FDA Green Lights Clinical Trial of Low-Dose Psilocybin

The FDA has cleared Diamond Therapeutics’ investigational new drug application for a clinical trial evaluating the effects of repeat low doses of psilocybin in patients with demoralization.

The trial, to enroll 60 participants, will evaluate the feasibility, efficacy and mechanisms of action of low doses of psilocybin in this indication. The study will be led by Peter Hendricks, a clinical psychologist and professor at University of Alabama at Birmingham.

The study builds on the results of a phase 1 clinical trial in Canada, which established a safe, tolerable, non-hallucinogenic dose range for the use of low doses of psilocybin on an outpatient basis.

Diamond is also launching a phase 2 clinical trial to investigate low-dose psilocybin’s efficacy in treating generalized anxiety disorder, which affects seven million U.S. adults. That study will be conducted in Canada on a take-at-home basis and has received Health Canada approval.