COMP360: Synthetic Psilocybin in Clinical Research

COMP360 is a proprietary, investigational formulation of synthetic psilocybin developed by Compass Pathways. The compound is being studied as a potential treatment for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 has received FDA Breakthrough Therapy designation for TRD and remains an investigational product rather than an approved medicine.

What Is COMP360?

COMP360 is designed as a standardized pharmaceutical formulation of psilocybin for use in controlled clinical research. Research involving COMP360 examines how psychedelic-assisted treatment may affect symptoms of difficult-to-treat mental health conditions.

Compass Pathways has conducted extensive clinical research into COMP360, including large Phase 3 studies investigating its potential role in treatment-resistant depression.

COMP360 and Treatment-Resistant Depression

Clinical development of COMP360 has focused heavily on people with treatment-resistant depression, a condition in which depression symptoms have not adequately responded to previous treatments.

In 2026, Compass reported that its second Phase 3 TRD study, COMP006, achieved its primary endpoint. The company reported a statistically significant difference between the 25 mg and 1 mg groups at Week 6. These are company-reported clinical-trial findings and do not mean that COMP360 is currently an approved treatment.

The FDA granted Compass a request for rolling NDA submission and review in April 2026 based on Phase 3 data.

COMP360 and PTSD Research

COMP360 is also being investigated for post-traumatic stress disorder. An earlier Phase 2 study evaluated a single 25 mg dose in 22 participants and reported improvements in PTSD symptom measures over the 12-week follow-up period. Because the study was open-label and relatively small, its findings require confirmation through larger controlled studies.

Compass has subsequently advanced COMP360 into late-stage PTSD research.