Compass Pathways expects to finish its psilocybin drug application this quarter

Compass Pathways expects to complete its rolling New Drug Application (NDA) for COMP360, a synthetic psilocybin for treatment-resistant depression, before the end of 2026. STAT reported on October 14, 2026 that the company is preparing to finish the submission "this quarter" and aims to launch early next year. Speaking at the STAT Summit, CEO Kabir Nath said Compass will "go slow before we go fast."

Where the application stands

On April 24, 2026, the FDA granted Compass's request for a rolling NDA submission and review. The same day, the FDA awarded three Commissioner's National Priority Vouchers to psychedelic drug developers: Compass for COMP360 in treatment-resistant depression, Usona Institute for its psilocybin in major depressive disorder, and Transcend Therapeutics for methylone in PTSD.

Compass says the voucher can bring the FDA's review down to about one to two months after the NDA is filed, without changing the evidence standards the drug has to meet. In its August 5, 2026 quarterly report, Compass said some NDA modules had already been submitted and it expected to file the rest in the fourth quarter of 2026. No FDA decision date has been announced.

What the Phase 3 trials showed

Both Phase 3 results below are company-reported topline data. As of October 2026, we found no peer-reviewed journal paper for either trial's main results.

• COMP005 gave 258 participants at 32 U.S. sites a single 25 mg dose or a placebo. At week 6, scores on the MADRS depression scale had dropped 3.6 points more in the psilocybin group than in the placebo group (p<0.001), Compass reported on June 23, 2025. In 26-week data released later, 25% of the 25 mg group had a clinically meaningful improvement at week 6 that lasted at least through week 26.
• COMP006 gave 581 participants two doses three weeks apart, at 25 mg, 10 mg or 1 mg. At week 6, the 25 mg group improved 3.8 points more than the 1 mg group (p<0.001), Compass reported on February 17, 2026.

On September 9, 2026, Compass released 52-week data from COMP005's open-label extension, which about 70% of participants entered. People first given 25 mg who received another dose averaged a 13-point drop from their starting MADRS score at week 52. People first given placebo who then received a 25 mg dose improved by about 10 points. In the six weeks after the extension dose, 40% to 45% responded and about 30% reached remission. Compass reported no new safety signals. Because the extension was open-label, participants knew they were receiving psilocybin.

What approval would and wouldn't mean

Compass is guiding to a U.S. commercial launch in the first half of 2027, "subject to FDA approval and DEA rescheduling." Psilocybin is a Schedule I drug, so after an FDA approval the DEA would still need to reschedule the product, and then the states would follow. Compass said in August that about 90% of the U.S. patient population lives in states that intend to reschedule within 30 days of federal action.

If approved, COMP360 would be a prescription drug given under supervision in a clinic. Nath expects it to carry a REMS, a formal FDA safety program. Compass plans to deliver it through roughly 8,500 interventional psychiatry clinics that grew up around J&J's Spravato, BioPharma Dive reported, with each treatment involving six to eight hours of observation. Compass expects treatment to be given "one- to four-time per year" and positions COMP360 as an addition to Spravato, not a replacement.

Approval would not make magic mushrooms legal. It would cover one synthetic psilocybin product given in clinics. Psilocybin mushrooms would remain a Schedule I drug under federal law, and state rules for them would not change. See our state-by-state law tracker for current rules.

What happens next

The next milestone is the completed NDA, which Compass has guided to the fourth quarter of 2026. Nath told STAT that Compass is talking with commercial insurers and CMS about coverage, and he named Spravato as a pricing reference point without committing to a price. He also said early missteps could damage the field, which is the context for his "go slow before we go fast" line.

Until a drug is approved, the main options for supervised psilocybin are clinical trials and the state-licensed programs in Oregon and Colorado. Our guide to psilocybin therapy near you covers both, and our psilocybin research page tracks trial results as they come out.