Full Breakdown
FDA Grants Ultra-Fast Review Vouchers for Three Psychedelic Therapies After Trump Executive Order
4/25/2026, 6:56:40 AM
Ultra-Fast Review Vouchers for Three Psychedelic Candidates
On April 24, 2026 the FDA announced priority review vouchers for three psychedelic therapies: Compass Pathways received a voucher for its psilocybin candidate COMP360 for treatment-resistant depression; Usona Institute got a voucher for a psilocybin therapy for major depressive disorder; and Transcend Therapeutics earned a voucher for a methylone (or methylene) therapy for PTSD. The vouchers aim to cut the six-to-10-month review to one-to-two months. The agency cleared a trial of noribogaine, an ibogaine metabolite from DemeRx NB, for alcohol-use disorder. NAMI reports 23.4 % of U.S. adults and 17.6 % of veterans had a mental-health condition in 2024 and 2023, underscoring urgency.
Executive Order and Policy Context
President Donald Trump signed an executive order on April 18, 2026 directing the FDA and other agencies to speed psychedelic research. The order reflects support from veterans and the “Make America Healthy Again” movement led by Health Secretary Robert F. Kennedy Jr., and aligns with drug-scheduling reform.
Official Statements
FDA Commissioner Marty Makary said agency must evaluate the therapies with urgency for veterans and other patients. Compass Pathways CEO Kabir Nath said the vouchers provide momentum but will not dramatically speed the company’s approval timeline. Health Secretary Kennedy Jr. reiterated the goal of making psychedelic treatments available for psychiatric conditions within a year.
Criticism & Concerns
Democratic lawmakers warn voucher program could favor firms with White-House ties and lack pricing. Safety concerns persist for ibogaine-derived compounds, which can cause cardiac arrhythmias and hallucinations. Critics note limited data for methylone therapy compared with psilocybin. Sources differ on third drug’s name, calling it “methylone” or “methylene,” reporting inconsistency.
Conflicting Reports & Gaps
Sources differ on the name of the third drug receiving a voucher: some refer to it as “methylone,” while others call it “methylene.” The FDA has not publicly identified the companies receiving the vouchers, and detailed trial timelines remain undisclosed.
Verbatim Quotes
- “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency,” — Marty Makary, FDA Commissioner
- “Every grant proposal that I submitted to (the National Institute on Drug Abuse) was rejected,” — Deborah Mash, neurologist
- “Sounds great. Do you want FDA approval? Let’s do it.” — Joe Rogan, podcaster
- “Maybe ibogaine is just a year away from a similar position,” — Michael Thase, psychiatrist
Next Steps
The FDA expects to start the accelerated reviews within weeks and issue decisions in the next one to two months. Noribogaine’s Phase 1 trial for alcohol-use disorder is slated to begin later this year. Congressional oversight hearings on the voucher program and broader drug-scheduling reforms are planned for the summer.
