NDA Submission Complete: COMP360 Psilocybin for Treatment-Resistant Depression

Compass Pathways today announced they have completed their submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for COMP360 psilocybin—their investigational synthetic, proprietary formulation of psilocybin for treatment-resistant depression (TRD).¹

If approved, COMP360 would become the first classic psychedelic medicine ever approved by the FDA.

"People living with treatment-resistant depression have gone too long experiencing disproportionate suffering, despite years of trying available treatment options without meaningful relief. The completion of our NDA submission reflects years of perseverance and commitment by patients, families, advocates, researchers and healthcare providers who have worked alongside us toward the shared goal of bringing new treatment options to this community,” said Kabir Nath, the chief executive officer of Compass Pathways. “Compass is leading the development of this new class of medicines with rigor and discipline, successfully completing the largest late-stage clinical program in psychedelic treatments. We are deeply grateful to the entire Compass team for the achievement of this extraordinary milestone. We look forward to continuing the review process, and we are focused on delivering COMP360 to patients as quickly as possible, subject to FDA approval. We have a world-class and fully scaled commercial organization, and the infrastructure and capabilities in place to support broad patient access upon approval.”

Data Supporting COMP360

The NDA submission is supported by data from Compass’ 2 positive phase 3 clinical trials, COMP005 and COMP006, which involved more than 1000 participants, and reinforce COMP360’s unique and highly differentiated profile of rapid onset and durability of effect.

The COMP360 phase 3 program targeted participants who represented a highly chronic TRD population. In COMP006, participants had current depressive episodes lasting on average longer than 3 years and an average of more than 6 lifetime depressive episodes. In this severe population, investigators found that 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) by week 6, following 2 fixed doses of COMP360, and maintained durable response at least through week 26. This compares favorably to the 25% in the first study, COMP005, following just a single dose. Ultimately, these findings support the value of a second dose in enhancing clinical benefit for some patients.^2,3

Gus Alva, MD, a Psychiatric Times board member and an investigator in the COMP005 and COMP006 phase 3, emphasized that the transformational clinical responses he witnessed required anchoring with psychotherapy and trained therapist supervision.

Next Steps

COMP360 has the potential for accelerated approval, as the FDA awarded it a National Priority Voucher (NPV), which sets a 1- to 2-month review target. If approved, Compass is on track for an expected launch in the first half of 2027.

References

1. Compass Pathways completes COMP360 psilocybin New Drug Application to U.S. FDA for treatment-resistant depression. News release. November 9, 2026. Accessed November 9, 2026. https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Completes-COMP360-Psilocybin-New-Drug-Application-to-U-S--FDA-for-Treatment-Resistant-Depression/default.aspx

2. Compass Pathways announces six-month data from second phase 3 trial confirming rapid and durable profile. July 7, 2026. Accessed November 9, 2026. https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Announces-Six-Month-Data-from-Second-Phase-3-Trial-Confirming-Rapid-and-Durable-Profile/default.aspx

3. New 6-month data from second phase 3 trial confirms rapid effect of COMP360 for TRD. Psychiatric Times. July 7, 2026. https://www.psychiatrictimes.com/view/new-6-month-data-from-second-phase-3-trial-confirms-rapid-effect-of-comp360-for-trd