Usona

The National Institutes of Health (NIH) under the Department of Health and Human Services has issued a Special Notice for a sole source procurement from Usona Institute. This 8(a) sole source opportunity involves the acquisition of psilocybin, a Schedule I controlled substance, to support an NIH/NIA-sponsored clinical research study. The study will examine the potential benefits of psilocybin-assisted cognitive training in healthy older adults and individuals with Alzheimer's disease. The Notice was posted on July 25, 2025, with responses due by August 9, 2025. This procurement falls under the biotechnology research and development sector and professional support services categories.

The primary objective of this Special Notice is to procure the investigational drug product necessary to conduct a clinical trial investigating psilocybin's therapeutic potential in cognitive enhancement for aging populations. The procurement is structured as a sole source award because Usona Institute is uniquely positioned as the only U.S.-based non-profit organization that possesses the required Drug Enforcement Administration licensure, GMP manufacturing capabilities, and suitable IND-enabling materials for NIH-sponsored human trials. Additionally, Usona holds an existing Investigational New Drug (IND) application that the NIA can cross-reference in their own FDA submission. Given the highly regulated nature of Schedule I substances, the limited number of qualified manufacturers authorized to produce psilocybin under Good Manufacturing Practice conditions for human research creates a restricted supplier pool. The procurement supports the scientific aims of the clinical study by providing the primary investigational product required for the research protocol.