At least one psychedelic compound — most likely COMPASS Pathways COMP360 — will receive FDA approval or formal approval recommendation before end of 2027.

COMPASS Pathways' psilocybin compound COMP360 is on track to become the first psychedelic drug approved by the FDA, likely for treatment-resistant depression — meaning millions of people who don't respond to antidepressants would have a new legal option.

COMP360 achieved Phase 3 primary endpoint for TRD. FDA issued National Priority Voucher. FDA Commissioner Makary expects decision by late summer/fall 2026. Breakthrough Therapy designation + Phase 3 success + Priority Voucher + Commissioner statement = approval is base case. 87% reflects residual uncertainty around Advisory Committee, label negotiation, REMS.