RFK Jr. Put Psychedelics on a Federal Fast Lane. Here's Who Stands to Benefit.

On April 18, the Trump administration issued an executive order directing federal agencies to accelerate the research and regulatory review of Schedule I psychedelics — specifically psilocybin, MDMA, LSD, and ibogaine — for therapeutic use. A week later, the FDA awarded National Priority Vouchers to three companies: Compass Pathways, whose synthetic psilocybin COMP360 is being developed for treatment-resistant depression; the nonprofit Usona Institute, developing psilocybin for major depressive disorder; and Transcend Therapeutics, developing TSND-201 (a synthetic compound similar to MDMA) for PTSD. The executive order also committed $50 million in HHS funds to psychedelic research.

The fastest and furthest along is Compass. The company is targeting a rolling NDA submission in Q4 2026, and FDA Commissioner Makary has indicated a decision could come by late summer or fall 2026 — which would mean a ruling before the end of this year. The evidence base behind COMP360 for treatment-resistant depression is the most developed of the three: Compass has completed a Phase 2b trial (COMP360’s effect on TRD was published in The Lancet in 2022, showing significant antidepressant effects at 25mg dose) and is currently in Phase 3.

The contrast with Lykos Therapeutics — the company that was seeking approval for MDMA-assisted therapy for PTSD and was rejected by the FDA in 2024, with an additional trial required — is instructive. Lykos’s data had serious design problems: a high expectation-unblinding rate, concerns about therapist misconduct in some trial sites, and a primary outcome that didn’t cleanly replicate. The rejection was not a statement about whether MDMA-assisted therapy can work; it was a statement about whether that specific evidence package was sufficient. Other companies are now building their programs with those failure modes explicitly in mind.

The clinical case for psychedelic-assisted therapies in substance use disorder — particularly alcohol use disorder and opioid use disorder — is separate from the treatment-resistant depression case and is moving more slowly. Ibogaine, which the executive order explicitly includes, has been used for decades in unregulated settings for opioid detoxification; preliminary evidence from a January 2024 Nature Medicine paper on ibogaine in veterans with TBI-associated psychiatric conditions got significant attention. But ibogaine carries serious cardiac risks, and the regulatory path for it is genuinely more complicated than the psilocybin pathway.

For the psychedelics and empathogens category, the next several months are among the most consequential in the field’s history. A Compass approval would be the first FDA-approved psychedelic-assisted therapy, establishing a regulatory template. The companies watching most closely are not the ones that got the vouchers — they’re the ones deciding, right now, whether the path is clear enough to enter. The fast lane is now officially open. What matters is where it leads, and whether the evidence meets the standard when it gets there.

---

This post is part of ongoing coverage of psychedelic-assisted therapies and FDA science and medicine developments.