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futibatinib

Trade name: Lytgobi

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Sep 30, 2022

Clinical trial activity

16 trials · 26 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
14
Phase 3
4
Phase 4
0

Earliest trial started Jul 1, 2014 (NCT02052778)

Timeline

2010s

  1. Jan 1, 2014

    Otsuka — Earliest Phase 1 Sponsor(trial)

  2. May 23, 2018

    Orphan Drug Designation

  3. Jan 1, 2019

    Otsuka — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Sep 30, 2022

    Otsuka — Earliest FDA Approval

  2. Sep 30, 2022

    Taiho Pharmaceutical — Marketing Organization

  3. Sep 30, 2022

    Otsuka — NDA Secondary Org

  4. Sep 30, 2022

    Otsuka — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughSep 30, 2022

Chemistry & pharmacology

Loading structure…

SMILES

C=CC(=O)N1CC[C@H](n2nc(C#Cc3cc(OC)cc(OC)c3)c3c(N)ncnc32)C1
Mol. weight
418.46 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • tas-120
  • tas-120

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06722183Phase 2Mar 31, 2025IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, Institut für Klinische Krebsforschung IKF GmbH
NCT06263153Phase 2Nov 1, 2024Gateway for Cancer Research, Ohio State University
NCT06506955Phase 2/Phase 3 (Phase 3)Oct 1, 2024Otsuka
NCT05615818Phase 3Jul 18, 2024Accord Research, Belgian Group of Digestive Oncology, Cancer Research UK, Center Eugene Marquis, Institut Mutualiste Montsouris, National Cancer Institute, France, Otsuka, Pierre Fabre, Servier, UNICANCER, Université catholique de Louvain, University of London, Zymeworks Inc.
NCT05945823Phase 2Jul 13, 2023Otsuka
NCT05727176Phase 2May 12, 2023Otsuka
NCT05036681Phase 2Oct 1, 2021National Comprehensive Cancer Network, University of Texas at Houston
NCT04965818Phase 1/Phase 2 (Phase 2)Sep 20, 2021Otsuka
NCT04828486Phase 2May 7, 2021Mayo Clinic, National Cancer Institute (NCI)
NCT04601857Phase 2Nov 30, 2020Merck, Otsuka
NCT04189445Phase 2Jun 30, 2020Otsuka
NCT04093362Phase 3Mar 1, 2020Otsuka
NCT04024436Phase 2Aug 30, 2019Otsuka
NCT03784014Phase 3Mar 31, 2019Commissariat A L'energie Atomique, Hôpital Européen Georges-Pompidou, Institut Bergonié, Institut National de la Santé Et de la Recherche Médicale, France
NCT02052778Phase 1/Phase 2 (Phase 2)Jul 1, 2014Otsuka
NCT04507503N/A—Otsuka
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
OtsukaFor profit111032014
Accord ResearchFor profit1012024
Belgian Group of Digestive OncologyAcademic/Hospital1012024
Cancer Research UKAcademic/Hospital1012024
Center Eugene MarquisAcademic/Hospital1012024
Commissariat A L'energie AtomiqueGovernment1012019
Gateway for Cancer ResearchAcademic/Hospital1012024
Hôpital Européen Georges-PompidouAcademic/Hospital1012019
IKF Klinische Krebsforschung GmbH am Krankenhaus NordwestAcademic/Hospital1112025
Institut BergoniéAcademic/Hospital1012019
Institut für Klinische Krebsforschung IKF GmbHAcademic/Hospital1012025
Institut Mutualiste MontsourisAcademic/Hospital1012024
Institut National de la Santé Et de la Recherche Médicale, FranceAcademic/Hospital1112019
Mayo ClinicAcademic/Hospital1112021
MerckFor profit1012020
National Cancer Institute, FranceGovernment1012024
National Cancer Institute (NCI)Government1012021
National Comprehensive Cancer NetworkAcademic/Hospital1012021
Ohio State UniversityAcademic/Hospital1112024
Pierre FabreFor profit1012024
26 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
OtsukaFor profitNDA2Sep 30, 2022
OtsukaFor profitNDASep 30, 2022
Taiho PharmaceuticalFor profitMKTGSep 30, 2022