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 arm reached the company-defined MADRS threshold at week 6, with benefit maintained on average to 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, with benefit maintained on average to week 26, according to the company; this does not imply uninterrupted benefit in every responder. The company reported that nearly 30% of week-6 responders subsequently reached remission following retreatment; the summary does not establish that all were retreated for partial relapse. 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% of the 25 mg arm and 6.3% of the 1 mg arm 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 results from a program still under development according to the July release: they represent corporate-sponsored findings from a substantial yet bounded cohort, and response rates—while durable—are far from universal. Nonetheless, the release documents progress in this program without establishing absolute historical priority or the legal status of every access pathway outside research.
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.
