Some psychedelic drugs, once considered fringe treatments, are moving closer to possible FDA approval for mental health use in the United States. The FDA issued national priority vouchers to three companies studying psilocybin—the active ingredient in “magic mushrooms”—for treatment-resistant depression and major depressive disorder, and methylone, similar to MDMA, for post-traumatic stress disorder.
Priority Voucher Program Details
The vouchers were granted under the FDA Commissioner’s National Priority Voucher pilot program, launched last year to fast-track review for certain drugs and biological products. The companies awarded vouchers are Compass Pathways, the Usona Institute, and Transcend Therapeutics. Compass Pathways has been studying a proprietary formulation of synthetic psilocybin for treatment-resistant depression. CEO Kabir Nath stated in a news release that “Compass has generated positive data from two large, well controlled Phase 3 clinical trials.” The Usona Institute said the voucher “accelerates FDA review to approximately one to two months,” but “it does not alter scientific or regulatory standards.”
Broader Context and Expert Perspectives
The FDA also is allowing an early-phase clinical study of a drug based on ibogaine as a potential treatment for alcohol use disorder—the first instance the agency has allowed a U.S. clinical study of the drug derived from the African Tabernanthe iboga plant. President Trump signed an executive order directing FDA Commissioner Marty Makary to prioritize psychedelic drugs granted “breakthrough therapy” status and calling for accelerating both research and access, including a $50 million investment in state governments to study psychedelics’ benefits for mental health. The American Psychiatric Association welcomes federal investment in psychedelic research but emphasizes that current scientific evidence is not sufficient for use outside approved research settings without rigorous clinical trial data evaluating risks versus benefits.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://ktvz.com/health/cnn-health/2026/04/24/fda-moves-to-fast-track-review-of-psilocybin-and-methylone-for-mental-health/