FDA issued Commissioner’s National Priority Vouchers to three companies developing psilocybin and methylone therapies Friday, cutting review timelines from 10-12 months to 1-2 months. The agency declined to name two of the three recipients.
Compass Pathways confirmed it received one for COMP360, its psilocybin candidate for treatment-resistant depression. The FDA also approved Compass’ rolling review request for a PTSD indication the same day. The two undisclosed recipients match the agency’s descriptions: a psilocybin developer for major depressive disorder and a methylone developer for PTSD, pointing to Usona Institute and Transcend Therapeutics respectively, though neither has confirmed.
Definium Therapeutics didn’t make the cut. The company’s DT120, an LSD formulation in Phase 3 for MDD and generalized anxiety disorder, didn’t match any of the FDA’s three described indications. It was widely considered a frontrunner.
The CNPVs follow Trump’s April 18 executive order, which directed FDA to grant vouchers to psychedelics holding Breakthrough Therapy designation. That’s the deciding factor: Transcend’s TSND-201 earned it in July 2025. The executive order’s origin story is less reassuring: Joe Rogan sent Trump information on ibogaine, and Trump’s reported reaction was “Sounds great. You want FDA approval, let’s do it.” Holly Fernandez Lynch of the University of Pennsylvania called that framing “kind of mind blowing.”
FDA acting CDER director Tracy Beth Høeg said final clinical trial guidance for psychedelics is coming “imminently.”
— Sarah Chen