Study summary
Psilocybin worked in two phase 3 trials for hard-to-treat depression
What was tested
COMP360, a pharmaceutical form of psilocybin given in supervised sessions, in people whose depression had not responded to at least two antidepressants.
What they found
- Both trials met their main goal. In the second, two 25 mg doses three weeks apart reduced symptoms more than a 1 mg dose at week 6.
- Follow-up showed the response lasting at least 26 weeks.
- The company is submitting its FDA application in stages, with the final part expected in late 2026.
- It has said it hopes to launch in the first half of 2027, if approved and if the drug is rescheduled.
What it means
Likely to be the first psychedelic to reach an FDA decision for depression.
Last reviewed 2026-11-14 by the Find a Trial editorial team.
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