USONA INSTITUTE INC
Programs
Psilocybin Research Initiatives
CONDUCTS AND SUPPORTS PRE-CLINICAL AND CLINICAL RESEARCH TO FURTHER THE UNDERSTANDING OF THE THERAPEUTIC EFFECTS OF PSILOCYBIN, 5-MEO-DMT, AND OTHER CONSCIOUSNESS-EXPANDING MEDICINES. UNIVERSITY OF WISCONSIN HOSPITALS AND CLINICS (UW) SERVES AS A CLINICAL RESEARCH CENTER ASSOCIATED WITH THE UNIVERSITY OF WISCONSIN-MADISON. THERE ARE SEVERAL USONA COLLABORATIONS WITH THE UW THAT INCLUDE RESEARCHERS AND STAFF UNDER APPOINTMENT WITH THE HOSPITAL. USONA HAS CONTRACTED SAFETY AND EFFICACY CLINICAL STUDIES WITH THE UW FOR OUR DRUG DEVELOPMENT PROGRAMS, OFFERS INTERNSHIPS, FUNDS UW SCHOLARSHIPS, AND IS BUILDING A FUTURE TRAINING PROGRAM FOR CLINICAL FACILITATORS IN PARTNERSHIP WITH THE UW.GeographiesNot indicatedDatesJan 1, 2022 – Dec 31, 2022Source990No causes providedNo populations provided–$14.9MProgram 1 [2024]
PSIL301 STUDYUSONA INSTITUTE IS CONDUCTING A PHASE 3 CLINICAL TRIAL, "A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PSILOCYBIN IN ADULTS WITH MAJOR DEPRESSIVE DISORDER (MDD)," ALSO KNOWN AS THE UASPIRE TRIAL. THIS RESEARCH SEEKS TO INVESTIGATE THE POTENTIAL BENEFITS AND SAFETY OF PSILOCYBIN AS A TREATMENT OPTION FOR INDIVIDUALS WITH MAJOR DEPRESSIVE DISORDER AS QUICKLY AND SAFELY AS POSSIBLE.2024 ACCOMPLISHMENTSTHE UASPIRE PSIL301 PHASE 3 TRIAL ADDED NEW SITES ACROSS NORTH AMERICA, INCLUDING VETERANS AFFAIRS (VA) SITES, TO ENHANCE PATIENT DIVERSITY AND STRENGTHEN DATA RELIABILITY TO SUPPORT REGULATORY APPROVAL AND ENSURE BROAD APPLICABILITY OF FINDINGS. ONGOING COLLABORATION WITH THE FDA UNDER OUR BREAKTHROUGH THERAPY DESIGNATION, IN PREPARING FOR NDA SUBMISSION UPON COMPLETION OF PHASE 3. THE CMC TEAM SCALED UP API PRODUCTION, MAINTAINED STRINGENT QUALITY CONTROLS, AND SECURED NEW MANUFACTURING PARTNERSHIPS TO SUPPORT HIGH-QUALITY PSILOCYBIN PRODUCTION IN ANTICIPATION OF MARKET ACCESS. FACILITATOR TRAINING EXPANDED ACROSS ALL PHASE 3 SITES TO ENSURE CONSISTENT IN-PATIENT CARE. EARLY MARKET ACCESS EFFORTS INCLUDED PARTNERSHIPS WITH DIVERSE STAKEHOLDERS FOCUSING ON UNDERSERVED POPULATIONS, ENHANCING INFRASTRUCTURE AND SUPPLY CHAIN RESILIENCE FOR EQUITABLE ACCESS.GUIDED BY A DIVERSITY STEERING COMMITTEE, THE PLAN INCORPORATED INSIGHTS FROM COMMUNITY OUTREACH AND DIVERSITY EXPERTS TO RECRUIT UNDERREPRESENTED POPULATIONS AND FOSTER INCLUSION IN THE PSIL301 PHASE 3 STUDY.GeographiesNot indicatedDatesJan 1, 2024 – Dec 31, 2024Source990No causes providedNo populations provided–$27.7MProgram 2 [2024]
5-MEO-DMT PHASE 2 STUDYUSONA INSTITUTE IS CONDUCTING A TWO-PART (PHASE 2A/2B) CLINICAL TRIAL (MEO201) TO EVALUATE THE EFFICACY AND SAFETY OF 5-MEO-DMT FOR THE TREATMENT OF POST-TRAUMATIC STRESS DISORDER (PTSD) IN ADULTS. THE GOALS IN PART A (PHASE 2A) ARE TO OBTAIN SAFETY DATA AND EFFECT SIZE ESTIMATES IN A PTSD PATIENT POPULATION AND GAIN KNOWLEDGE AND EXPERIENCE TO OPTIMIZE PART B (PHASE 2B) DESIGN. THE GOAL IN PART B (PHASE 2B) IS TO EVALUATE THE SAFETY AND EFFICACY OF THE 5-MEO-DMT REGIMEN SELECTED FROM PART A. 2024 ACCOMPLISHMENTSREFINED PHASE 2 PROTOCOLS USING PHASE 1 DATA, OPTIMIZING SAFETY AND DOSING TO IMPROVE PATIENT OUTCOMES. INITIATED SITE SELECTION AND DEVELOPING FACILITATOR TRAINING PROGRAM TO ENSURE HIGH STANDARDS AND TRIAL QUALITY. PLANNING FOR A 2025 TRIAL LAUNCH TO EVALUATE 5-MEO-DMT'S EFFICACY WITH MULTIPLE SITES IN THE U.S. AND CANADA.GeographiesNot indicatedDatesJan 1, 2024 – Dec 31, 2024Source990No causes providedNo populations provided–$3.1M
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