# Compass Pathways

**Type:** Clinical-stage biopharmaceutical company  
**Focus:** Mental health, psychedelic therapeutics  
**Headquarters:** United Kingdom  
**Lead Asset:** COMP360 (synthetic psilocybin)  

## Overview

Compass Pathways is a clinical-stage biopharmaceutical company developing COMP360, a proprietary synthetic psilocybin formulation for treatment-resistant depression and other mental health conditions. The company holds FDA Breakthrough Therapy Designation and reported the first positive Phase 3 efficacy data for any investigational psychedelic in June 2025.

## Key Programs

### COMP360 Psilocybin
- **Indication:** Treatment-resistant depression (TRD)
- **Mechanism:** 5-HT2A receptor agonism with embedded psychological support protocol
- **Status:** Phase 3 (COMP005 positive, COMP006 pending)
- **Regulatory:** FDA Breakthrough Therapy Designation, Commissioner National Priority Voucher (April 2026)

## Clinical Evidence

### COMP005 Phase 3 Trial
- **Design:** Randomized, double-blind, placebo-controlled (n=258, 32 US sites)
- **Population:** Treatment-resistant depression (≥2 failed antidepressant courses)
- **Intervention:** Single dose COMP360 25mg vs. placebo with psychological support protocol
- **Primary Endpoint:** MADRS change at Week 6: -3.6 points (95% CI [-5.7, -1.5], p<0.001)
- **Durability:** Benefits maintained through 26-week follow-up from single dose
- **Safety:** All adverse events mild-to-moderate, resolved within 24 hours

## Regulatory Pathway

- **NDA Filing:** Expected Q4 2026 (pending COMP006 26-week data)
- **Breakthrough Designation:** Held for multiple years
- **Priority Voucher:** Received April 24, 2026

## Significance

COMP005 represents the first Phase 3 evidence for a psychedelic drug and the first classic psychedelic to reach Phase 3 efficacy threshold, establishing proof-of-concept for FDA approval of the broader class.

## Timeline

- **2025-06-23** — COMP005 Phase 3 trial achieves primary endpoint with MADRS -3.6 point improvement (p<0.001), marking first positive Phase 3 data for any investigational psychedelic
- **2026-04-24** — Receives Commissioner National Priority Voucher
- **2026-Q4** — NDA filing expected (pending COMP006 data)