Compass Pathways is a biotechnology company focused on evidence-based innovation in mental health. Its lead investigational program is COMP360 synthetic psilocybin, which the company positions as a potential first-in-class treatment for treatment-resistant depression. The company is headquartered in London and also has offices in New York.
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
FDA final guidance sets standards for psychedelic clinical trials. Federal agencies and states are advancing psilocybin and ibogaine research, and Eli Lilly is acquiring AtaiBeckley for $2.8 billion.
Helus completed Phase 3 enrollment for HLP003 in depression; data due Q4 2026. Compass is on track for COMP360's NDA, and an ayahuasca ingredient showed promise in a phase 2a trial.
Compass Pathways reports six-month data from its second Phase III COMP006 trial of COMP360 psilocybin for treatment-resistant depression, showing 39% of patients achieved clinically meaningful response maintained through 26 weeks. NDA submission expected in Q4 2026.
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
Compass Pathways announced positive Phase 3 data for COMP360 psilocybin therapy in treatment-resistant depression, showing statistically significant improvements in depression scores and durability through 26 weeks, with plans to file for FDA approval in Q4 2026.
COMPASS Pathways announced positive Phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant improvements across two pivotal trials with durability signals through 26 weeks and a generally well-tolerated safety profile.
Compass Pathways announced successful Phase 3 trial results for COMP360, a synthetic psilocybin treatment for treatment-resistant depression, showing rapid onset and durable effects with a 40% response rate after two doses.
Compass Pathways reported COMP360 psilocybin met the primary endpoint in its second phase III trial for treatment-resistant depression, demonstrating a statistically significant reduction in depression severity. The company plans to file a New Drug Application in Q4 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07570654 |
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder |
RECRUITING | PHASE2/PHASE3 |
| NCT06247839 |
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder |
RECRUITING | PHASE3 |
| NCT05733546 |
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05711940 |
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05624268 |
Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD |
COMPLETED | PHASE3 |
| NCT05481736 |
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study |
COMPLETED | PHASE2 |
| NCT05381974 |
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD |
WITHDRAWN | PHASE2 |
| NCT05312151 |
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder |
COMPLETED | PHASE2 |
| NCT05220410 |
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation |
COMPLETED | PHASE2 |
| NCT04739865 |
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression |
COMPLETED | PHASE2 |
