Clinical Trial Success Rates
Historical success rates for clinical trials by development phase, based on primary endpoint achievement data from our database.
| Phase | Total Trials | Successful | Success Rate |
|---|---|---|---|
| N/A | 55 | 25 | 45.5% |
| Phase 1 | 16 | 2 | 12.5% |
| Phase 1/Phase 2 | 18 | 2 | 11.1% |
| Phase 2 | 194 | 73 | 37.6% |
| Phase 2/Phase 3 | 20 | 10 | 50% |
| Phase 3 | 289 | 193 | 66.8% |
| Phase 4 | 24 | 13 | 54.2% |
Understanding Trial Success Rates
Clinical trial success rates vary dramatically by phase and therapeutic area. Industry-wide benchmarks from published research show approximately:
- Phase 1 → Phase 2: ~65% success (primarily safety)
- Phase 2 → Phase 3: ~30-35% (efficacy signal)
- Phase 3 → Approval: ~55-60% (pivotal efficacy)
- Overall (Phase 1 → Approval): ~10-12%
Oncology trials historically have lower success rates (~5% overall), while rare/orphan diseases often have higher rates due to unmet medical need and regulatory flexibility.
Track trial outcomes in real-time
Get AI-powered probability estimates for individual trials based on design quality, endpoint selection, and competitive data.
Start Free Analysis