Preliminary Phase 2 Data Shows Psilocybin for PTSD Is Well-Tolerated


Initial data from phase 2 safety profile for psilocybin in the treatment of PTSD indicates the treatment is well-tolerated.




Preliminary data from a phase 2 clinical trial of COMP360 psilocybin for the treatment of patients with posttraumatic stress disorder (PTSD) found the treatment was well tolerated, according to a press release.1

The phase 2 trial was an open label study of 22 patients with PTSD; the PTSD was a result of trauma experienced as an adult. Patients were monitored for 12 weeks after receiving a single 25 mg dose of the agent. The international study is being conducted in the United States and the United Kingdom, with study cites at The Institute of Psychiatry, Psychology and Neuroscience at King’s College in London, Icahn School of Medicine at Mount Sinai in New York City, and Sunstone Therapies in Rockville, Maryland.

The preliminary data included results of evaluating patients at 24 hours following the 25 mg dose administration. There were no treatment-emergent serious adverse effects, and the investigators noted psilocybin “was well-tolerated and the safety profile was as expected.” Full data is expected to be available in spring 2024.1

“Safety is of paramount importance when developing potential new treatments, so we are pleased to see these positive safety signals,” Guy Goodwin, FMedSci, DPhil, chief medical officer of Compass Pathways, said in a press statement. “These results are consistent with findings from other studies and add to the growing body of evidence to demonstrate the potential of COMP360 in difficult-to-treat mental health conditions.”1

“PTSD is a very distressing condition and existing treatments are not always effective. It’s encouraging to see these initial safety results for COMP360 psilocybin treatment in this patient population and we look forward to a more detailed analysis of the study next year,” added James Rucker, MD, PhD, consultant psychiatrist and lead of the Psychoactive Trials Group at King’s College in London.1

COMP360 is a synthetic psilocybin and is administered in conjunction with psychotherapeutic support. In addition to research on its use for PTSD, it is currently being investigated for the treatment of other psychiatric disorders. Studies are underway for anorexia nervosa. The agent has been designated as a breakthrough therapy for treatment-resistant depression (TRD), and a phase 3 randomized, controlled, double-blind psilocybin treatment clinical program for TRD currently underway is the largest of its kind conducted to date.

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1. Compass Pathways announces investigational COMP360 psilocybin treatment was well-tolerated in phase 2 study of post-traumatic stress disorder. Press release. December 19, 2023. Accessed December 20, 2023.

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