Drugs / Itacitinib
Itacitinib
also known as
INCB039110 · itacitinib (INCB039110) · INCB-039110 ADIPATE · Incb-39110 · Itacitinib Adipate
Small molecule targets IL6, JAK1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic graft versus host disease | 2021-02-09 | “Steroid-refractory chronic GVHD2: sNDA submitted itacitinib (JAK1)” incyte.com ↗ |
Trials 53
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT05823571 | Jul 2023 → Mar 2028 expected | T-cell prolymphocytic leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome +2 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04239989 | Oct 2021 → Oct 2025 | bronchiolitis obliterans syndrome | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT04070781 | Jan 2020 → Dec 2021 | graft versus host disease | Columbia University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03989466 | Jan 2020 → Sep 2024 | T-cell prolymphocytic leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03670069 | Sep 2019 → Mar 2023 | chondrosarcoma, leiomyosarcoma, myxoid liposarcoma, round cell liposarcoma +2 | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03755414 | Sep 2019 → Apr 2024 | Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03272464 | May → Jul 2019 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04358185 | Dec 2018 → Apr 2023 | hepatocellular carcinoma | Imperial College London | Completed | No outcome recorded |
| Phase 1 | NCT03497273 | Mar 2018 → Nov 2019 | acute graft versus host disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03320642 | Feb 2018 → Feb 2021 | hematopoietic and lymphoid cell neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT02646748 | Jan 2016 → Nov 2019 | breast cancer, colorectal cancer, endometrial cancer, head and neck cancer +5 | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02614612 | Dec 2015 → Jun 2016 | acute graft versus host disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02559492 | Nov 2015 → Sep 2018 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT01905813 | Jun 2013 → Feb 2026 | B-cell neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/29 trials | ||||||
| Phase 1/2 | NCT04061421 | Nov 2021 → Aug 2027 expected | myelodysplastic/myeloproliferative neoplasm | Michael Savona | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04220632 | Jun → Oct 2020 | acute graft versus host disease | Innovent Biologics (Suzhou) Co. Ltd. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03978637 | Feb 2020 → Oct 2023 | bronchiolitis obliterans syndrome | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03721965 | Dec 2019 → Feb 2020 | acute graft versus host disease | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT03697408 | Feb 2019 → May 2024 overdue | classic Hodgkin lymphoma | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02760485 | Dec 2016 → Jun 2022 | large B-cell lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02917993 | Dec 2016 → Dec 2025 | lung cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02018861 | Sep 2016 → Apr 2021 | B-cell neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT01858883 | Jun 2013 → Feb 2016 | malignant pancreatic neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 226 trials · 2 met primary | ||||||
| Phase 2 | NCT05757219 | May 2023 → Feb 2027 expected | diffuse large B-cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05660421 | Mar 2023 → Apr 2025 | cancer, hematopoietic and lymphoid cell neoplasm | Douglas Johnson | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04789850 | Feb 2023 → Feb 2026 overdue | systemic sclerosis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT05364762 | Nov 2022 → Mar 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome +2 | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05063110 | May 2022 → Apr 2025 | hemophagocytic syndrome | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT04859946 | Jan 2022 → Apr 2027 expected | hematologic disorder | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04629508 | Jul 2021 → Aug 2023 | acquired polycythemia vera, myelofibrosis, thrombocytosis disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04640025 | Mar 2021 → May 2026 | chronic graft versus host disease, myelofibrosis, transplant-related bronchiolitis obliterans | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT04446182 | Jan 2021 → Mar 2022 | chronic graft versus host disease | University of Utah | Terminated | No outcome recorded |
| Phase 2 | NCT04339101 | Nov 2020 → May 2023 | acute leukemia, myelodysplastic syndrome, myelofibrosis, primary myelofibrosis | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04127721 | Sep 2020 | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04509700 | Aug 2020 → Nov 2026 expected | B-cell neoplasm | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04200365 | Jun 2020 → Sep 2023 | chronic graft versus host disease | SCRI Development Innovations, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04071366 | Feb 2020 → Feb 2023 | cytokine release syndrome | Incyte Corporation | Completed | Met primary |
| Phase 2 | NCT03846479 | Mar 2019 → May 2021 | acute graft versus host disease | John Levine | Completed | No outcome recorded |
| Phase 2 | NCT03627052 | Sep 2018 → Nov 2019 | ulcerative colitis | Incyte Corporation | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02909569 | Aug → Oct 2018 | — | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT03425006 | Jun 2018 → Jun 2021 | non-small cell lung carcinoma | University of Pennsylvania | Terminated | No outcome recorded |
| Phase 2 | NCT03144687 | Jan 2018 → Mar 2020 | myeloproliferative neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02456675 | Jun 2015 → Dec 2016 | Hodgkins lymphoma | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT02355431 | Dec 2014 → Sep 2015 | hematopoietic and lymphoid cell neoplasm, non-small cell lung carcinoma | Incyte Corporation | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02257619 | Sep 2014 → Feb 2016 | non-small cell lung carcinoma | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01633372 | Jul 2012 → Dec 2013 | myeloproliferative neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01634087 | Jun 2012 → Jan 2013 | psoriasis | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01626573 | Mar 2012 → Jul 2013 | rheumatoid arthritis | Incyte Corporation | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03584516 | Jan 2019 → Nov 2023 | chronic graft versus host disease | Incyte Corporation | Terminated | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03139604 | Jul 2017 → May 2019 | acute graft versus host disease | Incyte Corporation | Completed | Missed primary |
| Phase not stated2 trials | ||||||
| — | NCT03906318 | — | aplastic anemia | Incyte Corporation | No longer available | No outcome recorded |
| — | NCT05561985 | — | — | Incyte Corporation | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT02265510 Background | Sep 2014 → Feb 2019 | metastatic malignant neoplasm | Incyte Corporation | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-01-02 | Incyte Corporation | Results Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease incyte.com ↗
Itacitinib added to corticosteroids improved the overall response rate in patients with treatment-naïve acute GVHD; however, the difference versus placebo plus corticosteroids was not statistically significant. |
| 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 ↗
Phillips, TJ et al; Interim analysis of a Phase 1 study of INCB040093, a PI3Kδ inhibitor, alone or in combination with INCB039110, a selective JAK1 inhibitor, in patients with relapsed or refractory B-cell malignancies. |
| 2013-10-28 | Incyte Corporation | Results Positive Results Presented from Proof-of-Concept Phase II Clinical Trial of Incyte’s Oral JAK1 Inhibitor in Patients with Active Rheumatoid Arthritis incyte.com ↗
Incyte Corporation (Nasdaq: INCY) announced results from a 12-week, placebo-controlled, dose-escalation Phase II proof-of-concept clinical trial involving 60 patients with active rheumatoid arthritis for its proprietary oral JAK1 inhibitor. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-01-02 | Incyte Corporation | Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease incyte.com ↗ |
| 2019-01-22 | Incyte Corporation | Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease incyte.com ↗ |
| 2017-07-20 | Incyte Corporation | Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft-Versus-Host Disease incyte.com ↗ |
| 2015-05-27 | Incyte Corporation | Incyte Clinical Portfolio to be Featured in 23 Abstract Presentations at the 2015 ASCO and EHA Annual Meetings incyte.com ↗ |
| 2013-10-28 | Incyte Corporation | Positive Results Presented from Proof-of-Concept Phase II Clinical Trial of Incyte’s Oral JAK1 Inhibitor in Patients with Active Rheumatoid Arthritis incyte.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ITACITINIB | “This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs).” NCT05063110 ↗51“Treatment with the JAK1 inhibitor itacitinib resulted in a rapid resolution of aplastic anemia” PMID 35590143 ↗ Jan 2022 |
| Known as | INCB-039110 ADIPATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622820 ↗ |
| Known as | Incb-39110 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622820 ↗ |
| Known as | INCB039110 | “Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression” NCT05823571 ↗5“Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.” NCT02559492 ↗ “itacitinib (formerly INCB039110), a selective JAK1 inhibitor” PMID 29695516 ↗ Apr 2018 |
| Known as | itacitinib (INCB039110) | “itacitinib (INCB039110)” NCT02018861 ↗1“itacitinib (INCB039110)” NCT01905813 ↗ |
| Known as | Itacitinib Adipate | “Drug: Itacitinib Adipate” NCT04339101 ↗ |
| Action | Inhibit | “a potent and selective oral JAK1 inhibitor” PMID 27789678 ↗ Oct 2016 |
| Modality | Small molecule | “a JAK 1 selective small molecule inhibitor” NCT03425006 ↗ |
| Route | Oral | “a potent and selective oral JAK1 inhibitor” PMID 27789678 ↗ Oct 2016 |
| Target | JAK1 | “a potent and selective oral JAK1 inhibitor” PMID 27789678 ↗ Oct 2016 |