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Drug

Vemurafenib

Established medicine

Primarily used for Melanoma.

ClassSerine/threonine-protein kinase B-raf inhibitorResearchActive indication expansion

Also known as Zelboraf, Vémurafénib, Vemurafenibum.

RxNorm1147220ChEMBLCHEMBL1229517ATCL01EC01UNII207SMY3FQT
4
Research papers
19
Active clinical trials
BRAF
Primary target
18
Regulatory events
Latest activity
beta

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

A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia

Clinical trial2026-08-24Results expected Q1 2027 · ClinicalTrials.gov

Label change: VEMURAFENIB (NDA202429)

Regulatory2026-08-20FDA

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer

Clinical trial2026-08-11Results expected Q4 2026 · ClinicalTrials.gov

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

Clinical trial2026-07-24Results expected Q3 2028 · ClinicalTrials.gov

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Clinical trial2026-07-24Results posted · ClinicalTrials.gov

Label change: VEMURAFENIB (NDA202429)

Regulatory2020-05-18FDA

Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial.

Research2018-03-21The Lancet. Oncology

Indication expansion: VEMURAFENIB (NDA202429)

Regulatory2017-11-06FDA

Indication expansion: VEMURAFENIB (NDA202429)

Regulatory2017-09-13FDA

Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations.

Research2015-08-01The New England journal of medicine

Improved overall survival in melanoma with combined dabrafenib and trametinib.

Research2014-11-16The New England journal of medicine

Improved survival with vemurafenib in melanoma with BRAF V600E mutation.

Research2011-06-05The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name
Vemurafenib
Aliases & brands
ZelborafVémurafénibVemurafenibum
RxNorm CUI
1147220
ChEMBL ID
CHEMBL1229517
ATC codes
L01EC01
UNII
207SMY3FQT
Primary mechanism
Serine/threonine-protein kinase B-raf inhibitor
Regulatory jurisdictions
emamhrafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Serine/threonine-protein kinase B-raf
BRAF · P15056
INHIBITORSerine/threonine-protein kinase B-raf inhibitor

Regulatory timeline

18 events

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.

Approval / market entry confirmed across FDA and EMA (2011-08-17 → 2012-02-17)
Earliest approval
2011-08-17
Latest approval
2017-11-06
Authorities
FDA · EMA · MHRA
Total events
18
fdaU.S. Food and Drug Administration· 16 events
2026-08-20Label change
Label change: VEMURAFENIB (NDA202429)
Evidence ↗
2020-05-18Label change
Label change: VEMURAFENIB (NDA202429)
Evidence ↗
2017-11-06Indication expansion
Indication expansion: VEMURAFENIB (NDA202429)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2012-02-17ApprovalMulti-authority
Approval: Zelboraf (EMA)

Indication: Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2015-11-12Safety communicationSafety
Drug Safety Update: Vemurafenib (Zelboraf▼): risk of potentiation of radiation toxicity
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

117 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
117
registered trials across all phases
LATEST COMPLETION 2025
19
Active studies
9
Recruiting
15
Late-stage (III+)
58
Completed
40
Discontinued
PHASE DISTRIBUTIONn = 117
Early Phase 13Phase 138Phase 1 / 27Phase 254Phase 2 / 32Phase 39Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

CompletedPH IVHoffmann-La Rochen=2152020

An Open-Label, Single-Arm, Multicenter Study To Assess The Safety Of Vemurafenib In Patients With Braf V600 Mutation Positive Metastatic Melanoma In South Africa.

CompletedPH IVHoffmann-La Rochen=602019

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

RecruitingPH II/IIICancer Research UKn=302029

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

Active, not recruitingPH IIIKey trialHoffmann-La Rochen=1,0002028

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

Active, not recruitingPH II/IIIKey trialHoffmann-La Rochen=1,0002026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity - DARWINII

CompletedPH IIUniversity College, Londonn=502025

A Phase II Clinical Trial of Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma

CompletedPH IIH. Lee Moffitt Cancer Center and Research Instituten=172025

Pediatric Neuro-Oncology Consortium (PNOC)-002: Safety, Phase 0, and Pilot Efficacy Study of Vemurafenib, an Oral Inhibitor of BRAFV600E, in Children and Young Adults With Recurrent/Refractory BRAFV600E- or BRAF Ins T Mutant Brain Tumors

CompletedPH IUniversity of California, San Franciscon=402025

Neoadjuvant Therapy for Patients With High Risk Stage III Melanoma: A Pilot Clinical Trial

CompletedPH IIMayo Clinicn=642025

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Vemurafenib in Patients With Tumors Harboring BRAF V600 Mutations

CompletedPH IINational Cancer Institute (NCI)n=42024

Continuous ReAssessment With Flexible ExTension in Rare Malignancies - CRAFT: The NCT-PMO-1602 Phase II Trial

CompletedPH IIGerman Cancer Research Centern=722024

Research activity

4 papers

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

Publications over time
20112018
Major research themes1
Mutation2
Journals, researchers & institutions
Top journals
  • The New England journal of medicine3
  • The Lancet. Oncology1
Leading researchers
  • Dummer R3
  • Robert C3
  • Schadendorf D3
  • Chiarion-Sileni V2
  • Flaherty KT2
  • Garbe C2
  • Hauschild A2
  • Krajsova I2
Leading institutions
free-text, unnormalised
  • Cancer Center1
  • Centre Hospitalier Universitaire de Bordeaux1
  • From Memorial Sloan Kettering Cancer Center1
  • Hospital Clinic of Barcelona1
  • Memorial Sloan-Kettering Cancer Center1
  • National and Kapodistrian University of Athens1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications
Melanoma3
Active research areas
Skin Neoplasms2

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Encorafenib

Acts on the same molecular target as Vemurafenib, with 2 overlapping disease areas.

Shared target2 shared diseases1 shared paper
Binimetinib

Studied across 2 of the same disease areas as Vemurafenib in the shared literature.

2 shared diseases1 shared paper
Dabrafenib

Studied across 2 of the same disease areas as Vemurafenib in the shared literature.

2 shared diseases1 shared paper
Dacarbazine

Studied across 2 of the same disease areas as Vemurafenib in the shared literature.

2 shared diseases1 shared paper
Trametinib

Studied across 2 of the same disease areas as Vemurafenib in the shared literature.

2 shared diseases1 shared paper
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.