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Usona Institute

2800 Woods Hollow Rd., Madison, WI, United States
2 Drug Candidates22 Trials

Usona Institute is a US-based 501(c)(3) non-profit medical research organisation (MRO) headquartered in Madison, Wisconsin. Co-founded in 2014 by Bill Linton (CEO of Promega Corporation) and Malynn Utzinger, M.D., Usona was established after Linton witnessed the profound impact of a Johns Hopkins psilocybin study on a terminally ill friend. Unlike commercial drug developers, Usona operates as a mission-driven MRO — conducting and supporting pre-clinical and clinical research on psilocybin and other consciousness-expanding medicines, with the goal of developing accessible, affordable treatments. Its research leadership includes Dr. Charles Raison (Director of Clinical and Translational Research, UW-Madison psychiatrist) and Dr. Alexander Sherwood (medicinal chemist). Usona's psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study (the largest Phase 2 randomised controlled trial of psilocybin for MDD at the time), the Institute launched the Phase 3 uAspire trial in 2024 — a 240-participant, randomised, double-blind, multicentre study comparing 25 mg psilocybin vs placebo in adults with MDD. Usona is also exploring 5-MeO-DMT in early-stage research.

Drug Pipeline

2

Psilocybin (25 mg)

Psilocybin
Phase III

Synthetic psilocybin, single oral dose (25 mg) with psychosocial support. FDA Breakthrough Therapy Designation for MDD (2019). Phase 2 PSIL201 completed (randomised, double-blind, placebo-controlled). Phase 3 uAspire trial (NCT06308653) active: 240 participants, 5 mg or 25 mg psilocybin vs placebo, primary endpoint change in depressive symptoms at Day 43. Non-profit mission: pursuing accessible approval, not shareholder returns.

5-MeO-DMT

5-MeO-DMT
Pre-clinical

Early-stage research into 5-MeO-DMT as a consciousness-expanding medicine. No active clinical trial announced as of early 2026.

Quick Facts

Type
Non-Profit
Founded
2014
Lead Stage
Phase III
HQ
2800 Woods Hollow Rd., Madison, WI, United States
Website
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Sponsored Trials

5

Collaborated Trials

17