Psilocybin Therapy Clears Major Hurdle as Second Phase Three Trial Succeeds

Psilocybin Therapy Takes a Giant Leap Forward

Compass Pathways has announced a landmark result in the race to bring psychedelic-assisted therapy into mainstream medicine. The company's synthetic psilocybin treatment, COMP360, has successfully met the primary endpoint in its second pivotal Phase three clinical trial for treatment-resistant depression, marking a historic moment for the field of psychiatry.

Consistent Results Across Over One Thousand Patients

The COMP006 trial enrolled five hundred and eighty-one participants across North America and Europe, testing two fixed doses of twenty-five milligrams of COMP360 administered three weeks apart against a one milligram control dose. At week six, patients receiving the higher dose showed a mean improvement of three point eight points on the Montgomery-Asberg Depression Rating Scale compared to the control group, with a p-value of less than zero point zero zero one.

These results closely mirror the company's first Phase three trial, COMP005, which met its primary endpoint in June twenty twenty-five with a mean treatment difference of three point six points. Together, the two trials have involved more than one thousand participants and delivered remarkably consistent outcomes.

Long-Term Benefits From Just One or Two Doses

Perhaps the most striking finding comes from twenty-six-week durability data from the first trial. Twenty-five percent of participants who received the twenty-five milligram dose maintained clinically meaningful improvement through six months after receiving just one or two doses. Additionally, over forty percent of patients who initially improved but had not achieved full remission by six weeks went into remission after a second dose.

Path to FDA Approval

Compass has requested a meeting with the FDA to discuss a rolling submission for its New Drug Application, with full submission expected in the fourth quarter of twenty twenty-six. COMP360 holds FDA Breakthrough Therapy designation, which provides expedited review pathways. If approved, it would be the first psilocybin-based treatment authorised by the FDA and would represent a fundamental shift from daily antidepressant regimens to an episodic treatment model.

Safety Profile

Safety data from both trials showed that most adverse events, including headache, nausea, anxiety, and visual hallucinations, occurred on dosing days and resolved within twenty-four hours. The rate of serious adverse events related to suicidal ideation was less than one percent across both studies, with no clinically meaningful difference between treatment and control groups.