Washington Just Fast-Tracked Psychedelics. Nobody’s Fast-Tracking the Safety Answers.

Compass Pathways’ synthetic psilocybin candidate, COMP360, posted a 3.6-point reduction on the standard depression scale at six weeks in its COMP005 Phase III trial — meaningful, if modest next to the 12-point reduction the same drug showed in earlier Phase II data. A second pivotal trial, COMP006, has full Part A results expected in early 2026. Chief Patient Officer Steve Levine called the moment a turning point: “We are so excited about the potential for both TRD and PTSD now to potentially have new options for patients. This really can change and hopefully save the lives of lots of people.” Analyst projections point to a filing for FDA approval as soon as Q3 2026, with potential approval in 2027 — which would make COMP360 the first classic psychedelic ever approved for a mental-health indication in the United States.

The federal government decided to help that timeline along, and in doing so, it may have tipped its hand about which psychedelic it’s actually most eager to move.

An April 18 executive order directs the FDA to prioritize psychedelic compound review and issue Commissioner’s National Priority Vouchers — a tool that can compress review timelines to a matter of months — to any psychedelic holding Breakthrough Therapy designation. It orders the DEA to loosen research restrictions, tells HHS, FDA, and the VA to share data faster, and puts $50 million behind states willing to match federal psychedelic research investment. If a trial clears Phase 3, the Attorney General is now directed to immediately review the compound for rescheduling.

Buried in that order is a detail Harvard Law’s I. Glenn Cohen flagged as genuinely strange: ibogaine gets named twice — once in the purpose section, once in the “right to try” provision — ahead of psilocybin and MDMA, both of which have far more mature trial data behind them. Fellow scholar Mason Marks called the choice “unexpected because… ibogaine is one that has arguably not ‘met basic safety requirements.’” Ibogaine carries known cardiac risks serious enough that several countries restrict its clinical use; naming it first in a “right to try” pathway, ahead of compounds with actual Phase 3 data, is the kind of detail that tells you an executive order was written with someone specific in mind.

None of this resolves the question that matters most for anyone watching psychedelics as a potential tool against addiction and its common companions — depression, PTSD, treatment-resistant despair. Cohen’s read is that the priority vouchers could shave review time to one or two months, but only if the FDA’s own approval criteria don’t quietly do the same gatekeeping work at a different stage. And the delivery model is still wide open: whether psilocybin therapy ends up looking like a tightly controlled ketamine clinic or something closer to a GP writing a prescription will determine who can actually afford or access it once it’s legal — a gap that, unaddressed, tends to fall hardest on exactly the people this population of patients already includes.