Wednesday, July 8, 2026

Drug profile · INN

futibatinib

futibatinib (LYTGOBI) is a fibroblast growth factor receptor inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01EN04
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — futibatinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
8
Data quality
0.84

Quick answer

futibatinib (LYTGOBI) is a fibroblast growth factor receptor inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN futibatinib
Brand LYTGOBI
Mechanism Fibroblast growth factor receptor inhibitor
Target Fibroblast growth factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EN04

Mechanism of action

Fibroblast growth factor receptor inhibitor

Primary target: Fibroblast growth factor receptor

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Pipeline programs

  1. C16-40 Phase 3 · George Institute for · Unresectable locally advanced and/or metastatic soft-tissue
  2. Futibatinib, FULVESTRANT Phase 3 · Taiho Pharma Canada · Malignant Solid Tumors
  3. IMFINZI for Advanced Biliary Cancer (ABC) Phase 3 · Ningbo Cancer Hospital · Advanced Biliary Cancer (ABC)
  4. 2016/2369 Phase 2 · George Institute for · pediatric cancer
  5. FUTURE Phase 2 · George Institute for · Colorectal cancer
  6. TAS-120-203 Phase 2 · Taiho Pharma Canada · Advanced or Metastatic Urothelial Carcinoma
  7. TAS-120-206 Phase 2 · Taiho Pharma Canada · Solid Tumors
  8. VHIO17002 Phase 2 · George Institute for · Subjects with advanced solid tumour

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is futibatinib?

futibatinib (LYTGOBI) is a fibroblast growth factor receptor inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for futibatinib?

LYTGOBI is a marketed brand name for futibatinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of futibatinib?

futibatinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.