The first psilocybin drug application is almost complete. Here's where COMP360 stands.

Compass Pathways expects to complete its New Drug Application for COMP360, a synthetic form of psilocybin, in the fourth quarter of 2026. If the FDA approves it, the company is aiming to launch in the first half of 2027.¹ That would make it the first psilocybin medicine approved in the United States.

The application is being filed in sections under a rolling review the FDA granted in April 2026. The same month, the agency gave COMP360 a Commissioner's National Priority Voucher, which aims to cut the final review to one or two months.² Compass said an application must still meet the FDA's usual evidence standards.² As of October 20, Compass had not announced that the final submission was in.

What the trials found

COMP360 is being tested for treatment-resistant depression, meaning depression that hasn't improved after at least two standard treatments.

• COMP005 (258 people, reported June 2025): one dose of COMP360 beat placebo by 3.6 points on the MADRS depression scale after six weeks.³
• COMP006 (581 people dosed, reported February 2026): two administrations three weeks apart beat a very low comparison dose by 3.8 points at six weeks.⁴ The gap held through week 26, and serious side effects were about as common in each arm.⁵
• Longer follow-up: in an open-label extension of COMP005 to one year, people who took another dose averaged about a 13-point drop from where they started. Without a placebo group, that number can't show how much was due to the drug.⁶

The most common side effects across the program were nausea, headache, anxiety and visual hallucinations.⁵ An earlier Phase 2 trial of the same drug reported suicidal thoughts or self-harm in every dose group, which is why monitoring rules will be part of any approval discussion.⁸

What still has to happen

1. FDA review. The FDA will weigh both Phase 3 trials. Its final guidance on psychedelic trials, issued in July 2026, sets a high bar for showing lasting benefit in chronic conditions like depression.⁷
2. Safety controls. The FDA's final guidance tells sponsors to consider whether a formal risk program (a REMS) will be needed.⁷
3. DEA rescheduling. Psilocybin is Schedule I, which means no accepted medical use. An approved product would need to be moved to a lower schedule before it could be prescribed. Compass says about 90% of U.S. patients live in states that plan to follow federal rescheduling within 30 days.¹

What it doesn't change

Approval would cover one specific, manufactured drug given under medical supervision. It wouldn't make psilocybin mushrooms legal under federal law, and it wouldn't change any state's mushroom laws. Our state-by-state map covers where state law has changed.