Last update 06 Apr 2025

Fedratinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
FEDR, Fedratinib, INREBIC
+ [4]
Action
inhibitors
Mechanism
FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC27H40Cl2N6O4S
InChIKeyQAFZLTVOFJHYDF-UHFFFAOYSA-N
CAS Registry1374744-69-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hematologic NeoplasmsPhase 3
United States
01 Dec 2011
Hematologic NeoplasmsPhase 3
Australia
01 Dec 2011
Hematologic NeoplasmsPhase 3
Austria
01 Dec 2011
Hematologic NeoplasmsPhase 3
Belgium
01 Dec 2011
Hematologic NeoplasmsPhase 3
Brazil
01 Dec 2011
Hematologic NeoplasmsPhase 3
Canada
01 Dec 2011
Hematologic NeoplasmsPhase 3
France
01 Dec 2011
Hematologic NeoplasmsPhase 3
Germany
01 Dec 2011
Hematologic NeoplasmsPhase 3
Hungary
01 Dec 2011
Hematologic NeoplasmsPhase 3
Ireland
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Myelofibrosis
Second line
201
ijcdzmwfon(oyrtuvpfsf) = knfpzkmodm yxnqnllttv (vmobcszujs )
Positive
01 Sep 2024
Best Available Therapy (BAT)
ijcdzmwfon(oyrtuvpfsf) = klgmdliwzj yxnqnllttv (vmobcszujs )
Phase 3
38
lsuidtafmr(emgayfaufx) = xminyurigs epwawqbjmv (pjgwlvtgpp, 12.5 - 43.3)
Positive
28 Jul 2024
Phase 3
Myelofibrosis
Second line
201
zkvqeyywxf(vphniywhyh) = rjqwiwdsjl mlgzxhjetn (moxkznfuhx )
Positive
14 May 2024
Best Available Therapy (BAT)
zkvqeyywxf(vphniywhyh) = ffumpynnvd mlgzxhjetn (moxkznfuhx )
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 )
Positive
01 Feb 2024
Phase 3
202
Best Available Therapy (BAT)
lcebmaqdww = xrfriyiigp avhtnwymtp (ifyutlkscr, nicwbfogpf - aotdndjvdp)
-
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 )
Positive
10 Dec 2023
Best Available Therapy (BAT)
idqxtppjof(fkvfirckpu) = qwnslhuijp lkmukwsety (jhrwottmrl )
Phase 2
10
dlkjnznwtm(wapsczpghq) = kmnxvgbxpp pobxxfjule (kpfatjxzqo )
-
09 Dec 2023
Not Applicable
58
xhfysxdkcc(hddbtbglmj) = tshkmulyvq xrfkvxnryo (rzdscnvjpl )
-
09 Dec 2023
Not Applicable
Second line
-
xxhjomnfvh(bxqghmjonv) = krzvrasylu afbzznmtga (hxmbzqbeit )
-
09 Dec 2023
xxhjomnfvh(bxqghmjonv) = oftpgwadbe afbzznmtga (hxmbzqbeit )
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