Drug · Small Molecule
Vemurafenib
CI-DRUG-00000635Explore in graph →NCIt C64768 CHEMBL1229517 CIViC Approved
Regulatory
Approvals (9)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2017-11-06 (see label) | approved | Nov 6, 2017 | openfda |
| US FDA | — | Efficacy supplement 2017-09-13 (see label) | approved | Sep 13, 2017 | openfda |
| US FDA | — | Efficacy supplement 2016-08-31 (see label) | approved | Aug 31, 2016 | openfda |
| US FDA | — | Efficacy supplement 2014-03-19 (see label) | approved | Mar 19, 2014 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 18 | 7 | 11 | 116 | 9 | CA, EU, US | Aug 17, 2011 | 2006-11 |
| Malignant Thyroid Gland Neoplasm | Phase3 | Phase 3 | 4 | 2 | 1 | 7 | 0 | — | — | Nov 7, 2012 |
| Non-Hodgkin Lymphoma | Phase3 | Phase 3 | 4 | 2 | 1 | 8 | 0 | — | — | Apr 12, 2012 |
| Malignant Lung Neoplasm | Phase3 | Phase 3 | 3 | 2 | 2 | 5 | 0 |
Curated evidence
Clinical evidence (261)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 23406047
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| BRAF V600E8 | ||||||||
| Radiation Therapy + Vemurafenib | ||||||||
Clinical trials
Trials with this intervention (119)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT01657591 | Study of XL888 With Vemurafenib for Patients With Unresectable BRAF Mutated Stage III/IV Melanoma | completed | Phase 1 | 21 | H. Lee Moffitt Cancer Center and Research InstituteOTHER | 1 | Jan 19, 2023 | clinicaltrials |
| NCT02052193 | Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study | terminated |