KIT D816V Inhibitors
1 drugsAbout KIT D816V
KIT D816V is a mutated receptor tyrosine kinase that drives uncontrolled cell proliferation by remaining constitutively active. The mutation, where aspartic acid is replaced by valine at position 816, leads to continuous signaling. This dysregulation is particularly relevant in systemic mastocytosis.
KIT D816V is a drug target in systemic mastocytosis, though no genetic evidence directly links it to specific diseases. The presence of an approved drug targeting this mutation highlights its therapeutic importance. Further research may reveal additional opportunities.
AYVAKIT (avapritinib) is the only FDA-approved drug targeting KIT D816V, developed by BLUEPRINT MEDICINES. It is a small molecule therapy approved in 2020 for systemic mastocytosis, with 6 indications.
Top KIT D816V Drugs
BLUEPRINT MEDICINES is the only company with an approved drug targeting KIT D816V.
The market is highly concentrated, indicating high barriers to entry or limited innovation.
KIT D816V Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets KIT D816V, using small molecule modality.
Exploring alternative modalities like antibodies could provide differentiation.
KIT D816V Clinical Trials 17 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on KIT D816V. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 6 | 4 | 0 | 2 | 100% |
| Phase 2 | 8 | 1 | 0 | 7 | 100% |
| Phase 3 | 1 | 1 | 0 | 0 | 100% |
| Phase 4 | 2 | 1 | 0 | 1 | 100% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
KIT D816V Drug Approval Timeline (2020 - 2020)
The first and most recent drug approval was AYVAKIT in 2020.
Recent approval suggests potential for follow-on innovation, but also market saturation.
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Deep insights for drug target analysis
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: 8 (1 company)
- • 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 KIT D816V. A trial counts if an approved drug acting on KIT D816V 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.