No company will formally submit a psilocybin-based depression drug for approval to the FDA (the US drug regulator) before the end of March 2027. COMPASS Pathways, the leading company in this space, still needs to finish collecting long-term data on how well its treatment holds up over time before it can even prepare that submission. This means no psilocybin depression pill or therapy is getting officially reviewed anytime soon.
CMPS shows no imminent catalyst. Rigorous review requires durability data still maturing; COMPASS Phase 3 durability readout not yet reported. Filing readiness lags the hype.
Join our community — a free weekly Zoom circle with a master facilitator. Come sit with us first; the rest reveals itself.
Join the Free Weekly Circle →