A New Dawn for Psychedelics: Compass Pathways Nears Major Phase 3 Psilocybin Results

Compass Pathways has completed recruitment and dosing for its pivotal phase 3 COMP005 trial of COMP360 psilocybin for treatment-resistant depression (TRD), marking the largest randomized, controlled, double-blind psilocybin treatment clinical program to date.1 3 4

The primary outcome (6-week topline data) from the COMP005 trial is expected to be released in late June 2025, positioning Compass as a potential first mover in FDA-approved psychedelic therapies for mental health disorders.1 3 5

COMP360 psilocybin has received Breakthrough Therapy designation from the US FDA and Innovative Licensing and Access Pathway (ILAP) designation in the UK, reflecting regulatory confidence in its potential to address unmet needs in TRD.1 2 3

Secondary endpoint (26-week) data from phase 3 trials is anticipated in the second half of 2026, pending completion of the COMP006 trial.1 3 5

Compass Pathways' progress and leadership in late-stage clinical trials reinforce growing momentum in the field of psychedelic medicine, with the company well-capitalized ($260.1 million cash as of March 2025) and closely watched by both the medical and investment communities.3 5