Compass Pathways partners with Radial Health and advances synthetic psilocybin for PTSD; FDA lifts hold on 5-MeO-DMT; DEA increases psychedelic research quotas

Synthetic psilocybin development and 5-MeO-DMT progress are advancing alongside shifting US policy for psychedelic research. Compass Pathways is partnering with Radial Health to expand clinic infrastructure across the US, and Compass also reports FDA clearance for COMP360 (synthetic psilocybin) to move into Phase 2b and Phase 3 for PTSD after receiving Investigational New Drug status. In parallel, GH Research says the FDA lifted a clinical hold on GH001, a synthetic inhalable 5-MeO-DMT product, clearing the way for Phase 3 trial planning. Policy updates include the DEA increasing 2026 manufacturing quotas for psilocybin, psilocin, and DMT for research, plus an extension of the DEA telemedicine policy through end of 2026. The issue also summarizes qualitative findings from interviews in Compass’s open label Phase 2 psilocybin trial, emphasizing themes like psychological safety, preparation and education, subjective intensity, trauma engagement, and the need for strongly informed consent.