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.
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.
Compass Pathways reported positive phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant symptom reduction. The company plans to discuss FDA filing with a New Drug Application expected in Q4 2026.
Compass Pathways announced positive results from its second Phase 3 trial of synthetic psilocybin COMP360 for treatment-resistant depression, showing a 3.8-point reduction in depression scores. The company plans to meet with the FDA to discuss a rolling approval application.
Compass Pathways reports positive Phase 3 results for synthetic psilocybin in treatment-resistant depression, while a Phase 2 trial demonstrates rapid antidepressant effects from single-dose DMT. Both studies show modest efficacy signals amid growing pharmaceutical interest in psychedelic compounds.
Compass Pathways' COMP360 synthetic psilocybin met primary endpoints in Phase 3 trials for treatment-resistant depression, with the company planning to submit a new drug application in Q4 2026.
| 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 |
NOT_YET_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 |
ACTIVE_NOT_RECRUITING | 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 |
