BRAF B-Raf proto-oncogene, serine/threonine kinase
ENSG00000157764 · protein coding · Open Targets profile
Protein kinase involved in the transduction of mitogenic signals from the cell membrane to the nucleus (Probable). Phosphorylates MAP2K1, and thereby activates the MAP kinase signal transduction pathway (PubMed:21441910, PubMed:29433126). Phosphorylates PFKFB2 (PubMed:36402789). May play a role in the postsynaptic responses of hippocampal neurons (PubMed:1508179). {ECO:0000269|PubMed:1508179, ECO:0000269|PubMed:21441910, ECO:0000269|PubMed:29433126, ECO:0000269|PubMed:36402789, ECO:0000305}.
Each band is a group of drugs. It runs from the kind of drug on the left to the furthest stage that drug has reached in any disease on the right. Thicker bands mean more drugs.
Approved bands are highlighted. Withdrawn means the drug was pulled from the market or from development. A combined phase counts as the later one (Phase 1/2 is shown as Phase 2). Hover a band for the drug names. Source: Open Targets Platform, fetched live.
Each row is a cancer, strongest overall evidence first. The two dots show how strong the inherited (germline) and tumour-mutation (somatic) evidence is; the line between them is the gap.
Scores run from 0 (no evidence) to 1 (strongest). A missing dot at 0 means Open Targets holds no evidence of that kind. Source: Open Targets Platform, fetched live.
Tractability
- Small molecule
- Approved Drug, Structure with Ligand, High-Quality Ligand, High-Quality Pocket, Druggable Family
- Antibody
- UniProt loc high conf, GO CC high conf, Human Protein Atlas loc
- PROTAC
- Literature, UniProt Ubiquitination, Database Ubiquitination, Half-life Data, Small Molecule Binder
gnomAD loss of function constraint: o/e 0.15297000110149384 (upper bound 0.2323399931192398). Low values mean loss of function is poorly tolerated, a safety flag for inhibition.
Who runs trials of these drugs
Principal investigators and study chairs on 400 registry trials, updated in the last three years, of the most advanced drugs against BRAF (tovorafenib, dabrafenib, sorafenib, regorafenib, encorafenib, vemurafenib, naporafenib, belvarafenib, plixorafenib, RAF-265), ranked by Phase 2+ trials. Live from ClinicalTrials.gov.
- Eric ShermanMemorial Sloan Kettering Cancer Center · 3 of 3 trials Phase 2+
- Matthew KrebsThe Christie Hospital · 3 of 3 trials Phase 2+Ph2/Ph3NCT07440290 · DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.brief
- Nicolas PenelCentre Oscar Lambret · 3 of 3 trials Phase 2+
- Jean-Yves BLAYCentre Leon Berard · 2 of 3 trials Phase 2+Ph2NCT02029001 · Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatmentbrief
- Joyce AntalClinical Development · 2 of 3 trials Phase 2+
- Emmanuelle SAMALINCRLC Val d'Aurelle-Paul Lamarque · 2 of 2 trials Phase 2+
- Ghassan Abou-AlfaMemorial Sloan Kettering Cancer Center · 2 of 2 trials Phase 2+
- Jae ParkMemorial Sloan Kettering Cancer Center · 2 of 2 trials Phase 2+
- Kanwal RaghavM.D. Anderson Cancer Center · 2 of 2 trials Phase 2+
- Kefeng DingSecond Affiliated Hospital, Zhejiang University, School of Medicine · 2 of 2 trials Phase 2+
- Lin ShenPeking University Cancer Hospital & Institute · 2 of 2 trials Phase 2+
- Mikhail FedyaninBlokhin's Russian Cancer Research Center · 2 of 2 trials Phase 2+
- Ryan J SullivanMassachusetts General Hospital · 2 of 2 trials Phase 2+
- Van K MorrisM.D. Anderson Cancer Center · 2 of 2 trials Phase 2+
- Ying YuanSecond Affiliated Hospital, Zhejiang University, School of Medicine · 2 of 2 trials Phase 2+
Registry trials of tovorafenib, dabrafenib, sorafenib, regorafenib, encorafenib, vemurafenib, naporafenib, belvarafenib, plixorafenib, RAF-265 updated in the last three years, counted by the country group of their listed sites. A trial with sites in several groups counts in each; 281 of 379 have all sites in one country.
Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where sites are is a fact about the record, not a judgement of its quality. Europe is the EU and EEA, the UK and Switzerland. 21 trials list no sites and are left out. Source: ClinicalTrials.gov, fetched live.
289 trials of drugs against BRAF were stopped early; 20 of the 200 most recent give no reason
Terminated, withdrawn and suspended interventional trials of tovorafenib, dabrafenib, sorafenib, regorafenib, encorafenib, vemurafenib, naporafenib, belvarafenib, plixorafenib, RAF-265, XL-281, lifirafenib, newest update first, live from ClinicalTrials.gov. Each reason is quoted exactly as the registry gives it; we do not sort reasons into safety, efficacy or business. Dates are the last registry update. Showing the 25 most recent of 289.
- terminated · 2026-11-03 · Peking University Cancer Hospital & Institute · regorafenib“The study was stopped early due to lack of efficacy.”
- suspended · 2026-10-20 · City of Hope Medical Center · Regorafenib“resources”
- suspended · 2026-10-15 · City of Hope Medical Center · Dabrafenib“Accrual goal met”
- terminated · 2026-10-06 · ECOG-ACRIN Cancer Research Group · Dabrafenib mesylate“Slow accrual”
- terminated · 2026-10-06 · ECOG-ACRIN Cancer Research Group · Encorafenib“Slow accrual”
- terminated · 2026-10-05 · Children's Oncology Group · Regorafenib“Drug supply issues”
- terminated · 2026-08-26 · Bristol-Myers Squibb · RegorafenibNo reason given
- terminated · 2026-07-06 · Syndax Pharmaceuticals · matched by the registry's drug synonyms“Study was terminated by sponsor after Phase 1b as pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort.”
- withdrawn · 2026-06-15 · University of Miami · Regorafenib“Investigator decision”
- terminated · 2026-06-12 · Northwestern University · Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab“The study was closed due to accrual.”
- terminated · 2026-06-04 · Pfizer · encorafenib“The study was prematurely discontinued due to strategic reasons. The PF-07284892 program will continue”
- withdrawn · 2026-04-21 · SRH Wald-Klinikum Gera GmbH · Encorafenib & Binimetinib Treatment“The study was terminated early due to insufficient patient recruitment.”
- withdrawn · 2026-03-11 · M.D. Anderson Cancer Center · Regorafenib“0 participants enrolled”
- terminated · 2026-03-09 · Translational Research in Oncology · Regorafenib in combination with pembrolizumab“The trial ended earlier than planned due to slow enrolment, which has made it unfeasible to achieve the target sample size within a reasonable timeframe. Consequently, a business decision has been made to discontinue funding for the trial.”
- terminated · 2026-03-09 · Pfizer · encorafenib“Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.”
- terminated · 2026-03-05 · Wake Forest University Health Sciences · Regorafenib“Slow accruals”
- withdrawn · 2026-02-25 · M.D. Anderson Cancer Center · Regorafenib“0 participants enrolled”
- terminated · 2026-01-20 · Anwaar Saeed · Regorafenib“Terminated per directive from Bayer due to funding.”
- terminated · 2026-01-09 · Pfizer · Encorafenib“Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions”
- terminated · 2025-12-24 · Novartis Pharmaceuticals · Dabrafenib“The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.”
- suspended · 2025-10-23 · Mirror Biologics, Inc. · Sorafenib“Sponsor unable to fund”
- terminated · 2025-10-02 · Day One Biopharmaceuticals, Inc. · Tovorafenib“Sponsor decision”
- terminated · 2025-09-18 · Novartis Pharmaceuticals · Dabrafenib“Sponsor decision”
- suspended · 2025-09-03 · JS InnoPharm, LLC · Dabrafenib“Sponsor decision”
- terminated · 2025-08-19 · Mayo Clinic · Dabrafenib“Financial issues”
Paediatric incentives and obligations for BRAF's drugs
For tovorafenib, dabrafenib, sorafenib, regorafenib, encorafenib, vemurafenib, naporafenib, belvarafenib, plixorafenib, RAF-265, XL-281, lifirafenib: what EMA and FDA publish about paediatric plans, orphan status and pediatric approvals, and how many registered studies take children. Each line is a yes, no or not published fact from the record linked under it; none of it is a forecast.
- FDA pediatric target list: yes · BRAF is on the list. Membership alone neither requires nor waives a pediatric study.Rule: Target is on FDA's Pediatric Molecular Target List (relevant targets). Source: FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01)), 2026-11-11
- EU paediatric investigation plan: yes · EMA/PE/0000182170 (regorafenib, Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)): PM: decision on the application for modification of an agreed PIP, 5 Dec 2024; EMEA-002763-PIP01-20-M01 (tovorafenib, Treatment of paediatric low grade glioma): PM: decision on the application for modification of an agreed PIP, 27 Oct 2023; EMEA-001588-PIP04-23 (Encorafenib, Treatment of lung cancer): W: decision granting a waiver in all age groups for all conditions or indications, 8 Sept 2023; EMEA-001588-PIP01-13-M03 (Encorafenib, Treatment of melanoma): PM: decision on the application for modification of an agreed PIP, 21 Apr 2023; compliance positive 26 Apr 2024; +5 moreRule: An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name. Source: EMA data download (dated snapshot), 2026-11-11
- EU orphan designation: yes · EU/3/21/2434 positive 20 May 2021: Treatment of glioma; EU/3/13/1200 expired 13 Nov 2013: Treatment of papillary thyroid cancer; EU/3/13/1199 expired 13 Nov 2013: Treatment of follicular thyroid cancer; EU/3/20/2372 positive 9 Dec 2020: Treatment of glioma; +6 moreRule: An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status. Source: EMA data download (dated snapshot), 2026-11-11
- Authorised in the EU: yes · Braftovi: authorised since 19 Sept 2018; Tafinlar: authorised since 26 Aug 2013; Ojemda: authorised since 20 Apr 2026, orphan medicine, conditional; Sorafenib Accord: authorised since 9 Nov 2022; +4 moreRule: An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file. Source: EMA data download (dated snapshot), 2026-11-11
- FDA orphan designation: not published · FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the linkRule: Would be: an FDA orphan designation names the drug. Source: FDA orphan designations search
- FDA pediatric oncology approval: yes · Tovorafenib [Ojemda], 23 Apr 2024: Treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation; Dabrafenib [Tafinlar], 31 Aug 2023: In combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options; Dabrafenib [Tafinlar], 16 Mar 2023: In combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapyRule: FDA's Pediatric Oncology Drug Approvals table names the drug. Source: FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03), 2026-11-11
- Registered studies open to children: yes · 123 interventional studies of tovorafenib, dabrafenib, sorafenib, regorafenib, encorafenib, vemurafenib, naporafenib, belvarafenib, plixorafenib, raf-265, xl-281, lifirafenib include patients under 18; 51 are recruiting, not yet recruiting or activeRule: The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age. Source: ClinicalTrials.gov search, 2026-11-11
Rare pediatric disease voucher. FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news. FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs
All 18 drugs and clinical candidates as a table
Each drug, stage and indication links to its Open Targets record, where the trials and approvals behind it are listed. Salt forms (for example a mesylate) are listed as Open Targets records them, as separate entries.