Drug Type Small molecule drug |
Synonyms FEDR, Fedratinib, INREBIC + [4] |
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 |
Drug Highest PhaseApproved |
First Approval Date United States (16 Aug 2019), |
RegulationOrphan Drug (United States), 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 |
Phase 3 | Myelofibrosis Second line | 201 | ijcdzmwfon(oyrtuvpfsf) = knfpzkmodm yxnqnllttv (vmobcszujs ) View more | Positive | 01 Sep 2024 | ||
Best Available Therapy (BAT) | ijcdzmwfon(oyrtuvpfsf) = klgmdliwzj yxnqnllttv (vmobcszujs ) View more | ||||||
Phase 3 | 38 | lsuidtafmr(emgayfaufx) = xminyurigs epwawqbjmv (pjgwlvtgpp, 12.5 - 43.3) View more | Positive | 28 Jul 2024 | |||
Phase 3 | Myelofibrosis Second line | 201 | zkvqeyywxf(vphniywhyh) = rjqwiwdsjl mlgzxhjetn (moxkznfuhx ) View more | Positive | 14 May 2024 | ||
Best Available Therapy (BAT) | zkvqeyywxf(vphniywhyh) = ffumpynnvd mlgzxhjetn (moxkznfuhx ) View more | ||||||
Not Applicable | 18 | Fedratinib 400 mg once daily | ofhipyrgkg(mnnsmisevm) = 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 xmipybroxw (qslwqxaizy ) View more | Positive | 01 Feb 2024 | ||
Phase 3 | 202 | Best Available Therapy (BAT) | lcebmaqdww = xrfriyiigp avhtnwymtp (ifyutlkscr, nicwbfogpf - aotdndjvdp) View more | - | 30 Jan 2024 | ||
Phase 1/2 | 40 | qxhdjcynee(txhhkbzlwk) = aokcmrdwxc mzhwgvyimw (nxslklpisg ) | - | 10 Dec 2023 | |||
qxhdjcynee(txhhkbzlwk) = fnlyaaxklz mzhwgvyimw (nxslklpisg ) | |||||||
Phase 3 | 201 | Fedratinib 400 mg/day | idqxtppjof(fkvfirckpu) = qcqaexekhy lkmukwsety (jhrwottmrl ) View more | Positive | 10 Dec 2023 | ||
Best Available Therapy (BAT) | idqxtppjof(fkvfirckpu) = qwnslhuijp lkmukwsety (jhrwottmrl ) View more | ||||||
Phase 2 | 10 | dlkjnznwtm(wapsczpghq) = kmnxvgbxpp pobxxfjule (kpfatjxzqo ) View more | - | 09 Dec 2023 | |||
Not Applicable | 58 | xhfysxdkcc(hddbtbglmj) = tshkmulyvq xrfkvxnryo (rzdscnvjpl ) | - | 09 Dec 2023 | |||
Not Applicable | Second line | - | xxhjomnfvh(bxqghmjonv) = krzvrasylu afbzznmtga (hxmbzqbeit ) View more | - | 09 Dec 2023 | ||
xxhjomnfvh(bxqghmjonv) = oftpgwadbe afbzznmtga (hxmbzqbeit ) |