BRAF V600D Inhibitors
1 drugsAbout BRAF V600D
BRAF V600D is a mutated form of the BRAF protein, a key signaling molecule in the RAS/MAPK pathway that controls cell growth and differentiation. Its constitutive activation drives uncontrolled cell proliferation, making it an important target in oncology.
The rationale for targeting BRAF V600D stems from its prevalence in various cancers. However, there is currently no genetic evidence directly linking BRAF V600D to specific diseases in this dataset.
There is one FDA-approved drug, TAFINLAR (Novartis), targeting BRAF V600D for oncology indications. TAFINLAR, a small molecule, was first approved in 2013.
Top BRAF V600D Drugs
Novartis is the only company with an approved drug targeting BRAF V600D.
The lack of competition suggests a high barrier to entry or an untapped market opportunity.
BRAF V600D Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets BRAF V600D, using small molecule modality.
Exploring alternative modalities like antibodies or PROTACs could provide a competitive advantage.
BRAF V600D Clinical Trials 93 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on BRAF V600D. 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 | - |
Top Sponsors
By Modality
Top Conditions
Top Drugs
BRAF V600D Drug Approval Timeline (2013 - 2013)
The first and only drug, TAFINLAR, was approved in 2013.
The approval timeline suggests potential saturation, requiring novel approaches for future 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 V600D. A trial counts if an approved drug acting on BRAF V600D 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.