Compass Pathways’ Psilocybin Phase 3 Shows 3.8-Point MADRS Benefit
Compass Pathways’ larger COMP006 trial enrolled 581 treatment-resistant depression patients and delivered a 3.8-point mean improvement on the MADRS scale at Week 6 (p<0.001), mirroring the 3.6-point benefit observed in COMP005. Compass Pathways has requested an FDA meeting to initiate a rolling New Drug Application process in Q4 2026.
1. Phase 3 Trial Results
Compass Pathways completed two pivotal Phase 3 trials of COMP360, enrolling 581 patients in COMP006 and replicating COMP005 findings with 3.8-point and 3.6-point mean improvements on the MADRS depression scale at Week 6 (p<0.001). Across both studies, 39% of participants receiving the 25 mg dose achieved clinically meaningful reductions sustained through 26 weeks, with most treatment-emergent adverse events mild or moderate and resolving within 24 hours.
2. Regulatory Pathway
Compass Pathways has requested an FDA meeting to discuss a rolling New Drug Application submission beginning in Q4 2026, aiming to leverage these statistically significant Phase 3 results toward potential regulatory approval of COMP360 for treatment-resistant depression.