Wednesday, July 8, 2026

Drug profile · INN

encorafenib

encorafenib (BRAFTOVI) is a serine/threonine-protein kinase b-raf inhibitor. Associated with Pierre Fabre Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01EC03
US status approved
Patents linked 0
Pipeline programs 16
News articles 0
Drug details — encorafenib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
16
Data quality
0.84

Quick answer

encorafenib (BRAFTOVI) is a serine/threonine-protein kinase b-raf inhibitor. Associated with Pierre Fabre Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN encorafenib
Brand BRAFTOVI
Mechanism Serine/threonine-protein kinase B-raf inhibitor
Target Serine/threonine-protein kinase B-raf
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EC03

Mechanism of action

Serine/threonine-protein kinase B-raf inhibitor

Primary target: Serine/threonine-protein kinase B-raf

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. C4221015 Phase 3 · First Biotech (Australia) · Colorectal cancer (BRAF V600E-mutant mCRC)
  2. C4221016 Phase 3 · First Biotech (Australia) · Metastatic or unresectable locally advanced BRAF V600E/K mut
  3. IMFINZI for Advanced Biliary Cancer (ABC) Phase 3 · Ningbo Cancer Hospital · Advanced Biliary Cancer (ABC)
  4. C4221008 Phase 2 · First Biotech (Australia) · Non-small Cell Lung Cancer
  5. C4221022 Phase 2 · First Biotech (Australia) · MSI-H/dMMR metastatic colorectal cancer
  6. C4221023 Phase 2 · First Biotech (Australia) · Metastatic or unresectable locally advanced BRAF V600E/K mut
  7. ECLYPse Phase 2 · Telethon Foundation · Patients affected by mCRC harbouring BRAF V600E
  8. ENCORAFENIB , CETUXIMAB Phase 2 · George Institute for · Patients with BRAF V600E-mutant metastatic colorectal cancer

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 encorafenib?

encorafenib (BRAFTOVI) is a serine/threonine-protein kinase b-raf inhibitor. Associated with Pierre Fabre Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for encorafenib?

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

What is the US approval status of encorafenib?

encorafenib 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.