Usona Institute
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.
Manufacturing Snapshot
Research-Led (Partner Manufacturing)Scope & Capabilities
Supply Use Cases
GxP / Compliance
Facilities & Access
Non-profit research model coordinating investigational drug supply through regulated development pathways.
Manufacturing DetailsSupported Substances
Psilocybin investigational supply and quality/CMC coordination in support of clinical trial programs.
Manufacturing Sources
Development Programmes
2Psilocybin (25 mg)
PsilocybinSynthetic psilocybin (25 mg oral, single dose) for major depressive disorder, administered with psychosocial support. FDA Breakthrough Therapy Designation (November 2019). Phase 2 (PSIL201): 104 adults, rapid and sustained antidepressant effect vs active placebo; published JAMA September 2023. Phase 3 uAspire (PSIL301, NCT06308653): ~240 adults, 6-week double-blind + 12-month follow-up. Developed by a non-profit — no commercial pricing pressure.
Programme Tracker
Major Depressive Disorder (MDD)
Forecast
nda-submission - Approval eventual: 55%
uAspire (NCT06308653) ongoing — enrolling ~240 adults at US sites including VA. NDA submission targeted 2026 upon Phase 3 completion.
Milestones
Phase II topline
CompletedActual: Sep 5, 2023
Phase 2 PSIL201 results published in JAMA: single 25 mg psilocybin dose produced rapid, sustained antidepressant effect vs active placebo over 6 weeks (n=104)
Why it matters: JAMA publication provides the strongest evidence base for the Phase 3 programme; high-profile journal validates the clinical approach
Watch next: Phase 3 uAspire enrolment and completion
Phase III started
CompletedActual: Mar 19, 2024
Phase 3 uAspire study (PSIL301, NCT06308653) launched — ~240 adults, multi-site including VA, 6-week double-blind + 12-month follow-up
Why it matters: Pivotal study required for NDA submission; Usona's non-profit model means results will inform regulatory submissions without commercial licensing barriers
Watch next: Enrollment completion, topline results, NDA submission
Regulatory review accepted
CompletedActual: Nov 22, 2019
FDA granted BTD to Usona's psilocybin programme for MDD — one of the first psilocybin BTDs granted
Why it matters: BTD provides expedited development pathway and closer FDA collaboration; signals FDA recognition of unmet need in MDD
Watch next: Phase 2 results and Phase 3 launch
Recorded Events
Mar 19, 2024: Phase III started
Sep 5, 2023: Phase II topline
Nov 22, 2019: Regulatory review accepted
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
company-website - Usona Institute - Verified
5-MeO-DMT
5-MeO-DMTSynthetic 5-MeO-DMT (designated MEO201) for a planned Phase 2 efficacy study. GMP drug product manufactured; analytical testing and stability complete. Type B FDA meeting under BTD completed. Phase 2 protocol drafted; facilitator training model developed. Phase 2 initiation targeted mid-2025.
Programme Tracker
Depressive Disorders
IND-enabling studies complete; Phase 2 initiation targeted mid-2025. Protocol finalized, vendors selected.
Milestones
Pre-clinical completed
CompletedActual: Dec 1, 2024
GMP manufacturing of 5-MeO-DMT drug product complete; CMC documentation for IND finalized; Type B FDA meeting completed under BTD
Why it matters: IND-enabling package readies Usona for regulatory submission to initiate Phase 2
Watch next: IND submission and Phase 2 first patient dosing
Phase II started
PlannedLikely: Q3 2025
Phase 2 MEO201 study planned for mid-2025 initiation
Why it matters: Would be Usona's second clinical-stage programme; non-profit access model for 5-MeO-DMT distinct from commercial competitors
Watch next: IND submission and first patient dosing announcement
Recorded Events
Dec 1, 2024: Pre-clinical completed
Quick Facts
- Type
- Non-Profit
- Founded
- 2014
- Lead Stage
- Phase III
- HQ
- 2800 Woods Hollow Rd., Madison, WI, United States
- Website
- Visit