FDA Fast-Track Sets Stage for Possible First Psychedelic Approvals by Fall
The first psychedelic-based treatments for depression and posttraumatic stress disorder could be approved as early as this fall, as a new FDA pathway accelerates review for drugs already backed by late-stage clinical data.
Following a White House executive order seeking to speed development of psychedelics for psychiatric disorders, the FDA awarded three compounds National Priority Vouchers and the US Drug Enforcement Administration was directed to conduct a quick review of psychedelics that have completed phase 3 research, in anticipation that they could be moved from Schedule 1 to Schedule 2 or 3 upon FDA approval.
The order also led to the awarding of an investigational new drug application for DemeRx’s DMX-1001, a form of ibogaine, for alcohol use disorder. Of the three compounds given priority vouchers, Compass Pathways’ COMP360 — a synthetic psilocybin for treatment-resistant depression — is furthest along.
The nonprofit Usona Institute’s psilocybin for major depressive disorder and Transcend Therapeutics’ TSND-201 (methylone, a synthetic drug similar to MDMA) for PTSD are also on a fast track.
FDA Commissioner Marty Makary, MD, said in an interview he expected the agency to issue a decision by late summer or fall and that the therapies would be given in a “supervised clinical setting.” Psychiatrists say the promise of these therapies is tempered by questions about how they will be administered, cost, reimbursement, long-term safety, and durability of effect.
“There’s no way the FDA is going to allow this to be taken home without supervision,” said Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto. He said the FDA will probably require one or two health care professionals to be on site during administration and would institute a Risk Evaluation and Management Strategy for the compounds.
“There are legitimate safety concerns and there are very profound non-ordinary effects that people have when they take psychedelics,” he said, noting that the “trips” can “be quite unpleasant and quite distressing.” Charles Nemeroff, MD, PhD, the Matthew P.
Nemeroff Endowed Chair in the Department of Psychiatry & Behavioral Sciences at the University of Texas at Austin Dell Medical School, agreed that administration “must be under medical supervision.” A member of the American Psychiatric Association’s research council and co-director of the Charmaine & Gordon McGill Center for Psychedelic Research & Therapy at Dell Medical School, he said trial participants have experienced intense, raw emotions that can lead to hypertension and other cardiac effects.
Efforts to speed psychedelics into use are “really exciting,” he said, adding it’s possible they are “an absolute game changer for psychiatry,” but cautioned the drugs “are not panaceas.” Paraphrasing Timothy Leary, he said their utility is dictated by “set and setting,” and it remains unclear which patients will most benefit and under what circumstances.
The FDA has already been reviewing data from Compass, Usona, and Transcend as part of the typical approval process, which can take years, sometimes up to a decade. Seeking to telescope reviews, the agency began the Commissioner’s National Priority Voucher program in June 2025, cutting review time to 1–2 months for therapies considered breakthroughs or those that address unmet medical needs or urgent emerging threats.
If approvals come as anticipated, regulators and clinicians will still need to define treatment frameworks, supervision requirements, and safety monitoring. Scheduling decisions by the DEA would follow FDA approvals, and early real-world use is expected to inform who benefits most and how best to deliver these therapies.