MADISON, Wis.--(BUSINESS WIRE)--Usona Institute has published a breakthrough technique in kilogram-scale synthesis of pharmaceutical grade psilocybin in the open-access journal ACS Omega. The scalability, controllability, and reproducibility in this newly developed procedure demonstrate that a classic reaction can produce pharmaceutical-grade psilocybin at a large scale in fewer steps.
“The combination of simplicity, stability and quality from this process is elegant,” says Gary Tarpley, Chairman of the Scientific Advisory Board at Usona. “We are fortunate to have medicinal chemists and a manufacturing partner that could take a whole new view on the problem in finding an answer that we hope will serve many in this field.”
This work is now available to current Good Manufacturing Practices (cGMP) manufacturing labs. Making this discovery publicly available is the result of Usona’s Open Science commitment to advance scientific knowledge in the field. Usona is currently providing cGMP psilocybin to qualified researchers, at no cost, through its Investigational Drug Supply Program to advance scientific and medical understanding of the psychoactive compound. The 1.2 kilograms of psilocybin per batch that this process delivers can be used to provide nearly fifty thousand 25-milligram doses of psilocybin.
As an FDA drug sponsor, Usona is investigating the therapeutic potential of psilocybin in the treatment of major depressive disorder (MDD) in a Phase 2 clinical trial, PSIL201, currently underway. Usona is responsible for the initiation, management, and regulatory aspects of the clinical trial toward FDA new drug approval, as well as the production of cGMP psilocybin that is tested for safety and purity under highly controlled and monitored conditions. For more information on this study, please visit www.usonaclinicaltrials.org.
Usona Institute is a 501(c)(3) nonprofit medical research organization (MRO) that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Its focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.