Compass Pathways announced on Monday that it completed a New Drug Application for its synthetic psilocybin product, COMP360, targeting treatment-resistant depression (TRD). The filing follows two Phase 3 trials and a Phase 2b study that all met primary endpoints.
The company, a London-based drugmaker that grew out of a nonprofit research effort and went public on Nasdaq in September 2020, said Monday that it had completed its submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for COMP360.
Submission details and regulatory status
The company said the NDA leverages data from trials named COMP005 and COMP006, plus a Phase 2b investigation.
Both Phase 3 studies enrolled more than 1,000 participants with chronic TRD, a condition defined by failure of at least two antidepressant courses.
COMP360 earned Breakthrough Therapy designation from the FDA, and a national priority voucher was granted in April.
The voucher could shrink review time to one or two months after the final application, rather than the typical ten-to-twelve-month window.
The voucher program aims to shorten review to one or two months after the final application is submitted, compared with the usual 10 to 12 months, while preserving FDA safety and efficacy standards.
Clinical outcomes supporting the application
In COMP005, a single 25 mg dose of COMP360 lowered the Montgomery-Åsberg Depression Rating Scale by 3.6 points versus placebo at week six (p < 0.001).
The improvement appeared the day after dosing and persisted through 26 weeks.
COMP006 administered two 25 mg doses three weeks apart and achieved a 3.8-point advantage over a 1 mg active control at the same endpoint (p < 0.001).
Open-label follow-up from COMP005 reported continued benefit through week 52 for participants receiving an additional dose.
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Compass estimates roughly four million Americans live with TRD, yet fewer than five percent receive a therapy specifically indicated for the condition.
Compass estimates that roughly 4 million people in the United States live with TRD, of whom fewer than 5% receive a therapy specifically indicated for the condition, highlighting a large unmet clinical need.
The firm also runs a late-stage trial of the drug in post-traumatic stress disorder.
Industry context of psychedelic drug development
Other firms are advancing classic psychedelics toward late-stage approval. Definium Therapeutics, formerly MindMed, posted three positive Phase 3 readouts for its LSD tablet DT120 and plans a generalized anxiety disorder filing in early 2027.
Helus Pharma, previously Cybin, expects topline data this quarter from its Phase 3 APPROACH trial of HLP003, a deuterated psilocin analog, and targets an NDA in 2028.
AtaiBeckley, now owned by Eli Lilly after a deal valued up to $3.8 billion, began Phase 3 work on an intranasal BPL-003 candidate in the second quarter of 2026.
GH Research has selected doses for a global Phase 3 program of its inhaled GH001.
Regulatory timeline and market outlook
Compass expects a potential U.S. launch of COMP360 in the first half of 2027, contingent on FDA approval and DEA rescheduling of psilocybin, which remains a Schedule I substance.
State-level scheduling rules may further shape rollout locations.
CEO Kabir Nath said, “People living with treatment-resistant depression have gone too long experiencing disproportionate suffering.” He described the program as the largest late-stage clinical effort for a psychedelic treatment.
If approved, the product could become the first classic psychedelic cleared by the FDA. As of November 9, the agency had not publicly confirmed formal acceptance of the application for review.
