Investigational Drug Supply Program

About this program

Usona Institute’s Investigational Drug Supply Program provides investigational drugs and research materials (including psilocybin products) and associated documentation—such as safety data sheets, certificates of analysis, and regulatory submission information—to support approved clinical and preclinical studies. Initial application requires a completed Usona Investigational Drug & Materials Request Form and a research summary on institutional letterhead describing dosing, study design/protocol, justification for the requested amount, and intended regulatory pathway. Following conditional approval, applicants must provide final protocol documents and appropriate approvals (e.g., informed consent, IRB/ethics, IACUC for animal work), applicable regulatory authorizations (e.g., FDA, MHRA, TGA), label approval where relevant, and controlled‑substance licensure/permits (psilocybin is a controlled substance in most countries). Usona does not provide protocol templates or clinical/regulatory advisement.