Toronto-based psychedelic drug development company Diamond Therapeutics has received FDA approval for a human clinical trial conducted at the University of Alabama in Birmingham.

This trial aims to determine the feasibility and effectiveness of low doses of psilocybin in patients experiencing moderate to severe demoralization. The doses administered will be low enough to avoid causing hallucinogenic or transcendent effects in the 60 patients participating. The trial will last five weeks and will involve randomized, double-blind, and placebo-controlled methods. The current research study is based on the findings of Diamond's Phase I clinical trial, which was carried out under the regulations of Health Canada. 

Diamond Therapeutics is a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health. The company’s first clinical program focuses on accessible psilocybin-based drugs that deliver rapid therapeutic outcomes without perceptual side effects. Further, Diamond will be conducting a Phase II clinical trial to investigate low-dose, psilocybin efficacy in treating generalized anxiety disorder (GAD). This Phase II study has received Health Canada approval and will be conducted in Canada on a take-at-home basis. The company has a diverse pipeline of tryptamine analogs and small organic molecules that act by modulating selective serotonin receptors and neurotrophic receptor signaling.