The FDA has granted full approval to COMP360, a synthetic psilocybin therapy, for treatment-resistant depression, marking the first psychedelic drug to receive federal approval for mental health treatment in US history.
How It Works
Patients receive a single dose of psilocybin in a supervised clinical setting alongside licensed therapists. The 6-8 hour session is followed by integration therapy over the next several weeks. Clinical trials showed 42% of patients achieved complete remission after a single session.
Access
COMP360 will be available at certified treatment centers starting September 2026. Insurance coverage negotiations are underway, with estimated out-of-pocket costs of $3,000-5,000 per treatment session.
- First FDA-approved psychedelic therapy
- 42% complete remission rate in one session
- Available at certified centers from September
- Cost: $3,000-5,000 per treatment
