FDA psilocybin development updates: what's happening with NDA filings
178 replies · News & Current Events
COMPASS Pathways received Breakthrough Therapy designation, Usona Institute is in Phase 3, several other companies have clinical programs ongoing. Can someone give a clear picture of where things actually stand with FDA pathways and realistic timelines?
COMPASS Pathways' COMP360 is in Phase 3 for treatment-resistant depression. Enrollment is ongoing. Even under optimistic assumptions, we're looking at an NDA submission no earlier than 2026-2027 and approval (if it comes) after a review period.
Usona's program is further along in some respects: they're in Phase 3 with MDD (not treatment-resistant) as the indication. The Phase 3 data is being collected now. Timeline similarly 2026-2028 for any potential approval.
What FDA approval would actually mean: a prescription drug that can be administered in licensed clinical settings with specifically trained therapists. Not legal for recreational use. Not immediately available everywhere. But a major step in normalization and access.
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