BRAF V600K Inhibitors
1 drugsAbout BRAF V600K
BRAF V600K is a mutated form of the BRAF protein, a kinase in the MAPK signaling pathway that regulates cell growth and proliferation. The V600K mutation results in constitutive activation of the BRAF kinase, leading to uncontrolled cell growth and tumor development.
BRAF V600K is a target in oncology, though there is currently no genetic evidence data available specifically linking the V600K mutation to diseases in this dataset. The clinical significance of BRAF V600K is highlighted by the existence of targeted therapies.
Tafinlar (dabrafenib) is the only FDA-approved drug targeting BRAF V600K, developed by Novartis for 4 oncology indications. It is a small molecule, and was first approved in 2013.
Top BRAF V600K Drugs
Novartis is the only company with an approved drug targeting BRAF V600K.
High market concentration suggests high entry barriers or limited commercial opportunity.
BRAF V600K Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets BRAF V600K, using small molecule modality.
Explore alternative modalities like antibodies or PROTACs to differentiate from existing therapies.
BRAF V600K Clinical Trials 93 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on BRAF V600K. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 33 | 12 | 13 | 6 | 48% |
| Phase 2 | 49 | 15 | 12 | 22 | 56% |
| Phase 3 | 8 | 4 | 1 | 3 | 80% |
| Phase 4 | 3 | 0 | 0 | 3 | - |
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BRAF V600K Drug Approval Timeline (2013 - 2013)
The first and only drug, Tafinlar, was approved in 2013.
The approval timeline suggests a saturated market, requiring novel approaches for further development.
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Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 1 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 1-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 47 (7 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on BRAF V600K. A trial counts if an approved drug acting on BRAF V600K is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.