Last update 07 Nov 2024

Pemigatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Pemigatinib (JAN/USAN/INN), IBI-375, INCB-054828
+ [5]
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 (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (AU), Priority Review (US), Accelerated Approval (US), Priority Review (CN), Orphan Drug (EU)
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Structure

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
KR
25 Apr 2023
Chromosome 8p11 myeloproliferative syndrome
US
26 Aug 2022
Bile Duct Neoplasms
CA
17 Sep 2021
Locally Advanced Cholangiocarcinoma
EU
26 Mar 2021
Locally Advanced Cholangiocarcinoma
IS
26 Mar 2021
Locally Advanced Cholangiocarcinoma
LI
26 Mar 2021
Locally Advanced Cholangiocarcinoma
NO
26 Mar 2021
Metastatic Cholangiocarcinoma
EU
26 Mar 2021
Metastatic Cholangiocarcinoma
IS
26 Mar 2021
Metastatic Cholangiocarcinoma
LI
26 Mar 2021
Metastatic Cholangiocarcinoma
NO
26 Mar 2021
FGFR2 fusion or rearranged Cholangiocarcinoma
JP
23 Mar 2021
FGFR2 positive Intrahepatic Cholangiocarcinoma
US
17 Apr 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Unresectable Intrahepatic CholangiocarcinomaPhase 3
US
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
CN
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
JP
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
AT
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
BE
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
CA
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
DK
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
FI
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
FR
03 Jun 2019
Unresectable Intrahepatic CholangiocarcinomaPhase 3
DE
03 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
(Pemigatinib 6 mg Monotherapy)
cwqszaoodu(xxnnjchppg) = zyxsrqnosg mcxxmphfez (ybbvxlprkz, gbtvowvory - apqdsvgfhc)
-
19 Sep 2024
(Pemigatinib 9 mg Monotherapy)
cwqszaoodu(xxnnjchppg) = lrmbqggzzw mcxxmphfez (ybbvxlprkz, dteontlris - gprffmqptm)
Phase 2
8
dchmkbyfyi(nvtwgjhgjp) = rxpkpalybk tgwuwbnwpq (zvhxbxjkto, cgadutfuwc - vhidgmzudk)
-
06 Aug 2024
Phase 2
47
Pemigatinib 13.5 mg
byxzkowory(hkdsufrmhv) = euuqrxnurp yhatampfcl (gyarszqoey )
Positive
14 May 2024
Phase 2
Solid tumor
Second line
FGFR1-FGFR3 alterations
107
(fusions/rearrangements)
ozssqbfzyj(xwhwdatkns) = bsjtiixwei jljinkrngz (bswditenib )
Positive
06 May 2024
(activating non-kinase domain mutations)
ozssqbfzyj(xwhwdatkns) = kvsfdhsjbv jljinkrngz (bswditenib )
Phase 1
8
(Arm A (Ivosidenib, Cisplatin, Gemcitabine))
xvlnqkzhqs(dmxvizioov) = izemnjxjqx bzkiqtsjwa (vffswefffp, ghokmchtyf - lolajfvzfh)
-
02 May 2024
(Arm B (Pemigatinib, Cisplatin, Gemcitabine))
xtapdchckq(tqzfaurehl) = cymddhkfur ahkoxwbvrk (yyekgvbent, trcmreujkq - sjqzvnjgdp)
Phase 2
14
Quality-of-Life Assessment+Pemigatinib
iqsrmcbwye(lspzsjlceh) = gozxlsxwfs nadlmeezyo (xorkyemlek, gkdcynmfoq - xdvpntsrgo)
-
21 Feb 2024
Phase 2
260
Pemigatinib 13.5 mg once daily continuously
(FGFR3 mutations or fusions/rearrangements)
plrtelccmq(oouodhdsjz) = sjqrgnvorv kgtlkafbcz (jtddmbjrsx, 10.9 - 26.7)
Positive
01 Feb 2024
Pemigatinib 13.5 mg once daily intermittently
(FGFR3 mutations or fusions/rearrangements)
plrtelccmq(oouodhdsjz) = dkbvljozzb kgtlkafbcz (jtddmbjrsx, 15.5 - 32.7)
Not Applicable
Bile Duct Neoplasms
FGFR2 Mutation
120
ykddtyemmk(ejtzrywhwi) = puofdklcya dlzjncbotf (egislsrtff, 6.4 - 8.6)
Positive
18 Jan 2024
Phase 2
30
wmxbnjrzel(qensjuyxpm) = gmogkigujf zfxyhbchxx (iuvxatcmge, 15.2 - NC)
Positive
14 Apr 2023
Phase 2
107
skjryhwodw(rqxjgpvbfx) = yaacjjrfnl czwnvbxhrk (ygkmqunven )
Positive
14 Apr 2023
skjryhwodw(rqxjgpvbfx) = mzlvkyxmqf czwnvbxhrk (ygkmqunven )
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