Research & Development
Ceruvia Lifesciences' synthetic psilocybin Phase two clinical trial receives US FDA approval
28 June 2022 -

Ceruvia Lifesciences, a US-based neurotransformational medicine biopharmaceutical company, announced on Monday that it has received approval from the United States Food and Drug Administration (FDA) for its Investigational New Drug application for a Phase two clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).

The company's phase two, multicentre, randomised, double blind, active placebo controlled clinical trial is intended to assess the safety and efficacy of synthetic psilocybin (SYNP-101) to treat patients with OCD symptoms.

The trial is to enrol a total of 105 subjects, who will receive 25mg of SYNP-101 or the active placebo, niaicin. The primary endpoint of the trial is to determine the decrease in OCD symptoms for up to 12 weeks after a single administration of SYNP-101. Efficacy of treatment will be evaluated utilising the Yale-Brown Obsessive Compulsive Scale. The trial is to start in the second half of 2022 and will be headed by principal investigators Dr Benjamin Kelmedi and Dr Christopher Pittenger of Yale University School of Medicine.

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