COMP360

COMP360 shows sustained six-month benefit in treatment-resistant depression

Compass Pathways has announced six-month results from its second phase 3 trial of COMP360, a synthetic formulation of psilocybin being developed for treatment-resistant depression.

The 26-week data from the COMP006 study confirmed COMP360’s rapid onset and durable clinical effect, further supporting findings from the earlier COMP005 trial.

Nearly 600 participants with highly chronic treatment-resistant depression were enrolled in the study. On average, their current depressive episodes had lasted for more than three years, and participants had experienced more than six depressive episodes during their lifetime.

In the 25 mg group, 39% of participants achieved a clinically meaningful reduction in MADRS scores by week 6 after receiving two fixed doses. The treatment response was maintained through week 26.

COMP360 continued to demonstrate a generally well-tolerated and consistent safety profile. Most adverse events were temporary and occurred on the day of dosing.

A rolling New Drug Application is currently being submitted to the US Food and Drug Administration, with final submission expected in the fourth quarter of 2026. Subject to regulatory approval and rescheduling, Compass Pathways plans to launch COMP360 in the first half of 2027.

The company believes that COMP360 could represent a new approach to mental healthcare, potentially shifting treatment away from daily or frequent administration toward only a few treatment sessions per year with lasting clinical benefit.