Drugs / Ixazomib
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 2 milestones | |||||
| Filed | EU (EMA) | — | plasma cell myeloma | 2015-08-21 | “the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ixazomib” takeda.com ↗ |
| Filed | US (FDA) | NINLARO | plasma cell myeloma | 2015-07-15 | “a New Drug Application (NDA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for ixazomib” takeda.com ↗ “a New Drug Application for ixazomib was filed with the U.S. Food and Drug Administration (FDA)” takeda.com ↗ “Takeda submitted a New Drug Application for NINLARO to the FDA in July 2015” takeda.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | Japan (PMDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2016-07-04 | “today announced that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for ixazomib” takeda.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
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EU approved 2016
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| 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| Ewing sarcoma, alveolar soft part sarcoma, liposarcoma, malignant peripheral nerve sheath tumor | Matthew Ingham | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03888534 | Oct 2020 → Aug 2022 | precursor lymphoblastic lymphoma/leukemia | Millennium Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03783416 | Jun 2020 → Jul 2027 expected | 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 Stop: Business |
| 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 · 2 met primary · 1 missed | ||||||
| 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 Stop: Business |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 | Met primary |
| 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 Stop: Business |
| Phase 1/2 | NCT02993094 | Nov 2016 → Aug 2020 | triple-negative breast carcinoma | Study Group of Medical Tumour Therapy (AGMT) | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| 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 | Met primary |
| 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 · 3 missed | ||||||
| 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 Stop: Enrollment |
| 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 Stop: Business |
| 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 Stop: Enrollment |
| Phase 2 | NCT04028115 | Oct 2019 → Apr 2024 | plasma cell myeloma | Thomas Lund | Completed | No outcome recorded |
| Phase 2 | NCT04052880 | Oct 2019 → May 2025 | plasma cell myeloma | Larysa Sanchez | Completed | No outcome recorded |
| Phase 2 | NCT03608501 | Sep 2019 → Jun 2021 | plasma cell myeloma | Takeda | Withdrawn | No outcome recorded Stop: Business |
| 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 Stop: Enrollment |
| 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 Stop: Business |
| 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 | Missed primary |
| 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 | NCT02461888 | Dec 2015 → Apr 2022 | plasma cell myeloma | University of Leeds | Completed | No outcome recorded |
| Phase 2 | NCT02578121 | Dec 2015 → Jan 2017 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 | NCT02412228 | Aug 2015 → Mar 2019 | plasma cell myeloma | John L. Reagan | Completed | No outcome recorded |
| Phase 2 | NCT02440464 | Aug 2015 → Oct 2020 | plasma cell myeloma | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 2 | NCT02410694 | Apr 2015 → Mar 2019 | plasma cell myeloma | Study Group of Medical Tumour Therapy (AGMT) | Completed | No outcome recorded |
| Phase 2 | NCT02400437 | Apr 2015 → Nov 2019 | Waldenstrom macroglobulinemia | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02302846 | Mar 2015 → May 2017 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| 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 · 4 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 Stop: Enrollment |
| Phase 3 | NCT02312258 | Apr 2015 → Aug 2019 | plasma cell myeloma | Takeda | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01659658 | Dec 2012 → Jul 2022 | AL amyloidosis | Millennium Pharmaceuticals, Inc. | Terminated | Missed primary |
| Phase 3 | NCT01564537 | Aug 2012 → Oct 2014 | plasma cell myeloma | Takeda | Completed | Met primary |
| 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 Stop: Enrollment |
| 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 |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT04405167 Background | Jul 2020 → May 2025 | plasma cell myeloma | University of Pennsylvania | Terminated | No outcome recorded Stop: Enrollment |
| 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 1/2 | 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 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 3 | NCT05675319 Comparator | Mar 2023 → Mar 2025 | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded Stop: Enrollment |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2020-11-05 | Takeda | Results Takeda Oncology Demonstrates Leadership in Hematologic Cancers at 62nd American Society of Hematology (ASH) Annual Meeting takeda.com ↗
While the trial did not meet the threshold for statistical significance and the primary endpoint of progression-free survival (PFS) was not met, the study found the addition of NINLARO resulted in a 13.5 month increase in median PFS overall. |
| 2020-09-09 | Takeda | Results Takeda Announces Results from Phase 3 Clinical Trial Evaluating NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma takeda.com ↗ |
| 2020-06-12 | Takeda | Results Takeda Presents Positive Data from Clinical Trial Evaluating Oral NINLARO™ (ixazomib) in Multiple Myeloma as a First-Line Maintenance Therapy takeda.com ↗
The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo |
| 2020-03-10 | Takeda | Results Takeda Provides Update on TOURMALINE-MM2 Phase 3 Trial takeda.com ↗
The addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival (PFS) of 13.5 months (35.3 months versus 21.8 months; hazard ratio [HR] 0.83; p=0.073); however, it did not meet the threshold for statistical significance. |
| 2019-12-07 | Takeda | Results Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis takeda.com ↗
Hematologic responses were seen in 53% versus 51% of patients receiving NINLARO plus dexamethasone versus physician’s choice (odds ratio 1.10 [95% CI 0.60-2.01], p=0.762) as assessed by an Adjudication Committee (AC). |
| 2019-11-07 | Takeda | Results 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 ↗
Cambridge, Mass. and Osaka, Japan – Takeda Pharmaceutical Company Limited ( TSE: 4502/NYSE: TAK ) ("Takeda") today announced the randomized, Phase 3 TOURMALINE-MM4 study met its primary endpoint of progression free survival (PFS). |
| 2018-12-02 | Takeda | Results Takeda to Present Positive Data from TOURMALINE-MM3, First Pivotal Phase 3 Placebo Controlled Trial Evaluating Proteasome Inhibitor Treatment in Maintenance Setting takeda.com ↗
This corresponds to a 28 percent reduction in risk of progression or death and a 39 percent improvement in PFS with NINLARO compared with placebo. |
| 2018-07-11 | Takeda | Results 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 ↗
today announced that the randomized, Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral NINLARO ® (ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. |
| 2017-06-23 | Takeda | Results Takeda Presents Data from Phase 1/2 Studies for NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma Patients and in the Maintenance Setting takeda.com ↗
Early studies of weekly and twice-weekly ixazomib plus lenalidomide and dexamethasone demonstrate deep responses after induction, with deepening responses seen after single-agent ixazomib maintenance |
| 2017-05-24 | Takeda | Regulatory NINLARO ® Capsules Now Available for the Treatment of Multiple Myeloma in Japan takeda.com ↗
NINLARO is the first oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone, for which Takeda has obtained the New Drug Application Approval for the treatment of patients with relapsed or refractory multiple myeloma. |
| 2017-03-30 | Takeda | Regulatory Takeda Obtains New Drug Application Approval for NINLARO ® Capsules for the Treatment of Multiple Myeloma in Japan takeda.com ↗
the Japanese Ministry of Health, Labour and Welfare has approved NINLARO ® capsules (generic name: ixazomib, development code: MLN9708, hereinafter: "NINLARO"), |
| 2016-11-24 | Takeda | Regulatory NINLARO TM （ixazomib） Receives Conditional Approval from the European Commission to Treat Multiple Myeloma takeda.com ↗
The decision to approve NINLARO as the first and only oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency （EMA） Committee for Medicinal Products （CHMP） for Human Use in September 2016. |
| 2016-09-16 | Takeda | Regulatory 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 | Regulatory Takeda Receives Marketing Authorization in Canada for NINLARO™ (ixazomib) in Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2016-07-04 | Takeda | Regulatory Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan takeda.com ↗
The NDA was filed based on the results of TOURMALINE-MM1, a global Phase 3 trial published in the New England Journal of Medicine in April. |
| 2016-05-27 | Takeda | Regulatory Takeda Provides Update on EU Marketing Authorization Application for NINLARO® (ixazomib) in Relapsed/Refractory Multiple Myeloma takeda.com ↗
Takeda intends to appeal this opinion and request a re-examination by the CHMP. |
| 2016-04-28 | Takeda | Results Phase 3 Trial Results for First Oral Proteasome Inhibitor NINLARO (ixazomib) Published in The New England Journal of Medicine takeda.com ↗
The TOURMALINE-MM1 results demonstrated that ixazomib in combination with lenalidomide and dexamethasone is an effective and tolerable oral regimen with a manageable safety profile for patients with relapsed and/or refractory multiple myeloma. |
| 2016-02-26 | Takeda | Regulatory Japanese MHLW Grants Orphan Drug Designation in Japan to Takeda's Oral Proteasome Inhibitor Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-12-07 | Takeda | Results 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 ↗
showing that treatment with NINLARO® (ixazomib) capsules is effective in extending progression free survival (PFS) with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma. |
| 2015-11-21 | Takeda | Regulatory U.S. FDA Approves Takeda's NINLARO® (ixazomib), the First and Only Oral Proteasome Inhibitor to Treat Multiple Myeloma takeda.com ↗
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the U.S. Food and Drug Administration (FDA) has approved NINLARO ® (ixazomib) capsules |
| 2015-09-09 | Takeda | Regulatory U.S. FDA Grants Priority Review to Takeda's Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-08-21 | Takeda | Regulatory Takeda Announces European Medicines Agency Acceptance of Ixazomib's Marketing Authorization Application for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. |
| 2015-07-27 | Takeda | Regulatory European Medicines Agency Grants Accelerated Assessment of Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-07-15 | Takeda | Regulatory Takeda Submits New Drug Application for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma takeda.com ↗ |
| 2015-02-10 | Takeda | Results 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 ↗
In the trial, patients treated with investigational ixazomib plus lenalidomide and dexamethasone lived without their disease worsening for a significantly longer time compared to patients who received placebo plus lenalidomide/dexamethasone. |
| 2014-12-08 | Takeda | Results Takeda Presents Phase 2 Data on Maintenance with Single-Agent Investigational Ixazomib in Patients with Newly Diagnosed Multiple Myeloma takeda.com ↗
The data from this trial demonstrate the potential feasibility of single-agent ixazomib maintenance therapy following 12 cycles of ixazomib-lenalidomide-dexamethasone, with deepening responses and an acceptable tolerability profile. |
| 2014-12-02 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy status to the company’s investigational, oral proteasome inhibitor, ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. |
All press releases naming this drug 32 releases
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 (ixazomib citrate)” NCT02481310 ↗ “ixazomib citrate (ixazomib)” NCT01864018 ↗ “MLN9708 (ixazomib citrate)” NCT04847453 ↗ “Drug: Ixazomib Citrate” NCT01718743 ↗ |
| 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 ↗ |