COMP360 is the company Compass Pathways’ own formulation of psilocybin, given with psychological support. Its largest published phase 2 trial, with 233 adults with treatment-resistant depression, found a larger week-3 drop at the highest dose than at a very low control dose; sustained response at 12 weeks did not clearly support it, and adverse events occurred in 77% (Goodwin et al., 2022).
Two phase 3 trials followed. The company’s August 2026 quarterly report says COMP005 met its primary endpoint with a 3.6-point MADRS difference and COMP006 with a 3.8-point difference (Form 10-Q, 5 August 2026). The same filing says the FDA granted a rolling review of its New Drug Application, which was ongoing (Form 10-Q, 5 August 2026). COMP006 listed 8 Canadian sites in the registry (ClinicalTrials.gov NCT05711940).
These phase 3 figures are the sponsor’s own reports, and this site found no peer-reviewed publication of them for its explainer. A registry site in Canada is not Health Canada approval: psilocybin has no approved product in Canada (Health Canada). This is a regulatory description, not investment or medical advice.
Sources
- Goodwin et al., NEJM, 2022
- COMPASS Pathways Form 10-Q, 5 August 2026
- ClinicalTrials.gov NCT05711940 (COMP006)
- Health Canada: Psilocybin and psilocin
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