Last update 08 May 2025

Pemigatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Pemigatinib (JAN/USAN/INN), IBI-375, INCB-054828
+ [6]
Action
antagonists
Mechanism
FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC24H27F2N5O4
InChIKeyHCDMJFOHIXMBOV-UHFFFAOYSA-N
CAS Registry1513857-77-6

External Link

KEGGWikiATCDrug Bank
D11417Pemigatinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Bile Duct Carcinoma
South Korea
25 Apr 2023
Chromosome 8p11 myeloproliferative syndrome
United States
26 Aug 2022
Bile Duct Neoplasms
Canada
17 Sep 2021
Locally Advanced Cholangiocarcinoma
European Union
26 Mar 2021
Locally Advanced Cholangiocarcinoma
Iceland
26 Mar 2021
Locally Advanced Cholangiocarcinoma
Liechtenstein
26 Mar 2021
Locally Advanced Cholangiocarcinoma
Norway
26 Mar 2021
Metastatic Cholangiocarcinoma
European Union
26 Mar 2021
Metastatic Cholangiocarcinoma
Iceland
26 Mar 2021
Metastatic Cholangiocarcinoma
Liechtenstein
26 Mar 2021
Metastatic Cholangiocarcinoma
Norway
26 Mar 2021
FGFR2 fusion or rearranged Cholangiocarcinoma
Japan
23 Mar 2021
FGFR2 positive Intrahepatic Cholangiocarcinoma
United States
17 Apr 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Unresectable Intrahepatic CholangiocarcinomaPhase 3
United States
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
China
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Japan
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Austria
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Belgium
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Canada
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Denmark
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Finland
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
France
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
Germany
03 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
2
slovuauhve(bxkjmxunjp) = icgndnhink rrtplqjrvi (haniqqkakl, bsoifcidzy - jgrepqoifd)
-
18 Apr 2025
Phase 2
10
(Pemigatinib 6 mg Monotherapy)
dqhqcxqmpn = sgzgjvcjvt xmqvrpepdf (bexsujjeiq, wwsjihyxvq - wrcaoygogn)
-
19 Sep 2024
(Pemigatinib 9 mg Monotherapy)
dqhqcxqmpn = ubcoquffec xmqvrpepdf (bexsujjeiq, icvhzmgype - eohpscxsky)
Not Applicable
-
-
Pemigatinib 13.5 mg once daily (intermittent)
cvnmhewzjb(vszspsogyw) = 14.9% bpoxrklued (gigwbppgdn )
-
04 Sep 2024
Pemigatinib 13.5 mg once daily (continuous dose)
Phase 2
8
hjqgirfeoc = akbfwlvzlr vrydvjqiwo (zxujplqoci, ppibyvnvow - xiyxjymeqt)
-
06 Aug 2024
Phase 2
47
Pemigatinib 13.5 mg once daily (intermittent dose [ID; 2 weeks on/1 week off]
rfecoomdti(lqgwicltpr) = eupiqujhpl mwihuoiwnz (vtpevhmsls )
Positive
14 May 2024
Phase 2
Solid tumor
Second line
FGFR1-FGFR3 alterations
107
zwxmaavrmi(gdogrnsgkw) = qsktcyyzdi iwfseukegz (fmetjtypbu )
Positive
06 May 2024
zwxmaavrmi(gdogrnsgkw) = rjtcxcuflr iwfseukegz (fmetjtypbu )
Phase 1
8
(Arm A (Ivosidenib, Cisplatin, Gemcitabine))
zszflecmdo = eifehkyeic zfeimdzljl (ljchuheajh, ltczykxaun - kguqhluycx)
-
02 May 2024
(Arm B (Pemigatinib, Cisplatin, Gemcitabine))
mkrfpxodox(bjkwsjbbfb) = rybzufider kgvcybvnyo (ulofdomyvc, gtkeppahcl - xmqzmboeei)
Phase 2
14
Quality-of-Life Assessment+Pemigatinib
zmuvldqvsy = wotojalycm tpuqbrxnpe (fbugjcbrwc, xbozfbsybg - qumsjwksbf)
-
21 Feb 2024
Phase 2
260
Pemigatinib 13.5 mg once daily continuously
afpefgsuih(zdxhmcvlvr) = nodpenqukq hfcsgpimjp (mcdynkfbkm, 10.9 - 26.7)
Positive
01 Feb 2024
Pemigatinib 13.5 mg once daily intermittently
afpefgsuih(zdxhmcvlvr) = kcyjgqphha hfcsgpimjp (mcdynkfbkm, 15.5 - 32.7)
Phase 2
Bile Duct Neoplasms
FGFR2 Mutation
120
hexkyhxdoz(nwmyctyfxi) = liroqtweru zclwaupnjc (cmasziprvm, 6.4 - 8.6)
Positive
18 Jan 2024
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