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# Compass Pathways Reports 2nd Positive Trial for Depression Drug
- URL: https://www.fdaweb.com/compass-pathways-reports-2nd-positive-trial-for-depression-drug/
- Published: 2026-02-17T12:00:00.000Z
- Updated: 2026-09-14T13:33:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160676

Compass Pathways says its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial for treatment-resistant depression, positioning the company to seek FDA approval later this year for what could become the first FDA-approved classic psychedelic therapy.

The company says the Phase 3 COMP006 study, two 25 mg doses of its proprietary synthetic psilocybin formulation, COMP360, administered three weeks apart, produced a statistically significant and clinically meaningful reduction in depressive symptoms compared with a 1 mg control dose. At six weeks, patients receiving 25 mg achieved a mean reduction of 3.8 points on the Montgomery-Asberg Depression Rating Scale (MADRS) relative to the 1 mg group (p<0.001), meeting the trial’s primary endpoint.

The results follow positive data from the company’s first Phase 3 trial, COMP005, disclosed last year, marking two successful late-stage studies in the difficult-to-treat population, according to the company. Across both COMP005 and COMP006, the 25 mg dose showed a rapid onset of effect, with symptom improvement observed as early as the day after administration and maintained through the six-week primary endpoint. In COMP006, 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS scores of at least 25% at week six. In COMP005, 25% of patients in the 25 mg group reached that threshold at the same timepoint.

Compass says COMP360 was generally well tolerated across both Phase 3 trials, with most treatment-emergent adverse events reported on dosing days and resolving within 24 hours. The most common side effects included headache, nausea, anxiety and visual hallucinations — effects consistent with psilocybin’s pharmacologic profile. Serious adverse events were reported in 5% of patients in the 25 mg arm of COMP005 and 2% in COMP006.

The company has requested a meeting with FDA to discuss a potential rolling NDA submission, which it expects to complete in the fourth quarter.