FDA moves to fast-track review of psilocybin and methylone for mental health
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By Jacqueline Howard
Published on April 24, 2026.
The US Food and Drug Administration (FDA) has initiated a fast-track review of psychedelic drugs, psilocybin and methylone, potentially being approved for use as mental health treatments in the US. The vouchers were granted under the FDA Commissioner’s National Priority Voucher pilot program, which aims to expedite the review process for certain drugs and biological products seeking approval. The agency also allows an early phase clinical study of a drug based on the psychedelic ibogaine as a potential treatment for alcohol use disorder to proceed, marking the first time the FDA has allowed a clinical study in the United States of the drug. This follows an executive order signed by President Donald Trump directing the FDA to prioritise psychedelic drugs granted “breakthrough therapy” status. The FDA also plans to release final guidance to advise sponsors developing these products.
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