Psilocybin will not receive FDA approval for any indication before 2028-09-30.

Psilocybin (the active compound in magic mushrooms) won't receive FDA approval until at least late 2028. This matters because it extends the wait for people with treatment-resistant depression or other conditions who are counting on legal medical access.

No psilocybin NDA is currently on file as of mid-2026. Compass Pathways and Usona are in Phase 3; typical NDA review adds 12–18 months post-submission. Even an optimistic Phase 3 completion by end-2026 implies NDA filing in mid-2027 at earliest, with PDUFA date in late 2028. FDA's post-MDMA posture increases scrutiny probability. This prediction is falsifiable: it resolves YES if FDA approves any psilocybin NDA before 2028-09-30, NO otherwise.