mutant BRAF Inhibitors
2 drugsAbout mutant BRAF
Mutant BRAF is a mutated form of the BRAF protein, a serine/threonine kinase involved in cell signaling pathways that control cell growth and proliferation. Mutations in the *BRAF* gene can lead to uncontrolled activation of these pathways, driving tumor development.
Mutant BRAF has emerged as a significant oncology target, though no genetic evidence directly links specific *BRAF* mutations to particular diseases in this dataset. The clinical success of drugs targeting mutant BRAF underscores its importance as a therapeutic target.
Two FDA-approved drugs target mutant BRAF: SORAFENIB TOSYLATE (Viatris) and NEXAVAR (Bayer), both small molecules. These drugs have applications in oncology and other therapeutic areas.
Top mutant BRAF Drugs
The competitive landscape includes Viatris and Bayer, the only companies with approved drugs.
Low market concentration suggests opportunities for new entrants, but high barriers to entry.
mutant BRAF Drug Modality Landscape
Modalities
Routes of Administration
mutant BRAF is amenable to small molecule drugs, with oral options available for convenient dosing.
Explore opportunities for novel modalities like antibodies or PROTACs to differentiate from existing therapies.
mutant BRAF Clinical Trials 383 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on mutant BRAF. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 155 | 113 | 33 | 8 | 77% |
| Phase 2 | 168 | 100 | 46 | 21 | 68% |
| Phase 3 | 55 | 36 | 11 | 8 | 77% |
| Phase 4 | 5 | 4 | 1 | 0 | 80% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
mutant BRAF Drug Approval Timeline (2005 - 2020)
The first drug was approved in 2005, with the most recent approval in 2020, spanning 16 years.
The approval timeline indicates a mature target, suggesting potential market saturation.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 2 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 209 (56 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 mutant BRAF. A trial counts if an approved drug acting on mutant BRAF 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.