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Drug

Futibatinib

Approved · EMA
ClassFibroblast growth factor receptor inhibitorEmerging researchLate-stage development

Also known as Lytgobi.

RxNorm2628190ChEMBLCHEMBL3701238ATCL01EN04UNII4B93MGE4AL
1
Research papers
9
Active clinical trials
4
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Clinical trial2026-07-10Results expected Q1 2031 · ClinicalTrials.gov

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

Clinical trial2026-06-10Results expected Q4 2030 · ClinicalTrials.gov

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Clinical trial2026-05-29Results expected Q4 2027 · ClinicalTrials.gov

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study

Clinical trial2026-05-28Results expected Q2 2027 · ClinicalTrials.gov

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

Clinical trial2026-05-19Results expected Q2 2027 · ClinicalTrials.gov

A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Clinical trial2026-05-18Results expected Q3 2030 · ClinicalTrials.gov

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications

Clinical trial2026-03-17Terminated · ClinicalTrials.gov

A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Clinical trial2026-01-28Primary completion · ClinicalTrials.gov

A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy

Clinical trial2025-12-17Results expected Q4 2026 · ClinicalTrials.gov

Phase II Study of FGFR Inhibitor Futibatinib in Combination With Anti-PD-1 Antibody Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma With FGF19 Expression After First Line Therapy

Clinical trial2025-11-18Results posted · ClinicalTrials.gov

Approval: Lytgobi (EMA)

Regulatory2023-07-04EMA

Futibatinib for <i>FGFR2</i>-Rearranged Intrahepatic Cholangiocarcinoma.

Research2023-01-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Futibatinib
Aliases & brands
Lytgobi
RxNorm CUI
2628190
ChEMBL ID
CHEMBL3701238
ATC codes
L01EN04
UNII
4B93MGE4AL
Primary mechanism
Fibroblast growth factor receptor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Fibroblast growth factor receptor 3
FGFR3 · P22607
INHIBITORFibroblast growth factor receptor inhibitor
Fibroblast growth factor receptor 1
FGFR1 · P11362
INHIBITORFibroblast growth factor receptor inhibitor
Fibroblast growth factor receptor 4
FGFR4 · P22455
INHIBITORFibroblast growth factor receptor inhibitor
Fibroblast growth factor receptor 2
FGFR2 · P21802
INHIBITORFibroblast growth factor receptor inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-07-04
Latest approval
2023-07-04
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-07-04Approval
Approval: Lytgobi (EMA)
Indication: Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2)… Show full indication

Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

17 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
17
registered trials across all phases
LATEST COMPLETION 2025
9
Active studies
8
Recruiting
3
Late-stage (III+)
2
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 17
Phase 12Phase 1 / 22Phase 210Phase 2 / 31Phase 32

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Futibatinib for <i>FGFR2</i>-Rearranged Intrahepatic Cholangiocarcinoma.

The New England journal of medicine · 2023 · 420 cites
Recent papers

Futibatinib for <i>FGFR2</i>-Rearranged Intrahepatic Cholangiocarcinoma.

The New England journal of medicine · 2023 · 420 cites
Major research themes6
Antineoplastic Agents1Bile Duct Neoplasms1Bile Ducts, Intrahepatic1Cholangiocarcinoma1Protein Kinase Inhibitors1Receptor, Fibroblast Growth Factor, Type 21
Journals, researchers & institutions
Top journals
  • The New England journal of medicine1
Leading researchers
  • Abrams TA1
  • Ahn D1
  • Benhadji KA1
  • Bridgewater JA1
  • Cassier PA1
  • Chang HM1
  • Chen LT1
  • Epstein RS1
Leading institutions
free-text, unnormalised
  • Stanford University School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.