FDA To Fast-track Review of Psilocybin For Mental Health - Addiction/Recovery eBulletin

FOR BETTER OR WORSE –

April 23, 2026 – Some psychedelic drugs, once considered fringe, are getting a step closer to possibly being approved for use as mental health treatments in the United States. The Usona Institute, which has been studying psilocybin for major depressive disorder, said the voucher “accelerates FDA review to approximately one to two months.The FDA also is allowing an early-phase clinical study of a drug based on the psychedelic ibogaine as a potential treatment for alcohol use disorder to move forward. It’s the first instance in which the agency has allowed a clinical study in the United States of the drug, which is derived from the African Tabernanthe iboga plant. However, this move does not mean the drug has been approved or found to be safe or effective, and the agency says it will continue to review data as it becomes available.

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