Is psilocybin FDA-approved? Status in November 2026

No. As of November 8, 2026, no psilocybin medicine is FDA-approved, and psilocybin remains a federal Schedule I drug.

Compass Pathways said on November 3, 2026 that it will complete its new drug application for COMP360 psilocybin for treatment-resistant depression within two weeks, citing two positive Phase 3 trials. It expects a launch in the first half of 2027 if approved, and holds an FDA priority voucher that targets a one-to-two-month review.

Usona Institute reportedly completed an application for its psilocybin for major depressive disorder, according to a November 2 Psychedelic Alpha report. Usona declined to comment and the FDA has not confirmed it, so treat it as unconfirmed.

An approval would cover one specific product for one condition, prescribed under FDA rules, likely with a safety program similar to Spravato's, which requires certified clinics and on-site monitoring. The DEA would also need to reschedule the product before it could be sold. It would not legalize psilocybin mushrooms or change state laws.

Oregon and Colorado run state-regulated psilocybin programs for adults, and New Mexico has passed a medical psilocybin law. Our state-by-state law pages list the current status with official sources.