6d4ad3213d
- Source: inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md - Domain: health - Claims: 0, Entities: 1 - Enrichments: 2 - Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5) Pentagon-Agent: Vida <PIPELINE>
28 lines
No EOL
1.3 KiB
Markdown
28 lines
No EOL
1.3 KiB
Markdown
# 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) |