The FDA has granted Breakthrough Therapy designation to COMP360 psilocybin therapy for treatment-resistant PTSD, accelerating the review pathway after Phase 2b trials showed 58% of participants achieving clinically significant symptom reduction.
Trial Results
The multicenter trial enrolled 320 veterans and first responders with PTSD that had not responded to at least two prior treatments.
- 58% achieved clinically meaningful PTSD symptom reduction at 12-week follow-up
- 34% no longer met diagnostic criteria for PTSD after two guided sessions
- Treatment involves two 6-hour psilocybin sessions with trained therapists
- Side effects were mild: temporary anxiety, headache, nausea during sessions
Regulatory Path
Compass Pathways plans to submit the Phase 3 trial protocol by Q3 2026 with potential FDA approval by late 2027. The VA has signaled willingness to cover the treatment if approved, which would make it accessible to the estimated 500,000 veterans with treatment-resistant PTSD.
