Drugs / Fedratinib
Fedratinib
also known as
SAR302503 · TG101348 · Fedratinib dihydrochloride monohydrate · FEDRATINIB HYDROCHLORIDE · Fedratinib hydrochloride monohydrate · Inrebic · SAR302503A
Small molecule targets FLT3, JAK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Inrebic | — | 2021-02-08 | europa.eu ↗ |
| Approved | US (FDA) | INREBIC | — | 2019-08-16 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT05127174 | Mar 2022 → Jan 2025 | myeloproliferative neoplasm | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 1 | NCT05524857 | Jan 2022 → Apr 2024 | myeloproliferative neoplasm | Joseph Jurcic | Terminated | No outcome recorded |
| Phase 1 | NCT04955938 | Oct 2021 → Jun 2023 | myeloproliferative neoplasm | University of Chicago | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05051553 | Sep → Dec 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04702464 | Jan → May 2021 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04231435 | Dec 2019 → Feb 2020 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03983161 | Sep 2019 → Jan 2023 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03983239 | Jun → Nov 2019 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01836705 | May → Nov 2013 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01762462 | Dec 2012 → Mar 2013 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01763190 | Nov 2012 → Jul 2013 | impaired renal function disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01585623 | Jun 2012 → Mar 2013 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00631462 | Jan 2008 → Oct 2009 | myelofibrosis | TargeGen | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04817007 | Mar 2021 → Aug 2028 expected | myelofibrosis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04446650 | Oct 2020 → Oct 2023 overdue | primary myelofibrosis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00724334 | Jul 2008 → May 2014 | myelofibrosis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 28 trials · 1 met primary | ||||||
| Phase 2 | NCT05393674 | Jun 2022 → Nov 2025 | myelofibrosis, primary myelofibrosis | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Completed | No outcome recorded |
| Phase 2 | NCT05177211 | Mar 2022 → Apr 2025 | chronic neutrophilic leukemia, myelodysplastic syndrome | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT04370301 | Feb 2021 → Apr 2027 expected | myelofibrosis, primary myelofibrosis | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04282187 | Mar 2020 → Nov 2027 expected | acquired polycythemia vera, acute myeloid leukemia, essential thrombocythemia, myelodysplastic syndrome +4 | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT01692366 | Nov 2012 → Mar 2014 | myelofibrosis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01523171 | Apr 2012 → Apr 2014 | hematopoietic and lymphoid cell neoplasm | Bristol-Myers Squibb | Terminated | Met primary |
| Phase 2 | NCT01420783 | Oct 2011 → Nov 2012 | hematopoietic and lymphoid cell neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01420770 | Aug 2011 → Apr 2014 | hematopoietic and lymphoid cell neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 33 trials · 3 met primary | ||||||
| Phase 3 | NCT03952039 | Sep 2019 → Dec 2022 | acquired polycythemia vera, myelofibrosis, primary myelofibrosis | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT03755518 | Mar 2019 → Nov 2021 | myelofibrosis, primary myelofibrosis | Celgene Corporation | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT01437787 | Dec 2011 → Jun 2014 | hematopoietic and lymphoid cell neoplasm | Bristol-Myers Squibb | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT03723148 | — | myelofibrosis | Celgene Corporation | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2021-02-08 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval for Inrebic® (fedratinib) for Adult Patients with Newly Diagnosed and Previously Treated Myelofibrosis bms.com ↗
The centralized Marketing Authorization approves use of Inrebic in all European Union (EU) member states, as well as Norway, Iceland and Liechtenstein.* |
| 2020-12-11 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Inrebic® (fedratinib) for Adult Patients with Newly Diagnosed and Previously Treated Myelofibrosis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Inrebic ® (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. |
All press releases naming this drug 3 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fedratinib | “Safety and efficacy of fedratinib in patients with myelofibrosis previously treated with ruxolitinib: primary analysis of FREEDOM trial.” PMID 38838026 ↗ Jun 2024 |
| Known as | Fedratinib dihydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1287853 ↗ |
| Known as | FEDRATINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1287853 ↗ |
| Known as | Fedratinib hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1287853 ↗ |
| Known as | Inrebic | “Drug: Fedratinib Oral Capsule [Inrebic]” NCT05393674 ↗ |
| Known as | SAR302503 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01762462 ↗ |
| Known as | SAR302503A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1287853 ↗ |
| Known as | TG101348 | “SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2).” NCT00724334 ↗ |
| Action | Inhibit | “TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2).” NCT00631462 ↗ |
| Modality | Small molecule | “TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2).” NCT00631462 ↗ |
| Route | Oral | “Orally administered, once a day, for 28 days, up to 6 cycles.” NCT00631462 ↗ |
| Target | JAK2 | “TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2).” NCT00631462 ↗ |