# COMP006 Trial

**Type:** Phase 3 randomized controlled trial  
**Sponsor:** Compass Pathways  
**Intervention:** COMP360 (synthetic psilocybin)  
**Indication:** Treatment-resistant depression (TRD)  
**Status:** Completed (results announced February 2026)  

## Design
- **N = 568** participants
- **Arms:** 25mg vs 10mg vs 1mg (placebo-like control)
- **Dosing:** 2 doses administered 3 weeks apart
- **Primary endpoint:** MADRS change from baseline

## Results
- **Primary endpoint met:** MADRS change -3.8 points vs control (p<0.001)
- **Response rate:** 39% vs 23% control at week 6
- **Onset:** Rapid improvement from next day post-dose
- **Second dose benefit:** 40%+ of non-remitters after first dose achieved remission after second dose
- **Durability:** Part B 26-week durability data expected early Q3 2026

## Significance
COMP006 is the second consecutive positive Phase 3 trial for COMP360, making it the first psychedelic compound to achieve two positive Phase 3 results. Combined with COMP005, this formed the basis for FDA rolling NDA review and Commissioner's National Priority Voucher (April 2026).

## Timeline
- **2026-02** — Results announced
- **2026-04-24** — FDA granted rolling NDA review based on COMP005 + COMP006 data
- **2026-Q3** — Part B 26-week durability data expected (final dataset for NDA)