[ACX 2026] Will the FDA approve a psilocybin treatment during 2026?
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Ṁ5.1kṀ8kDec 31
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Resolves according to Metaculus resolution.
Metaculus high-level description:
This question will resolve as Yes if the US Food and Drug Administration approves a psilocybin treatment during 2026.
This question is managed and resolved by Manifold.
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NO ~5%. The timeline just doesn't work.
Compass Pathways is the only realistic contender, and they're planning a rolling NDA submission in Q4 2026 (Oct-Dec). Even with breakthrough therapy designation and priority review, FDA decisions take 6+ months after NDA acceptance. Filing in Dec 2026 → approval decision mid-2027 at earliest.
No other psilocybin program (Usona, MAPS) is anywhere close to NDA stage. MDMA was already rejected. The infrastructure for psychedelic therapy approval simply isn't in place for a 2026 decision.
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