Friday, July 10, 2026

Drug profile · INN

vemurafenib

vemurafenib (ZELBORAF) is a serine/threonine-protein kinase b-raf inhibitor. Associated with Hoffmann-La Roche. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EC01
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — vemurafenib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
8
Data quality
0.84

Quick answer

vemurafenib (ZELBORAF) is a serine/threonine-protein kinase b-raf inhibitor. Associated with Hoffmann-La Roche. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN vemurafenib
Brand ZELBORAF
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 TABLET
ATC code L01EC01

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
NMPA clinical trials

Pipeline programs

  1. BO40729 Phase 3 · HOFFMANN-LA ROCHE · Advanced Malignancies
  2. Vemurafenib Phase 3 · HOFFMANN-LA ROCHE · Malignant Melanoma
  3. NEO-TIM Phase 2 · Telethon Foundation · high-risk, surgically resectable BRAF mutated and wild-type
  4. Zelboraf 240 mg film-coated tablets Phase 2 · Ningbo Cancer Hospital · Patients with metastatic or unresectable locally advanced ma
  5. 14341 Phase 1 · Disc Medicine · Glioma
  6. Vemurafenib Oral Tablet [Zelboraf] Phase 1 · Chinese Academy of · BRAF V600E-mutated /MSS Metastatic Colorectal Cancer
  7. C4221026 Approved · First Biotech (Australia) · Solid tumors
  8. Vemurafenib Approved · HOFFMANN-LA ROCHE · Neoplasms

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 vemurafenib?

vemurafenib (ZELBORAF) is a serine/threonine-protein kinase b-raf inhibitor. Associated with Hoffmann-La Roche. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for vemurafenib?

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

What is the US approval status of vemurafenib?

vemurafenib 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.