Compass Files for FDA Approval of Psilocybin, a Week Early. Three Psychedelic Drugs Are Now Under Review.
Compass Pathways said Monday it has completed its new drug application for COMP360, its synthetic psilocybin, in treatment-resistant depression. It said "two weeks" on Nov. 3 and finished in six days. The application covers two Phase 3 trials and a Phase 2b study with more than 1,000 participants combined. CEO Kabir Nath said Compass is "focused on delivering COMP360 to patients as quickly as possible, subject to FDA approval," and the company is targeting a launch in the first half of 2027.
Three at once: The FDA now has three psychedelic applications in front of it: Compass's psilocybin for treatment-resistant depression, Usona Institute's psilocybin for major depression (filed Nov. 2), and Resilient Pharmaceuticals' MDMA for PTSD, resubmitted this summer, per Psychedelic Alpha. Compass and Usona both hold National Priority Vouchers, which aim to cut review from 10–12 months to one to two. BioSpace's Heather McKenzie reports that Stifel analysts expect approval "within the 1Q27 timeframe (if not earlier)."
After approval: psilocybin is still Schedule I. The DEA has to reschedule it, and each state has its own step. We mapped which states switch on automatically in The Day After Approval. ICER's comment period on its cost review of COMP360 also closes Tuesday, Nov. 10 at 5pm ET. Both psilocybin programs are on our trials tracker, and the companies are on our intelligence hub.