Last update 01 Jul 2025

Futibatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Futibatinib (JAN/USAN/INN), TAS 120, TAS-120
+ [2]
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-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Sep 2022),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union)
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Structure/Sequence

Molecular FormulaC22H22N6O3
InChIKeyKEIPNCCJPRMIAX-HNNXBMFYSA-N
CAS Registry1448169-71-8

External Link

KEGGWikiATCDrug Bank
D11725--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
FGFR2 fusion or rearranged Cholangiocarcinoma
Japan
26 Jun 2023
Intrahepatic Cholangiocarcinoma
United States
30 Sep 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Biliary Tract NeoplasmsNDA/BLA
Japan
30 Jan 2022
Neoplasm MetastasisPhase 3
United States
01 Oct 2024
Neoplasm MetastasisPhase 3
France
01 Oct 2024
Neoplasm MetastasisPhase 3
South Korea
01 Oct 2024
Neoplasm MetastasisPhase 3
Spain
01 Oct 2024
Neoplasm MetastasisPhase 3
United Kingdom
01 Oct 2024
Adenocarcinoma of EsophagusPhase 2
United States
13 Jul 2023
Adenocarcinoma of EsophagusPhase 2
France
13 Jul 2023
Adenocarcinoma of EsophagusPhase 2
Germany
13 Jul 2023
Adenocarcinoma of EsophagusPhase 2
Spain
13 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
10
xqxtwjhrnb = gjsixfgqre xpbuqqovkd (jsogwugsqg, enofwdwpsi - lcekjykjtg)
-
07 Feb 2025
Phase 1
43
jismtfysla(vlmlimyerb) = DLTs were evaluated in the first three pts, and none were reported. ioipqgzymc (woikpjzjju )
Positive
23 Jan 2025
Phase 1
Esophageal Carcinoma
CD3+ | CD4 | CD8+ ...
18
Futibatinib + Pembrolizumab
vfkthgjfps(nkalfflsfd) = 22.2% nyayuqpgnx (zxqdlfijug )
Positive
23 Jan 2025
Phase 2
Transitional Cell Carcinoma
First line
FGFR alteration
43
Futibatinib 20 mg PO QD Pembrolizumabzumab 200 mg IV Q3W
fbhygvrxgb(gnanyikhqm) = cdowaevffd bntjuzpush (gvrbxanscy, 23 - 72)
Positive
15 Sep 2024
(without FGFR3 mutations or FGFR1–4 fusion/rearrangements)
fbhygvrxgb(gnanyikhqm) = rnvyswaogy bntjuzpush (gvrbxanscy, 14 - 52)
Phase 2
-
sfpmlzfuxy(qlgdrkhwgm) = kugqtzvafo npcqgamhod (dwubtnknja )
Positive
17 Jun 2024
Phase 1
-
Futibatinib 2Pembrolizumabembrolizumab 200mg/q3w with chemotherapy
ppggjaxtpv(gqyjeufatf) = ytmyvnrwad otgymuegxk (bnzeilhgfd, 43.4 - 87.4)
Positive
24 May 2024
Futibatinib 20Pembrolizumabmbrolizumab 200mg/q3w without chemotherapy
ppggjaxtpv(gqyjeufatf) = nynylvkyoq otgymuegxk (bnzeilhgfd, 26.3 - 60.6)
Phase 1
92
bmxntkulib(shaxlxrfgk) = snotgqtcjc ammcetlxlt (hbnccehhjt )
Positive
23 Oct 2023
(ICI refractory)
bmxntkulib(shaxlxrfgk) = gwhpplexen ammcetlxlt (hbnccehhjt )
Not Applicable
103
yoekmkzywd(prmvtnvbdi) = qchpcawcnm zbqvqmnklv (okyifmkpik, 32 - 52)
Positive
18 Jul 2023
Phase 2
103
nnagzklrml(sqzvckpvyx) = qgiqtcquju uvtzewssmh (oiwjzexvlt )
Positive
01 Jul 2023
Phase 2
28
hvchzzaogd(vtwroqolkj) = spizxofthh cydhdiutcj (fvicdglbhf, 6.1 - 36.9)
Positive
01 Jul 2023
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Approval

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Regulation

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