Compass Pathways announces FDA acceptance of IND for COMP360 in PTSD and plans a January 7 webinar covering PTSD trial and TRD commercialization

Compass Pathways says the FDA has accepted its IND application for COMP360 to treat post-traumatic stress disorder (PTSD), clearing the way to start a late-stage clinical trial. The PTSD study is split into Part A and Part B. Part A uses a blinded 12-week fixed repeat-dose design comparing COMP360 25 mg vs COMP360 1 mg, with the second administration about 4 weeks after the first; the primary efficacy measure is change from baseline in CAPS-5 at Week 8. Part B is a 40-week open-label follow-up evaluating long-term safety and efficacy, with participants receiving an open-label 25 mg retreatment and COMP360 allowed as an adjunct to a single permitted oral antidepressant. Compass also ties the announcement to treatment-resistant depression (TRD) commercialization readiness. The company points to prior PTSD Phase 2 results and ongoing FDA discussion on its TRD NDA strategy, and it hosts a live January 7, 2026 webinar (10:00-11:30 am ET) with KOLs and industry leaders on PTSD trial plans and TRD commercial preparations.