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Following last week’s executive order that directed federal agencies to speed research and loosen restrictions on psychedelics, the Food and Drug Administration (FDA) announced it will fast-track review of three psychedelic drugs being developed to treat mental health.
The details: FDA awarded priority review vouchers to Compass Pathways’ psilocybin product for treatment-resistant depression, Usona Institute’s psilocybin treatment for major depressive disorder, and Transcend Therapeutic’s methylone (MDMA-like) treatment for post-traumatic stress disorder.
- The vouchers don’t guarantee approval but mean regulators will try to shorten their reviews from a period of months to weeks.
Plus: In a separate move, FDA authorized initial testing of a drug related to ibogaine for people with alcohol use disorder, allowing DemeRx to begin a first-in-human study of the dug.
What’s coming: FDA also intends to release final guidance to provide recommendations to sponsors developing psychedelic products, including related to study design, data collection and generation, patient monitoring, and conducting adequate and well-controlled clinical investigations.
Read more: FDA plans ultra-fast review of three psychedelic drugs following Trump directive; FDA to speed up review of three psychedelics as mental health treatments
Published
April 2026