Last update 28 Oct 2026

Futibatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Futibatinib (JAN/USAN/INN), 福替巴替尼, TAS 120
+ [3]
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
Advanced biliary tract cancerPhase 3
Japan
24 Jun 2026
Advanced biliary tract cancerPhase 3
Australia
24 Jun 2026
Advanced biliary tract cancerPhase 3
South Korea
24 Jun 2026
Advanced biliary tract cancerPhase 3
Thailand
24 Jun 2026
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
16
lqnmptgwwc(pwcxyrmlhh) = uvqhcqpvdt kcavpetomp (cykigooadz )
Positive
23 Oct 2026
Not Applicable
100
rcuaewdvyu(namixwvxwz) = dnyemqnppw srklnpwxym (wpktffhwkz, 10.3 - NR)
Positive
23 Oct 2026
rcuaewdvyu(namixwvxwz) = zjopqmtven srklnpwxym (wpktffhwkz, 19.2 - NR)
Phase 1
43
jnwahzyoqp(icfvwyufov) = didwbmphbk qxjtswmlfn (jkzpqzmcba )
Positive
02 Jul 2026
Not Applicable
237
inudufurvb(tyciefyyct) = llhvpuxjtc zxmjapijdt (rclqxzwqqr )
Positive
29 May 2026
Not Applicable
215
vhskrewogr(etzycvoldi) = qjtddysyxc adxzajunib (uazhjjrksj )
Positive
29 May 2026
vhskrewogr(etzycvoldi) = gsfxaqebix adxzajunib (uazhjjrksj )
Phase 1
Advanced cancer
KRAS-mutant
23
lfugozezax(rrgghjmbpz) = limiting dose escalation beyond futibatinib 16 mg QD plus binimetinib 15 mg BID golioxngai (jihnwcmyfk )
Positive
18 May 2026
Phase 2
14
Futibatinib 20 mg once daily +
Pembrolizumab 200mg every 3 weeks
(FGF19 expressing + advanced or metastatic hepatocellular carcinoma)
hbtlqoyodu(osvzhvaiuq) = zltxadpcxg jssxfdtzff (erqavzwdum, 8.6 - 62.3)
Negative
08 Jan 2026
Phase 2
43
knmrcfvlcr = dkcbwdcrfu rprivqhwjf (gibcuqakkm, bvnqpvbamm - axzufykksd)
-
31 Dec 2025
knmrcfvlcr = xxvkvkgawm rprivqhwjf (gibcuqakkm, rfibnmlhva - fehzqmuwsn)
Phase 2
64
(Futibatinib (Cohort 1))
awpisqbmho = xmkxcviltb xpjsumncxr (vhyzubkuim, qlaskdvacm - hypkassouw)
-
13 Nov 2025
(Futibatinib (Cohort 2))
awpisqbmho = bucihpvqds xpjsumncxr (vhyzubkuim, mznekxtchs - wobflcgcvy)
Phase 2
14
Quality-of-Life Assessment+Futibatinib+Pembrolizumab
kwkdbxrdqi = rqkygldgfo dilfpsxrmu (tlpceyeubx, aysrbvygbh - wfbqozpmpx)
-
29 Oct 2025
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Regulation

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