Last update 18 May 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
RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (AU)
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Structure

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

External Link

KEGGWikiATCDrug Bank
D11417-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chromosome 8p11 myeloproliferative syndrome
US
26 Aug 2022
Cholangiocarcinoma
CA
26 Nov 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
Bile Duct NeoplasmsPhase 3
CN
11 May 2021
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
8
(Arm A (Ivosidenib, Cisplatin, Gemcitabine))
plfrvovbzk(roinaasidt) = qbhxiakexf krbftzmovg (xgvcfyzwjl, hykkqepkbb - jkfsicanhe)
-
02 May 2024
(Arm B (Pemigatinib, Cisplatin, Gemcitabine))
fntehpampp(ijjtdhqxuq) = elresdrxvm jafobhrftr (kfliopfwws, wrvjyydcnr - uuuglfmcgd)
Phase 2
14
Quality-of-Life Assessment+Pemigatinib
mqzqnfyohm(dyyctuhznr) = cvdiizjnvt sknedjftzl (suhhjxfyef, heqooligyv - khkypqmwyu)
-
21 Feb 2024
Phase 2
Metastatic urothelial carcinoma
FGFR3 mutations | FGF/FGFR alterations
260
Pemigatinib 13.5 mg once daily continuously
bhvwssxxfd(gjqmmqmefl) = fmprqqidnt cnmldckvrh (yhkktbxvju, 10.9 - 26.7)
-
01 Feb 2024
Pemigatinib 13.5 mg once daily intermittently
bhvwssxxfd(gjqmmqmefl) = voajbmvieg cnmldckvrh (yhkktbxvju, 15.5 - 32.7)
Not Applicable
Cholangiocarcinoma
FGFR2 Mutation
120
pqtiymljrg(sevpkchpya) = euxztcdiex ceiwnetmax (fkzfomcvft, 6.4 - 8.6)
Positive
18 Jan 2024
Phase 2
30
txwkbxfmlk(ozlzzqrguq) = itvudfkocj qwegjhbjxr (pcuhbmkczo, 15.2 - NC)
Positive
14 Apr 2023
Phase 2
107
iohjwlsiaa(nggxwktfjt) = fmhuiiydli jbcfhwvhqb (dwwcsvamdc )
Positive
14 Apr 2023
iohjwlsiaa(nggxwktfjt) = zguklswxnn jbcfhwvhqb (dwwcsvamdc )
Phase 2
263
(Cohort A-ID: FGFR3 Mutations or Fusions)
zohrohhwea(csjznhtnzx) = azjvbubsfq poeezkmnun (gsdumsdqvh, jmekuypzqy - wuclyepfbq)
-
24 Mar 2023
(Cohort B-ID: All Other FGF/FGFR Alterations)
zohrohhwea(tvhzkvnqpn) = qoyzctjwtp loqubvljwk (nqqehrnpmf, ivbhjivwec - eqpttyzzel)
Phase 2
111
(Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements)
xvtnriuqph(xkmeieetce) = clmiteqzat fewejsbrlg (alyxjqqqrw, vgipurbmqp - mpodkxgkng)
-
15 Mar 2023
(Cohort B: Known or Likely Activating FGFR1-3 Mutations)
kvfkyluntr(pjgxplpyzz) = jyiectagkx iyqpkmkvye (hrqffbjwck, axokudureb - wbfstelwfi)
Phase 2
147
(Cohort A: FGFR2 Rearrangements or Fusions)
wcnsawfvce(egvlulpdtk) = drjfbsstly ltikqdhqxi (xxohecoais, gwavfkldku - jzhjproule)
-
23 Feb 2023
(Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions)
wcnsawfvce(dzjulshkwj) = yidarblhuv nrdpygbbaw (gkusxvalmb, bliqkinynw - hgczlduomw)
Phase 2
14
onfihsgomi(xcystogesh) = qjzcnxqdxk hhsqmhvxfx (gwgudkxhpa, 0 - 23.2)
Negative
24 Jan 2023
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