Compass files psilocybin depression drug application

Compass Pathways said it has completed a New Drug Application submission to the U.S. Food and Drug Administration for COMP360 psilocybin, its investigational synthetic psilocybin treatment for treatment-resistant depression.

The biotechnology company said the application was supported by data from two Phase 3 trials and a Phase 2b study that each met its primary endpoint and involved more than 1,000 participants living with chronic treatment-resistant depression.

Chief executive Kabir Nath said the submission marked the completion of “the largest late-stage clinical program in psychedelic treatments” and that the company would continue the FDA review process.

Compass said it expects a possible launch in the first half of 2027, subject to FDA approval. It also said commercialisation in the United States would require steps including rescheduling by the U.S. Drug Enforcement Administration and states if the treatment is approved.

The company said treatment-resistant depression is defined by an inadequate response to two or more courses of antidepressants at adequate dose and duration. It cited estimates that about 4 million people in the United States live with the condition.