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Psilocybin Therapy COMP360 Succeeds in Phase 3 Trials for Treatment-Resistant Depression

New 52-week data from the Phase 3 COMP005 trial demonstrates that a single 25 mg dose of COMP360 psilocybin, with optional re-dosing, provides sustained symptom relief for treatment-resistant depression. The results support a rolling FDA submission expected to conclude in late 2026.

Factlen Newsroom· Updated

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Clinical settings for psilocybin therapy are designed to provide a calming environment during the multi-hour dosing sessions.From: Single-Dose Psilocybin Therapy Shows Durable Efficacy at 52 Weeks in Phase 3 Trial for Treatment-Resistant Depression

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Key numbers

39%
Participants achieving clinically meaningful reduction in depression severity at week 6 (two doses)
25%
Participants achieving the same reduction after a single 25mg dose in the COMP005 trial
6 months
Duration the antidepressant effect was maintained for responders
3 years
Average length of the current depressive episode for enrolled patients

From: Psilocybin Therapy COMP360 Succeeds in Phase 3 Trials for Treatment-Resistant Depression

Charts, maps and images

Participants receiving the 25 mg dose maintained significant reductions in depression severity through the one-year mark.From: Single-Dose Psilocybin Therapy Shows Durable Efficacy at 52 Weeks in Phase 3 Trial for Treatment-Resistant Depression ·
Data from the Phase 3 trials suggests a second dose of COMP360 significantly enhances the clinical benefit for patients with treatment-resistant depression.From: Psilocybin Therapy COMP360 Succeeds in Phase 3 Trials for Treatment-Resistant Depression ·
While transient side effects were common on the day of dosing, severe adverse events remained rare across the Phase 3 clinical program.From: Psilocybin Therapy COMP360 Succeeds in Phase 3 Trials for Treatment-Resistant Depression ·
The 52-week data supports a rolling New Drug Application submission to the FDA.From: Single-Dose Psilocybin Therapy Shows Durable Efficacy at 52 Weeks in Phase 3 Trial for Treatment-Resistant Depression ·

Timeline

September 2026

  1. Single-Dose Psilocybin Therapy Shows Durable Efficacy at 52 Weeks in Phase 3 Trial for Treatment-Resistant Depression

August 2026

  1. Psilocybin Therapy COMP360 Succeeds in Phase 3 Trials for Treatment-Resistant Depression