Compass Pathways’ second Phase 3 cleared: psilocybin therapy moves closer to a real FDA decision

Compass Pathways has cleared a second Phase 3 hurdle for COMP360 — its synthetic psilocybin candidate for treatment-resistant depression. Combined with the FDA’s April 24 grant of rolling new drug application review and the Trump administration’s Commissioner’s National Priority Voucher (issued the same day under the April 18 executive order on serious mental illness), Compass is now the most concrete near-term candidate for the first FDA-approved psychedelic-assisted therapy for psychiatric use.

The Phase 3 program is large by psychedelic-trial standards: more than 1,000 participants across two studies. Compass has reported that response can occur within a day of dosing and that clinically meaningful response has been sustained at six months. FDA Commissioner Marty Makary has said publicly that the agency expects to make a decision late summer or fall 2026, and that any approved therapy would have to be administered in a supervised clinical setting.

Why this matters

Three things are worth noting about how this changes the field, separate from any one drug.

A first approval moves the conversation from “psychedelics in theory” to “psychedelics with a label, a REMS, and a billing code.” That changes what providers, payers, and state regulators have to think about — quickly. It also gives the field something it has not yet had: a regulatory precedent that other developers (Usona on psilocybin, Transcend on methylone for PTSD, MindMed and Cybin on next-gen molecules) can navigate against.

A first approval does not solve access. Supervised dosing requires trained therapists, dosing rooms, REMS-compliant pharmacies, and reimbursement structures that most insurance plans have not built. The 2024 Lykos rejection of MDMA-assisted therapy for PTSD was, in retrospect, partly a referendum on how the field had structured the dosing setting and the trial blinding. Compass has tried to learn from that.

A first approval does not change indication. COMP360 is being reviewed for treatment-resistant depression, not for substance use disorder. That said, the SUD-adjacent literature on psilocybin (notably Bogenschutz’s work on alcohol use disorder, where a Phase 2 RCT showed an 83% reduction in heavy drinking days) becomes more tractable to fund, run, and translate the moment a related indication is approved.

Why this matters for people in recovery

Most people in recovery from a substance use disorder will not be a candidate for a Compass-style supervised psilocybin session in 2026, even if approval comes through this fall. Most prescribers will not be trained. Most insurance plans will not cover it. Most clinics will not yet exist.

What changes for people in recovery is the texture of the conversation. The “is psilocybin actually a treatment” question shifts from a fringe concern to a thing that primary-care providers, recovery coaches, and family members will start being asked about. The answer remains nuanced — supervised, in clinic, for specific indications, not a substitute for evidence-based SUD care — but the question is no longer hypothetical.

If you or a loved one is curious about psychedelic therapy as part of recovery, the right next step is a conversation with an addiction medicine clinician who is staying current on the literature, not a clinic ad on Instagram.

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