COMPASS Pathways files NDA for COMP360 psilocybin in treatment-resistant depression

What's the deal? On 9 November 2026, COMPASS Pathways completed its submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for COMP360, its proprietary synthetic formulation of psilocybin, for treatment-resistant depression (TRD) — depression that has not responded adequately to earlier treatments.

Why it matters: The filing is backed by two Phase 3 trials and a Phase 2b study, each of which met its primary endpoint and involved more than 1,000 participants with highly chronic TRD. COMP360 holds FDA Breakthrough Therapy designation and Innovative Licensing and Access Pathway (ILAP) status in the UK, both of which can speed regulatory review. An estimated 4 million people in the US live with TRD, yet fewer than 5% are currently on a treatment indicated for it.

COMPASS runs the largest late-stage clinical programme in classic psychedelics: a pivotal study of COMP360 in post-traumatic stress disorder (PTSD) is also under way. The company says launch readiness is on track for an expected launch in the first half of 2027, subject to FDA approval; the drug would also need to be rescheduled by the US Drug Enforcement Administration before it can be commercialised.

Read more: COMPASS Pathways, 09 November 2026