In brief
- On July 7, Compass Pathways presented 26-week data from COMP006, its second phase 3 clinical trial evaluating synthetic psilocybin (COMP360) for treatment-resistant depression.
- Among 581 participants, 39% in the 25 mg cohort sustained a clinically meaningful improvement from week 6 through week 26.
- The company expects to finalize its new drug application with the FDA in the fourth quarter of 2026.
British pharmaceutical company Compass Pathways has announced six-month results from COMP006, the second of its two pivotal phase 3 clinical trials evaluating COMP360, a standardized synthetic psilocybin formulation. The data, released on July 7, demonstrate that the antidepressant effect observed following initial dosing is sustained over time—addressing one of the central questions that had surrounded this therapeutic approach.
A phase 3 program concluded with two positive trials
COMP006 enrolled 581 participants living with treatment-resistant depression—individuals who had failed to respond to at least two conventional antidepressants. The study design evaluated two doses of COMP360 (25 mg with 296 participants, and 10 mg with 142 participants) against a 1 mg reference dose (143 participants), administered across two sessions spaced three weeks apart and coupled with psychological support. This trial follows COMP005, the initial phase 3 study, which compared a single 25 mg dose to placebo in 258 participants and met its primary endpoint at six weeks.
What the numbers show
In the 25 mg arm of COMP006, 39% of participants achieved at least a 25% reduction on the MADRS scale (the standard clinical tool for assessing depression severity) at week 6, and this level of therapeutic response was sustained through week 26. Among participants who received an additional retreatment cycle following a partial relapse, approximately 30% of responders achieved clinical symptom remission. Regarding safety, the most common adverse events were nausea, headache, anxiety, and transient visual disturbances, mostly concentrated on the day of administration; serious adverse events occurred in 5.7% to 6.3% of participants across the 26-week follow-up period.
What this means
Compass Pathways has already initiated a rolling submission for regulatory approval with the US Food and Drug Administration (FDA) and expects to complete it in the fourth quarter of 2026, targeting a commercial launch in the first half of 2027 should the regulatory review proceed as anticipated. These findings should be interpreted with the standard caution warranted for compounds that have not yet been evaluated by regulatory agencies: they represent corporate-sponsored findings from a substantial yet bounded cohort, and response rates—while durable—are far from universal. Nonetheless, this marks the first time a psilocybin-based candidate has advanced this close to securing a formal pharmaceutical indication, potentially opening a regulated access pathway that currently does not exist outside of clinical research settings.
Source
- Compass Pathways. Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile. Compass Pathways Investor Relations, July 7, 2026.
Educational content written from a harm reduction perspective and with respect for individual freedom. It is not a substitute for advice from a healthcare professional and is not intended to encourage or condemn any drug use.
