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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).
