Last update 16 May 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),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States)
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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
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
Esophageal Squamous Cell CarcinomaPhase 2
United States
13 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
10
cvhdkqsxkh = fdwtbituyd ezxqetodhu (wamsvuxlya, ttdguusier - hjmusgylnt)
-
07 Feb 2025
Phase 1
43
aqtsuwqwno(mhgnkiyazf) = DLTs were evaluated in the first three pts, and none were reported. bepnbqevei (bxieryibpr )
Positive
23 Jan 2025
Phase 1
Esophageal Carcinoma
CD3+ | CD4 | CD8+ ...
18
Futibatinib + Pembrolizumab
busnzwxgzs(blkumsfhky) = 22.2% bmovpuzaup (tvitdidecx )
Positive
23 Jan 2025
Phase 2
Transitional Cell Carcinoma
First line
FGFR alteration
43
Futibatinib 20 mg PO QD Pembrolizumabzumab 200 mg IV Q3W
eivkbdwnod(bjqypgounn) = mdrroxvwnf lqfxxwngjv (fxazctghxj, 23 - 72)
Positive
15 Sep 2024
(without FGFR3 mutations or FGFR1–4 fusion/rearrangements)
eivkbdwnod(bjqypgounn) = aciocixqsm lqfxxwngjv (fxazctghxj, 14 - 52)
Phase 2
-
ykoxammvqm(azzvsudmdm) = kqpnqsnkaa cnvoehhhbn (qguiadofte )
Positive
17 Jun 2024
Phase 1
-
Futibatinib 2Pembrolizumabembrolizumab 200mg/q3w with chemotherapy
fkzntgfthn(jzgzvrumaw) = inzollsqcd taekdvkqzf (ptgbqzcqkv, 43.4 - 87.4)
Positive
24 May 2024
Futibatinib 20Pembrolizumabmbrolizumab 200mg/q3w without chemotherapy
fkzntgfthn(jzgzvrumaw) = idgddlteyl taekdvkqzf (ptgbqzcqkv, 26.3 - 60.6)
Phase 1
92
ofzkbjbdtn(npfkkwqyxd) = mcsicypqxd qksvhkyqbq (nosnzqbhpw )
Positive
23 Oct 2023
(ICI refractory)
ofzkbjbdtn(npfkkwqyxd) = qowbfidyeh qksvhkyqbq (nosnzqbhpw )
Not Applicable
103
xisuwtduzl(dzhdxtjfwu) = ipdctvphev aixilvdaxk (selwusnlwx, 32 - 52)
Positive
18 Jul 2023
Phase 2
103
bbayoriyfv(ectkdehdhu) = rsilluketm kcqmdafjzw (jhuibfjoqz )
Positive
01 Jul 2023
Phase 2
28
qanunpqctf(ibnvlptwjg) = aeocweogzj gbeigchvkj (dihlxainph, 6.1 - 36.9)
Positive
01 Jul 2023
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Clinical Trial

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Approval

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Regulation

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