The FDA has announced the winners of national priority vouchers to study psychedelic drugs for mental health treatment, following President Trump’s executive order accelerating research into these therapies. Three companies received vouchers to study serotonin-2A agonists for treatment-resistant depression, alcoholism and other serious mental health conditions, while another company was granted permission to begin clinical trials on noribogaine hydrochloride for alcohol use disorder.
Compounds Under Study
FDA Commissioner Dr. Marty Makary noted these medications “have the potential to address the nation’s mental health crisis,” according to the announcement. Psilocybin is being studied by Compass Pathways, the nonprofit Usona Institute and pharmaceutical company Transcend Therapeutics. Compass Pathways’ Phase 3 trial data showed patients can see symptom relief in as little as one day and for up to six months with only one or two doses. Methylone, which imitates MDMA, is also under investigation for post-traumatic stress disorder.
Concerns About Process
While industry leaders praised the accelerated timeline, skepticism emerged from observers. Dan Troy, former FDA chief legal counsel, warned that “the White House giving priority directives to the FDA is an unprecedented move” that could raise doubts about the agency’s independence and dedication to historically rigorous, apolitical processes. He noted concerns about whether people would trust medicines approved through this pathway.
Next Steps
The FDA clarified that priority vouchers do not mean drugs will come to market faster or that they have been approved. The agency will continue reviewing data as it becomes available. FDA Commissioner Makary noted some drugs could hit the market as soon as summer or fall, depending on trial status and data outcomes. Availability will depend on insurance coverage, price, distribution and regulation.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.usatoday.com/story/news/health/2026/04/24/what-psychedelics-fda-trump-approve-for-study/89774878007/