Will the FDA approve a psilocybin treatment during 2026?

This market predicts whether the U.S. Food and Drug Administration (FDA) will grant approval for a psilocybin-containing therapy for any clinical indication during calendar year 2026. If, in this period, the FDA grants marketing approval (including standard, accelerated, or priority review approval) to a drug product whose active pharmaceutical ingredient is psilocybin for any human clinical indication, this market will resolve to "Yes". Otherwise, it will resolve to "No". The Primary Designated Source is the FDA Drug Approvals database and the FDA Orange Book.

Breakthrough Therapy designation, Fast Track designation, end-of-Phase consultations, advisory committee recommendations, and Investigational New Drug authorizations do NOT count as approval. Approval requires a final FDA marketing authorization (NDA or BLA approval letter). Approvals for non-human use (veterinary), or expanded-access (right-to-try) authorizations, do not count. State-level decriminalization or therapeutic-use programs do not count. A consensus of credible reporting may confirm the official outcome. In ambiguous edge cases, resolution will follow the spirit of the question.