The Usona Institute is a US-based not-for-profit medical research organization (MRO) formed in 2014 dedicated to exploring psilocybin as a potential therapeutic treatment for mental conditions such as depression and anxiety. In November 2019, Usona was granted Breakthrough Therapy Designation by the FDA for psilocybin to treat major depressive disorder (MDD), and it operates two approved chemistry research facilities in the US.
The institute collaborates with experts such as scientists, medical researchers, clinicians, and research organizations, including Imperial College London, the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation, and the Heffter Research Institute, for the clinical development of psilocybin and other psychedelic-based therapeutics. As of May 2021, the institute initiated a Phase 2 clinical trial in seven sites across the US, expecting close to 80 (MDD) patients. The Phase 2 clinical trial is expected to take between one and one and half years and based on the trial’s success, a Phase 3 study will be initiated.
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