Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NINLARO | — | 2022-04-28 | fda.gov ↗ |
| Approved | EU (EMA) | Ninlaro | — | 2016-11-21 | europa.eu ↗ |
| Approved | US (FDA) | NINLARO | — | 2015-11-20 | fda.gov ↗ |
Trials 138 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT02921893 | Oct 2016 → Apr 2022 | POEMS syndrome, plasmacytoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT02630030 | Mar 2016 → Jul 2018 | glioblastoma | Emory University | Completed | No outcome recorded |
| Phase 129 trials | ||||||
| Phase 1 | NCT04847453 | Aug 2022 → Jun 2028 expected | AL amyloidosis | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03880123 | Nov 2020 | Ewing sarcoma, alveolar soft part sarcoma, liposarcoma, malignant peripheral nerve sheath tumor | Matthew Ingham | Withdrawn | No outcome recorded |
| Phase 1 | NCT03888534 | Oct 2020 → Aug 2022 | precursor lymphoblastic lymphoma/leukemia | Millennium Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT03783416 | Jun 2020 → Jul 2026 overdue | primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 1 | NCT03770260 | Feb 2020 → Sep 2022 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT03283917 | Feb 2018 → Jun 2026 | AL amyloidosis | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02578511 | Jun 2017 → Feb 2018 | acute lymphoblastic leukemia, lymphoblastic lymphoma, mixed phenotype acute leukemia | Ehab L Atallah | Withdrawn | No outcome recorded |
| Phase 1 | NCT02942095 | Mar 2017 → Dec 2022 | cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03422874 | Aug 2016 → Aug 2017 | lymphoma | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT02697383 | Feb 2016 → May 2024 | smoldering plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02582359 | Jan 2016 → Apr 2022 | acute myeloid leukemia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02504359 | Jul 2015 → Sep 2020 | plasma cell leukemia, plasma cell myeloma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02384746 | Jun 2015 → Apr 2018 | breast cancer | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT02228772 | Dec 2014 → Oct 2016 | B-cell adult acute lymphocytic leukemia, T-cell adult acute lymphocytic leukemia, lymphoblastic lymphoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02070458 | Oct 2014 → Mar 2017 | acute myeloid leukemia | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02042989 | Jun 2014 → Jan 2020 | high grade malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02176486 | Jun 2014 → Mar 2017 | lupus nephritis | Takeda | Terminated | No outcome recorded |
| Phase 1 | NCT01953783 | Mar → Dec 2014 | cancer, lymphoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01830816 | Sep 2013 → Mar 2015 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01912222 | Aug 2013 → Mar 2015 | cancer, hematopoietic and lymphoid cell neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01887587 | Jun 2013 → Feb 2016 | adult acute lymphoblastic leukemia, mixed phenotype acute leukemia | Ehab L Atallah | Terminated | No outcome recorded |
| Phase 1 | NCT01645930 | Dec 2012 → Jul 2014 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04272775 | Jun 2012 → Feb 2019 | refractory plasma cell neoplasm | Takeda | Terminated | No outcome recorded |
| Phase 1 | NCT01454076 | Nov 2011 → Apr 2015 | lymphoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01318902 | Apr 2011 → Nov 2018 | AL amyloidosis | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00932698 | Oct 2009 → Jun 2013 | refractory plasma cell neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00963820 | Oct 2009 → Sep 2012 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00893464 | Aug 2009 → Oct 2014 | lymphoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00830869 | Mar 2009 → Apr 2012 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/227 trials | ||||||
| Phase 1/2 | NCT06050512 | Oct 2023 → Oct 2026 | refractory plasma cell neoplasm | Kathleen Dorritie | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04079738 | Sep 2019 → Sep 2021 | acute myeloid leukemia | H Scott Boswell | Terminated | No outcome recorded |
| Phase 1/2 | NCT04094961 | Sep 2019 → Jun 2025 overdue | plasma cell myeloma | Omar Nadeem, MD | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03817320 | Feb 2019 → Dec 2023 overdue | childhood acute lymphoblastic leukemia | Therapeutic Advances in Childhood Leukemia Consortium | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03547700 | Sep 2018 → Aug 2020 | peripheral T-cell lymphoma, not otherwise specified | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03323151 | Aug 2018 → Sep 2022 | mantle cell lymphoma | PrECOG, LLC. | Completed | No outcome recorded |
| Phase 1/2 | NCT03492138 | Mar 2018 → Jan 2020 | plasma cell myeloma | Ajai Chari | Terminated | No outcome recorded |
| Phase 1/2 | NCT03236792 | Jun 2017 → Sep 2022 | AL amyloidosis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1/2 | NCT03225417 | May 2017 → Jan 2024 overdue | disease related to hematopoietic stem cell transplant, plasma cell myeloma | Andalusian Public Foundation for Health Research in Seville | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02946047 | Mar 2017 → Aug 2019 | HIV infectious disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT02898259 | Feb 2017 → Oct 2018 | indolent B-cell non-Hodgkin lymphoma | Brian Hill | Terminated | No outcome recorded |
| Phase 1/2 | NCT02993094 | Nov 2016 → Aug 2020 | triple-negative breast carcinoma | Study Group of Medical Tumour Therapy (AGMT) | Terminated | No outcome recorded |
| Phase 1/2 | NCT02632396 | Mar 2016 → Aug 2023 | mantle cell lymphoma | Emory University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02633059 | Dec 2015 → Jan 2021 | chromosome 17p deletion, plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT02481310 | Oct 2015 → Sep 2020 | Burkitt lymphoma, plasmablastic lymphoma | Northwestern University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02343042 | Oct 2015 → Apr 2027 expected | plasma cell myeloma | Karyopharm Therapeutics Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02542657 | Oct 2015 → Aug 2025 overdue | plasma cell myeloma | Joseph Tuscano | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02447887 | Aug 2015 → Apr 2017 | renal cell carcinoma | Fox Chase Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02420847 | Jul 2015 → Dec 2025 overdue | urothelial carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02250300 | Nov 2014 → Oct 2020 | disease related to hematopoietic stem cell transplant | Mehdi Hamadani | Completed | No outcome recorded |
| Phase 1/2 | NCT02119468 | Jun 2014 → May 2016 | plasma cell myeloma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02057640 | May 2014 → May 2018 | plasma cell myeloma | Jason Valent | Completed | No outcome recorded |
| Phase 1/2 | NCT02004275 | Feb 2014 → Dec 2021 | plasma cell myeloma | Alliance for Clinical Trials in Oncology | Unknown | No outcome recorded |
| Phase 1/2 | NCT01864018 | Aug 2013 → Apr 2021 | amyloidosis, plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT01383928 | Oct 2011 → Oct 2014 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01335685 | Jun 2011 → Dec 2016 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01217957 | Nov 2010 → Mar 2013 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 263 trials | ||||||
| Phase 2 | NCT06744894 | Jan 2025 → Jan 2028 expected | plasma cell myeloma | Navy General Hospital, Beijing | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04305691 | Nov 2023 → Mar 2029 expected | Kaposi's sarcoma | AIDS Malignancy Consortium | Recruiting | No outcome recorded |
| Phase 2 | NCT04998786 | Dec 2021 → Jan 2030 expected | plasma cell myeloma | Nantes University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04837131 | Apr 2021 → Feb 2024 | diffuse cutaneous systemic sclerosis, diffuse scleroderma, interstitial lung disease, pulmonary systemic sclerosis | Michael M. Pham | Terminated | No outcome recorded |
| Phase 2 | NCT04790474 | Mar 2021 → Mar 2026 overdue | plasma cell myeloma | Tel-Aviv Sourasky Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04009109 | Oct 2020 → Dec 2026 expected | plasma cell myeloma | Alliance Foundation Trials, LLC. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04463953 | Jun 2020 → Dec 2022 | Waldenstrom macroglobulinemia | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 2 | NCT04119336 | Feb → Nov 2020 | plasma cell myeloma | Andrew Yee, MD | Terminated | No outcome recorded |
| Phase 2 | NCT03683277 | Nov 2019 → Dec 2022 | disease of genetic or genomic mechanism, plasma cell myeloma, refractory plasma cell neoplasm | Intergroupe Francophone du Myelome | Terminated | No outcome recorded |
| Phase 2 | NCT04028115 | Oct 2019 → Apr 2024 | plasma cell myeloma | Thomas Lund | Completed | No outcome recorded |
| Phase 2 | NCT04052880 | Oct 2019 → May 2025 overdue | plasma cell myeloma | Larysa Sanchez | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03608501 | Sep 2019 → Jun 2021 | plasma cell myeloma | Takeda | Withdrawn | No outcome recorded |
| Phase 2 | NCT03965624 | Sep 2019 → Mar 2023 | autoimmune hemolytic anemia, warm type, autoimmune thrombocytopenia | Assistance Publique - Hôpitaux de Paris | Withdrawn | No outcome recorded |
| Phase 2 | NCT04047797 | Aug 2019 → Jun 2024 | mantle cell lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03942224 | Jul 2019 → Jul 2025 overdue | plasma cell myeloma | Emory University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03733691 | Mar 2019 → Oct 2023 | plasma cell myeloma | Oncotherapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT03757221 | Feb 2019 → Sep 2022 | plasma cell myeloma | University Hospital, Caen | Terminated | No outcome recorded |
| Phase 2 | NCT03763162 | Jan 2019 → Oct 2027 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03669445 | Dec 2018 → Mar 2024 | plasma cell myeloma | University Hospital, Toulouse | Unknown | No outcome recorded |
| Phase 2 | NCT03616782 | Dec 2018 → May 2026 | mantle cell lymphoma | Ho Sup Lee | Unknown | No outcome recorded |
| Phase 2 | NCT03590652 | Oct 2018 → Jul 2025 | refractory plasma cell neoplasm | University of California, San Diego | Terminated | No outcome recorded |
| Phase 2 | NCT03731832 | Sep 2018 → Apr 2024 | plasma cell myeloma | GWT-TUD GmbH | Completed | No outcome recorded |
| Phase 2 | NCT03457142 | Sep 2018 → Nov 2022 | plasma cell myeloma | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03587662 | Aug 2018 → Jan 2027 expected | kidney medullary carcinoma, renal cell adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03506373 | Aug 2018 → Feb 2023 | Waldenstrom macroglobulinemia | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2 | NCT03618537 | Aug 2018 → Aug 2026 overdue | AL amyloidosis | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03376672 | May 2018 → Dec 2027 expected | plasma cell myeloma | Raija Silvennoinen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03439293 | Mar 2018 → Jan 2022 | plasma cell myeloma | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT03213158 | Sep 2017 → Apr 2021 | end stage renal failure | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 2 | NCT03170882 | Aug 2017 → Aug 2020 | refractory plasma cell neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03202628 | Jul 2017 → Apr 2021 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03012880 | Apr 2017 → Dec 2022 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03082677 | Mar 2017 → Sep 2021 | lymphoid neoplasm, myeloid neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02924272 | Dec 2016 → Jul 2024 | amyloidosis, plasma cell myeloma | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT02917941 | Nov 2016 → Aug 2019 | refractory plasma cell neoplasm | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT02916771 | Oct 2016 → Jan 2025 | smoldering plasma cell myeloma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02765854 | Sep 2016 → May 2023 | plasma cell myeloma | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT02897830 | Aug 2016 → Nov 2018 | plasma cell myeloma | University Hospital, Toulouse | Terminated | No outcome recorded |
| Phase 2 | NCT02339922 | May 2016 → Dec 2024 overdue | MALT lymphoma, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma +1 | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02619682 | Dec 2015 → Jun 2022 | carcinoma, plasma cell myeloma | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02547662 | Dec 2015 → Oct 2020 | plasma cell leukemia, plasma cell myeloma, plasmacytoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT02513498 | Dec 2015 → Jan 2018 | chronic graft versus host disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02578121 | Dec 2015 → Jan 2017 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded |
| Phase 2 | NCT02461888 | Dec 2015 → Apr 2022 | plasma cell myeloma | University of Leeds | Completed | No outcome recorded |
| Phase 2 | NCT02586038 | Oct 2015 → Oct 2023 | plasma cell myeloma | Mario Boccadoro | Completed | No outcome recorded |
| Phase 2 | NCT02499081 | Sep 2015 → May 2018 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT02440464 | Aug 2015 → Oct 2020 | plasma cell myeloma | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT02412228 | Aug 2015 → Mar 2019 | plasma cell myeloma | John L. Reagan | Completed | No outcome recorded |
| Phase 2 | NCT02400437 | Apr 2015 → Nov 2019 | Waldenstrom macroglobulinemia | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02410694 | Apr 2015 → Mar 2019 | plasma cell myeloma | Study Group of Medical Tumour Therapy (AGMT) | Completed | No outcome recorded |
| Phase 2 | NCT02302846 | Mar 2015 → May 2017 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02389517 | Mar 2015 → Feb 2021 | plasma cell myeloma | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT02253316 | Jan 2015 → Feb 2020 overdue | plasma cell myeloma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01936532 | Nov 2014 → Mar 2019 | plasma cell myeloma | Nantes University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02158975 | Sep 2014 → Oct 2016 | T-cell non-Hodgkin lymphoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02168101 | Sep 2014 → Feb 2019 | plasma cell myeloma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02169791 | Jul 2014 → Jul 2020 | acute leukemia, chronic leukemia, myelodysplastic syndrome, plasma cell myeloma | Northside Hospital, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02046070 | Mar 2014 → Jun 2018 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02030405 | Mar 2014 → Nov 2015 | acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +7 | Steven E. Coutre | Terminated | No outcome recorded |
| Phase 2 | NCT01939899 | Oct 2013 → Jun 2016 | follicular lymphoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01718743 | Dec 2012 → Apr 2023 | disease related to hematopoietic stem cell transplant, plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01660997 | Jul 2012 → Mar 2014 | plasma cell myeloma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT01415882 | Jan 2012 → Apr 2023 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT03941860 | Feb 2022 → Aug 2023 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT03651128 | Apr 2019 → Apr 2026 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03748953 | Jan 2019 → Dec 2023 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03562169 | Mar 2017 → Mar 2026 overdue | plasma cell myeloma | University of Leeds | Recruiting | No outcome recorded |
| Phase 3 | NCT02516423 | Nov 2016 → Sep 2024 | solitary osseous plasmacytoma | Alliance for Clinical Trials in Oncology | Terminated | No outcome recorded |
| Phase 3 | NCT02312258 | Apr 2015 → Aug 2019 | plasma cell myeloma | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02406144 | Nov 2014 → Sep 2017 | plasma cell myeloma | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 3 | NCT02181413 | Jul 2014 → Apr 2018 | disease related to hematopoietic stem cell transplant, plasma cell myeloma | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01659658 | Dec 2012 → Jul 2022 | AL amyloidosis | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01564537 | Aug 2012 → Oct 2014 | plasma cell myeloma | Takeda | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT05722405 | Jul 2022 → Jun 2026 overdue | plasma cell myeloma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 4 | NCT05183139 | Jun 2022 → Dec 2026 | plasma cell myeloma | Takeda | Withdrawn | No outcome recorded |
| Phase 4 | NCT04989140 | Jul 2021 → Jul 2024 | plasma cell myeloma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04217967 | Sep 2019 → Jun 2024 | plasma cell myeloma | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03416374 | Feb 2018 → May 2021 | refractory plasma cell neoplasm | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03173092 | Nov 2017 → Mar 2026 | plasma cell myeloma | Takeda | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05477797 | Feb 2023 → Jan 2026 | — | RenJi Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04405167 Background | Jul 2020 → May 2025 | plasma cell myeloma | University of Pennsylvania | Terminated | No outcome recorded |
| Phase 1 | NCT03399539 Background | May 2018 → Dec 2021 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT02831686 Background | Jul 2016 → Nov 2020 | plasma cell myeloma, refractory plasma cell neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT05451771 Comparator | Oct 2022 → Sep 2027 expected | AL amyloidosis | Columbia University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04068597 Background | Aug 2019 → Mar 2027 expected | T-cell non-Hodgkin lymphoma, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma | CellCentric Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03856112 Background | Jun 2019 → Dec 2021 | plasma cell myeloma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03732703 Background | Apr 2019 → Dec 2024 | refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT02477215 Background | Oct 2015 → May 2018 | plasma cell myeloma | Parameswaran Hari | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03746652 Background | Dec 2018 → Dec 2021 | plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 2 | NCT03506360 Background | Jun 2018 → Nov 2019 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05675319 Comparator | Mar 2023 → Mar 2025 | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded |
| Phase 3 | NCT03720041 Comparator | Aug 2020 → Dec 2024 | plasma cell myeloma | University of Leeds | Unknown | No outcome recorded |
| Phase 3 | NCT01850524 Comparator | Apr 2013 → Dec 2019 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04008888 Background | Jan 2018 → Jan 2020 | chromosome 17p deletion, extramedullary soft tissue plasmacytoma, plasma cell leukemia, plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
Press releases naming this drug 29 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-09 | Takeda | Takeda Announces Results from Phase 3 Clinical Trial Evaluating NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma takeda.com ↗ |
| 2020-06-12 | Takeda | Takeda Presents Positive Data from Clinical Trial Evaluating Oral NINLARO™ (ixazomib) in Multiple Myeloma as a First-Line Maintenance Therapy takeda.com ↗ |
| 2019-12-07 | Takeda | Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis takeda.com ↗ |
| 2019-11-07 | Takeda | Phase 3 Trial of NINLARO TM (ixazomib) as First Line Maintenance Therapy Met Primary Endpoint in Multiple Myeloma Patients not treated with Stem Cell Transplantation takeda.com ↗ |
| 2018-07-11 | Takeda | Phase 3 Trial of NINLARO ® (ixazomib) as Maintenance Therapy Met Primary Endpoint Demonstrating Statistically Significant Improvement in Progression-Free Survival in Patients with Multiple Myeloma Post-Transplant takeda.com ↗ |
| 2017-06-23 | Takeda | Takeda Presents Data from Phase 1/2 Studies for NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma Patients and in the Maintenance Setting takeda.com ↗ |
| 2017-05-24 | Takeda | NINLARO ® Capsules Now Available for the Treatment of Multiple Myeloma in Japan takeda.com ↗ |
| 2017-03-30 | Takeda | Takeda Obtains New Drug Application Approval for NINLARO ® Capsules for the Treatment of Multiple Myeloma in Japan takeda.com ↗ |
| 2016-11-24 | Takeda | NINLARO TM (ixazomib) Receives Conditional Approval from the European Commission to Treat Multiple Myeloma takeda.com ↗ |
| 2016-09-16 | Takeda | Takeda Receives Positive CHMP Opinion for Conditional Approval of NINLARO (ixazomib), the First Oral Proteasome Inhibitor, for Use in Patients with Multiple Myeloma takeda.com ↗ |
| 2016-08-08 | Takeda | Takeda Receives Marketing Authorization in Canada for NINLARO™ (ixazomib) in Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2016-07-04 | Takeda | Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan takeda.com ↗ |
| 2016-05-27 | Takeda | Takeda Provides Update on EU Marketing Authorization Application for NINLARO® (ixazomib) in Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2016-04-28 | Takeda | Phase 3 Trial Results for First Oral Proteasome Inhibitor NINLARO (ixazomib) Published in The New England Journal of Medicine takeda.com ↗ |
| 2016-02-26 | Takeda | Japanese MHLW Grants Orphan Drug Designation in Japan to Takeda's Oral Proteasome Inhibitor Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-12-12 | Takeda | NINLARO® (ixazomib) Now Available for Patients takeda.com ↗ |
| 2015-12-07 | Takeda | Takeda Presents Data from Phase 3 TOURMALINE-MM1 Study for NINLARO® (ixazomib), First and Only Once-Weekly Oral Proteasome Inhibitor Recently Approved for Multiple Myeloma takeda.com ↗ |
| 2015-11-21 | Takeda | U.S. FDA Approves Takeda's NINLARO® (ixazomib), the First and Only Oral Proteasome Inhibitor to Treat Multiple Myeloma takeda.com ↗ |
| 2015-11-06 | Takeda | Takeda to Present Data from Ixazomib's Phase 3 Study in Relapsed/Refractory Multiple Myeloma at Upcoming American Society of Hematology Annual Meeting takeda.com ↗ |
| 2015-09-24 | Takeda | Takeda to Highlight Ixazomib Clinical Development Program at Upcoming International Myeloma Workshop takeda.com ↗ |
| 2015-09-09 | Takeda | U.S. FDA Grants Priority Review to Takeda's Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-08-21 | Takeda | Takeda Announces European Medicines Agency Acceptance of Ixazomib's Marketing Authorization Application for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-07-27 | Takeda | European Medicines Agency Grants Accelerated Assessment of Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-07-15 | Takeda | Takeda Submits New Drug Application for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-05-12 | Takeda | Takeda Announces First Patient Enrolled in Global Phase 3 Study of Ixazomib as Maintenance Therapy for Newly Diagnosed Multiple Myeloma takeda.com ↗ |
| 2015-02-10 | Takeda | Takeda Announces That the First Interim Analysis of the Phase 3 Study of Oral Ixazomib in Patients with Relapsed or Refractory Multiple Myeloma Met the Primary Endpoint of Improvement in Progression-Free Survival takeda.com ↗ |
| 2014-12-08 | Takeda | Takeda Presents Phase 2 Data on Maintenance with Single-Agent Investigational Ixazomib in Patients with Newly Diagnosed Multiple Myeloma takeda.com ↗ |
| 2014-12-02 | Takeda | Takeda's Investigational, Oral Proteasome Inhibitor Ixazomib Granted Breakthrough Therapy Designation by U.S. FDA for Relapsed or Refractory Systemic Light-chain Amyloidosis takeda.com ↗ |
| 2014-11-07 | Takeda | Takeda Announces Abstracts for ADCETRIS ® (brentuximab vedotin) in Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma and Ixazomib in Multiple Myeloma to be Presented at 56th American Society of Hematology Annual Meeting takeda.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 156 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ixazomib | “Oral ixazomib will be given on days 1, 8, 15 of a 28-day cycle, the investigator will start with first test dose levels of ixazomib of 3 mg and process with dose escalation, in...” NCT03965624 ↗130“Open-label, Single-center Phase II Study of MLN9708 (Ixazomib) in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas” NCT02158975 ↗ “Ixazomib is an oral, second-generation, proteasome inhibitor that has been shown in preclinical models to prevent GVHD.” PMID 32653622 ↗ Jul 2020 “Lenalidomide and dexamethasone maintenance with or without ixazomib, tailored by residual disease status in myeloma.” PMID 37506339 ↗ Nov 2023 “MLN9708 (ixazomib) administered on a day 1,8,15 every 28 day schedule up to 4mg” NCT02057640 ↗ “IRd chemotherapy with ixazomib, lenalidomide, and dexamethasone” NCT04405167 ↗ “Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)” NCT04008888 ↗ |
| Known as | IXA | “Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd)” NCT03651128 ↗ |
| Known as | Ixazomib Citrate | “The present study investigated 3 patients with recurrent glioblastoma after administration of oral ixazomib citrate (MLN 9708) at a fixed 4.0 mg dose within a 3-hpreoperative window.” PMID 32874573 ↗ Aug 202022“Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21.” NCT02119468 ↗ “Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia” NCT03506373 ↗ “The investigational drug being tested in this study is called ixazomib citrate.” NCT02181413 ↗ “ixazomib (ixazomib citrate) treatment for chronic graft-versus-host disease” NCT02513498 ↗ “The drug being tested in this study is called ixazomib citrate (MLN9708).” NCT00963820 ↗ “The drug being tested in this study is called ixazomib citrate.” NCT02312258 ↗ “ixazomib citrate (ixazomib)” NCT01864018 ↗ “ixazomib (ixazomib citrate)” NCT02481310 ↗ “MLN9708 (ixazomib citrate)” NCT04847453 ↗ “Drug: Ixazomib Citrate” NCT01718743 ↗ “Drug: Ixazomib Citrate” NCT03856112 ↗ “Drug: Ixazomib Citrate” NCT02504359 ↗ “Drug: Ixazomib Citrate” NCT02542657 ↗ “Drug: Ixazomib Citrate” NCT03770260 ↗ |
| Known as | IXZ | “Patients in the treatment arm received 4 mg of ixazomib (IXZ) every 28 days from day +100.” PMID 40737543 ↗ Nov 2025 |
| Known as | Millennium 9708 | “This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in combination with standard therapy for acute myeloid leukemia (AML) consisting of...” NCT02582359 ↗ |
| Known as | MLN | “This study is a phase 1/2 study to assess safety and hematologic response rate of Ixazomib (MLN) in combination with Cyclophosphamide (CTX) and Dexamethasone (DEX).” NCT03236792 ↗ |
| Known as | MLN9078 | “maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally” NCT01318902 ↗ |
| Known as | MLN9708 | “The primary objective is to determine the maximum-tolerated dose of IXAZOMIB (MLN9708) (maximum of 4 mg, which is the recommended phase II dose for IXAZOMIB (MLN9708) in...” NCT02578511 ↗25“A Phase 1 Study of Oral IXAZOMIB (MLN9708) to Assess Relative Bioavailability, Food Effect, Drug-Drug Interaction With Ketoconazole, Clarithromycin or Rifampin; and Safety and...” NCT01454076 ↗ “The present study investigated 3 patients with recurrent glioblastoma after administration of oral ixazomib citrate (MLN 9708) at a fixed 4.0 mg dose within a 3-hpreoperative window.” PMID 32874573 ↗ Aug 2020 “A Phase 1 Pharmacokinetic Study of Oral IXAZOMIB (MLN9708) in Patients With Advanced Solid Tumors or Hematologic Malignancies With Varying Degrees of Liver Dysfunction” NCT01912222 ↗ “An Open-Label, Dose-Escalation, Phase 1 Study of IXAZOMIB (MLN9708), A Second-Generation Proteasome Inhibitor, in Adult Patients With Lymphoma” NCT00893464 ↗ “Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed” NCT01383928 ↗ “An Open-Label, Dose Escalation, Phase 1 Study of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor” NCT00830869 ↗ “Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15” NCT01936532 ↗ “The drug tested in this study was called ixazomib (MLN9708).” NCT01335685 ↗ “Ixazomib (MLN 9708) is an oral proteasome inhibitor” PMID 42376206 ↗ May 2026 “Ixazomib (MLN9708)” NCT02697383 ↗ |
| Known as | NINLARO | “The study seeks to investigate safety and efficacy of ixazomib (NINLARO), a proteasome inhibitor, in multiple sclerosis (MS).” NCT03783416 ↗ |
| Action | Inhibit | “a Second-Generation Proteasome Inhibitor” NCT00830869 ↗ |
| Route | Intravenous | “IXAZOMIB administered intravenously” NCT00830869 ↗ |
| Target | GATA3 | “We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting T-cell-specific transcription factor) expression” NCT02158975 ↗ |