COMP360 for Treatment-Resistant Depression: Insights on New Phase 3 Trials From Guy Goodwin, MD

Compass Pathways recently announced the successful achievement of the primary endpoint in the ongoing phase 3 COMP006 trial evaluating 2 fixed doses of COMP360—a synthetic, proprietary formulation of psilocybin for managing treatment-resistant depression (TRD).^1,2 Guy Goodwin, MD, the chief medical officer at Compass Pathways, shared his thoughts on this recent news.

COMP006 is the second of 2 phase 3 trials evaluating COMP360. Across both COMP005 and COMP006 to date, COMP360 has generally demonstrated a well-tolerated and safe profile, with all treatment-emergent adverse events being mild or moderate in severity, and most resolving within 24 hours. The data confirms a statistically significant rapid onset from the day following administration and maintained at all measured timepoints through week 6 in both clinical trials in the 25 mg arm. Data from the first trial, COMP005, suggest that participants who saw a clinically meaningful reduction in MADRS maintained durable treatment effect through at least week 26, after just 1 or 2 doses. Also worth noting, retreatment with a second dose was well-tolerated by participants with a consistent safety profile.

“The announcement of the results from our second phase 3 clinical trials is a landmark. It means that it is the third time that we have been able to demonstrate a clinically and statistically significant effect of COMP360 psilocybin in treatment-resistant depression. And that means, essentially, that we are in a position to get ready to submit an application to the the FDA, and therefore, we hope we are on the way to some kind of approval later in the year. That's the plan,” shared Goodwin.

What results from this phase 3 trial surprised Goodwin? The consistency of the effect of the first administration and the durability.

“No one had studied, under double-blind conditions, any antidepressant up to 26 weeks. We did that in the first of the studies that we have completed,” shared Goodwin.

Dr Goodwin is the chief medical officer at Compass Pathways, as well as an emeritus professor of psychiatry and a National Institute for Health Research emeritus senior investigator at the University of Oxford, UK.

References

1. Compass Pathways successfully achieves primary endpoint in second phase 3 trial evaluating COMP360 psilocybin for treatment-resistant depression. News release. February 17, 2026. Accessed February 17, 2026. https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx

2. Kuntz L. COMP360 psilocybin for treatment-resistant depression achieves primary endpoint in phase 3 trial. Psychiatric Times. February 17, 2026. https://www.psychiatrictimes.com/view/comp360-psilocybin-for-treatment-resistant-depression-achieves-primary-endpoint-in-phase-3-trial