About

Usona Institute is a nonprofit medical research organization based in Madison, Wisconsin, dedicated to developing psilocybin as a medicine and making it broadly accessible. Unlike COMPASS Pathways (a commercial entity), Usona is structured as a public benefit organization that will not profit from its drug development activities.

Usona's primary current project is a Phase 2 clinical trial of psilocybin for major depressive disorder (not just treatment-resistant depression, but the broader MDD population). If successful, this trial would support an IND and eventual NDA for a non-commercial psilocybin product.

Usona's non-commercial structure matters for access equity: if their psilocybin formulation reaches FDA approval, they have explicitly committed to pricing strategies that prioritize broad patient access rather than shareholder returns — a significant difference from the commercial model.

Why It Matters

Usona represents the non-commercial path to FDA-approved psilocybin — ensuring that if synthetic psilocybin is approved, it isn't exclusively in the hands of pharmaceutical companies with profit-maximizing pricing. Their MDD trial expands the potential patient population beyond the treatment-resistant focus of most other trials.

State Legal Context

See current psilocybin laws in Wisconsin.