While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
The FDA followed up President Donald Trump’s April 18 executive order on Friday, awarding Commissioner’s National Priority Vouchers to three companies developing psychedelic therapies.
The FDA did not disclose the specific companies to receive Commissioner’s National Priority Vouchers (CNPVs) in its Friday morning release and declined to comment on the record when contacted by BioSpace.
However, it did say in its Friday release that the recipients are developing psilocybin for treatment-resistant depression (TRD), psilocybin for major depressive disorder (MDD) and methylone for post-traumatic stress disorder (PTSD).
Shortly after the FDA announcement, Compass Pathways issued a press release announcing that it had received one of the vouchers for its psilocybin-based candidate COMP360 for TRD. The FDA also approved Compass’ new drug rolling review request in post-traumatic stress disorder (PTSD).
Meanwhile, the other two voucher recipients remain undisclosed, though a few companies match up with the agency’s descriptions. Transcend Therapeutics, for example, is developing methylone-based TSND- 201 for PTSD. TSND-201 received the agency’s Breakthrough Therapy designation in July 2025—a requirement stated in the president’s executive order for the three expected CNPVs. At the time, Transcend was in the process of initiating a Phase 3 trial.
There’s also Usona Institute, which received the FDA’s Breakthrough Therapy designation in 2019 for its psilocybin-based candidate designed to treat MDD.
Notably, none of the listed products match those in development at Definium Therapeutics, which was widely believed to be in the running for one of the priority review vouchers. Definium’s lead candidate DT120 is a pharmaceutically optimized formulation of lysergide (LSD) D-tartrate in Phase 3 trials for MDD and generalized anxiety disorder. The company has an earlier-stage MDMA-based asset in Phase 2 development for autism spectrum disorder.
Friday’s update follows an executive order signed by Trump last Saturday morning in the Oval Office. The order, which is aimed at accelerating the development of and facilitating broader access to psychedelic therapies for serious mental health conditions, instructed the FDA to grant three CNPVs to psychedelics in development that also hold Breakthrough Therapy designation. The priority voucher program, announced in June 2025, aims to shorten review times for products that meet national priorities down to 1–2 months from the usual 10–12 months.
“There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement on Friday. “At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today’s actions.”
While the reaction to this new psychedelic therapies push has been largely positive, some experts have questioned, in particular, its origin. The executive order came about after Joe Rogan sent Trump information on the benefits of ibogaine—a particularly tricky psychedelic—for opioid use disorder, the pundit said during Saturday’s signing. Rogan recalled Trump’s response: “Sounds great. You want FDA approval, let’s do it.”
Holly Fernandez Lynch, associate professor of Medical Ethics and Law at the University of Pennsylvania, pointed to this as a particular point of concern.
“What Trump was saying around the executive order during the press conference was kind of mind blowing,” she told BioSpace on Monday. “Like this idea that his buddies could just send him a text and he’ll offer them FDA approval is not acceptable.”
In addition to the CNPVs, the FDA intends to release final guidance “imminently” to sponsors regarding the development of psychedelics. “Designing clinical trials to evaluate serotonin-2A agonists [a class to which psychedelics belong] and related products presents unique scientific and methodological challenges,” according to the release.