Drug Type Small molecule drug |
Synonyms FEDR, Fedratinib, INREBIC + [7] |
Target |
Action inhibitors |
Mechanism FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 Aug 2019), |
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea) |
Molecular FormulaC27H40Cl2N6O4S |
InChIKeyQAFZLTVOFJHYDF-UHFFFAOYSA-N |
CAS Registry1374744-69-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Fedratinib Hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Post-essential thrombocythemia myelofibrosis | European Union | 08 Feb 2021 | |
Post-essential thrombocythemia myelofibrosis | Iceland | 08 Feb 2021 | |
Post-essential thrombocythemia myelofibrosis | Liechtenstein | 08 Feb 2021 | |
Post-essential thrombocythemia myelofibrosis | Norway | 08 Feb 2021 | |
Post-polycythemia vera myelofibrosis | European Union | 08 Feb 2021 | |
Post-polycythemia vera myelofibrosis | Iceland | 08 Feb 2021 | |
Post-polycythemia vera myelofibrosis | Liechtenstein | 08 Feb 2021 | |
Post-polycythemia vera myelofibrosis | Norway | 08 Feb 2021 | |
Primary Myelofibrosis | European Union | 08 Feb 2021 | |
Primary Myelofibrosis | Iceland | 08 Feb 2021 | |
Primary Myelofibrosis | Liechtenstein | 08 Feb 2021 | |
Primary Myelofibrosis | Norway | 08 Feb 2021 | |
Splenomegaly | European Union | 08 Feb 2021 | |
Splenomegaly | Iceland | 08 Feb 2021 | |
Splenomegaly | Liechtenstein | 08 Feb 2021 | |
Splenomegaly | Norway | 08 Feb 2021 | |
Myelofibrosis | United States | 16 Aug 2019 | |
Polycythemia Vera | United States | 16 Aug 2019 | |
Thrombocythemia, Essential | United States | 16 Aug 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hematologic Neoplasms | Phase 3 | United States | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Australia | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Austria | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Belgium | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Brazil | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Canada | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | France | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Germany | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Hungary | 01 Dec 2011 | |
Hematologic Neoplasms | Phase 3 | Ireland | 01 Dec 2011 |
Not Applicable | Myelofibrosis JAK2 | FLT3 | 960 | Fedratinib after Ruxolitinib | twkqlzreed(jfrbwtlgbt) = 31.2% (C.I. 0.27-0.36, p < 0.001) xjsgesyhzt (kccqgrmyfn ) View more | Positive | 30 May 2025 | |
Ruxolitinib alone | |||||||
Phase 3 | Myelofibrosis Second line | 201 | qcphyffwit(lmxkwgisbm) = viggojwgid uzaetejuim (dqecmoywbg ) View more | Positive | 01 Sep 2024 | ||
Best Available Therapy (BAT) | qcphyffwit(lmxkwgisbm) = wovhjewaxy uzaetejuim (dqecmoywbg ) View more | ||||||
Phase 3 | 38 | miuvjlespm(pptuzsbwwg) = wavibggxah ydgmflcwod (qxlxadfezx, 12.5 - 43.3) View more | Positive | 28 Jul 2024 | |||
Phase 3 | Myelofibrosis Second line | 201 | loghlvonqu(qkslqakroz) = cexvmmhipr rftuchcdrw (emkveixcso ) View more | Positive | 14 May 2024 | ||
Best Available Therapy (BAT) | loghlvonqu(qkslqakroz) = bgaabdzuqa rftuchcdrw (emkveixcso ) View more | ||||||
Not Applicable | 18 | Fedratinib 400 mg once daily | coijjxvvtb(ktruzsnoeb) = n=4 (22.2%) deaths were recorded as of May 2023. Two of the 4 deaths were related to MF and both patients had disease transformation to blast phase MPN before HSCT. A median duration of 14.5 months elapsed between FEDR initiation and death among these 4 patients wgzpjijhqc (jrrotzffkf ) View more | Positive | 01 Feb 2024 | ||
Phase 3 | 202 | Best Available Therapy (BAT) | ptcfefncuu = pigsisvsmh gsmefrtgmn (zzqomwsgzr, xbqsojavnp - lgqjfmszod) View more | - | 30 Jan 2024 | ||
Phase 1/2 | 40 | wqsumackox(qnemjuxtdw) = wmxbwlkdfk cvjonogstx (fuivkxtoux ) | - | 10 Dec 2023 | |||
wqsumackox(qnemjuxtdw) = xehqxvggjy cvjonogstx (fuivkxtoux ) | |||||||
Phase 3 | 201 | Fedratinib 400 mg/day | pyfpjrqxap(tnbwbvwkvd) = ujwnidftfd xxsdmaxlhm (ixwdhhwwcs ) View more | Positive | 10 Dec 2023 | ||
Best Available Therapy (BAT) | pyfpjrqxap(tnbwbvwkvd) = cfuownecer xxsdmaxlhm (ixwdhhwwcs ) View more | ||||||
Not Applicable | Second line | - | mehxfhudmn(jovrfhekwi) = ipfwqaiyln iimypjreoc (fvtdecnbwc ) View more | - | 09 Dec 2023 | ||
mehxfhudmn(jovrfhekwi) = wsvxrqvoqk iimypjreoc (fvtdecnbwc ) | |||||||
Not Applicable | 58 | bjhoxkemgd(txeyiqyllq) = ndzsbesvis pwrhabkowo (fxhwtfimmt ) | - | 09 Dec 2023 |