolitinib (JAKAVI®)” NCT06607367 ↗ “Ruxolitinib (JAKAVI®)” NCT07464951 ↗ |
| Known as | low-dose ruxolitinib | “low-dose ruxolitinib” NCT03165734 ↗ |
| Known as | OPZELURA | “OPZELURA (Ruxolitinib) Cream” NCT06673654 ↗ |
| Known as | Rux | “Functional small-molecule screening of primary acute myeloid leukemia (AML) samples identified ex vivo synergy between the JAK1/2 inhibitor, ruxolitinib (Rux), and venetoclax...” PMID 42007254 ↗ Feb 202611“Participants will receive any one of the following systemic BATs based on the Investigator's decision: mycophenolate mofetil (MMF), extracorporeal photopheresis (ECP),...” NCT04629833 ↗ “The FMF-02 is a multicenter, randomized, open-label, phase IIb clinical trial to compare the safety and effectiveness of FM and ruxolitinib phosphate (RUX) in patients with...” PMID 41883618 ↗ Mar 2026 “To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment...” PMID 41644167 ↗ Feb 2026 “Using a newly developed COVID-19 Inflammation Score (CIS), patients were prospectively stratified for targeted inhibition of cytokine signalling by the Janus Kinase 1/2...” PMID 32518419 ↗ Jun 2020 “Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD).” PMID 33957195 ↗ May 2021 “Ruxolitinib (RUX) was self-administered by the subject orally in the morning and evening, approximately 12 hours apart, without regard to food.” NCT01822756 ↗ “Ruxolitinib (RUX) is approved for second-line therapy in high-risk PV pts with hydroxyurea intolerance or resistance.” PMID 36564535 ↗ Dec 2022 “extracorporeal photopheresis (ECP), anti-thymocyte globulin (ATG), etanercept, infliximab or ruxolitinib (RUX)” NCT06075706 ↗ “20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)” NCT04456634 ↗ “ruxolitinib (RUX, 5 mg/day) with corticosteroids” PMID 39438467 ↗ Oct 2024 |
| Known as | Ruxo | “Ruxolitinib(Ruxo): body weight (BW)\<10kg: 2.5mg Bid; 10-20kg: 5mg Bid; \>20kg: 10mg Bid; Orally for 4 weeks.” NCT05491304 ↗ |
| Known as | Ruxolitinib cream | “Ruxolitinib cream, a Janus kinase (JAK) inhibitor, is effective and well tolerated in adolescents and adults with AD.” PMID 36586583 ↗ Dec 2022 |
| Known as | ruxolitinib phosphate | “The FMF-02 is a multicenter, randomized, open-label, phase IIb clinical trial to compare the safety and effectiveness of FM and ruxolitinib phosphate (RUX) in patients with...” PMID 41883618 ↗ Mar 202611“Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).” NCT07356245 ↗ “Ruxolitinib (INCB018424 phosphate, INC424, ruxolitinib phosphate) is a well established, potent and selective inhibitor of Janus kinase (JAK)1 and JAK2” NCT04359290 ↗ “Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia” NCT02092324 ↗ “20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)” NCT04456634 ↗ “Pelabresib monohydrate tablets + ruxolitinib phosphate tablets” NCT04603495 ↗ “Ruxolitinib phosphate tablets 5 mg administered as oral doses.” NCT00952289 ↗ “Ruxolitinib phosphate blocks a protein called janus kinase” NCT07278856 ↗ “ruxolitinib (ruxolitinib phosphate)” NCT02528877 ↗ “ruxolitinib (ruxolitinib phosphate)” NCT01732445 ↗ “Drug: Ruxolitinib Phosphate” NCT03041636 ↗ |
| Known as | Ruxolitinib, Jakafi | “Ruxolitinib, Jakafi” NCT06209606 ↗ |
| Known as | Ruxolitinib, Jakavi | “Ruxolitinib, Jakavi” NCT03110822 ↗ |
| Known as | Topical Ruxolitinib (INCB18424) | “Topical Ruxolitinib (INCB18424)” NCT06399029 ↗ |
| Action | Inhibit | “a small molecule Janus kinase 2 (JAK2)-inhibitor” NCT00639002 ↗ |
| Modality | Small molecule | “ruxolitinib, a small molecule Janus kinase (JAK) inhibitor” NCT00509899 ↗ |
| Route | Oral | “15 mg po bid” NCT00044304 ↗ |
| Target | JAK2 | “a small molecule Janus kinase 2 (JAK2)-inhibitor” NCT00639002 ↗ |