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Usona Institute is a non-profit medical research organization focused on studying the therapeutic use of psilocybin and other consciousness-expanding medicines. It conducts and supports both pre-clinical and clinical trials to understand how these substances can relieve depression and anxiety in patients who do not respond well to existing treatments. The research typically involves administering psilocybin in controlled clinical settings with professional medical oversight and psychotherapy to explore its potential benefits and risks. Unlike for-profit biotech firms, Usona centers on advancing scientific knowledge and patient care, prioritizing safety, accessibility, and transparency. Its goal is to develop evidence-based psychedelic therapies that can help people achieve a better quality of life when conventional treatments fall short.
Industries
Social Impact
Biotechnology
Healthcare
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Fitchburg, Wisconsin
Founded
2014
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FDA moves to fast-track psychedelic drugs after Trump order. The U.S. Food and Drug Administration said on Friday it is taking steps to speed up the development of new treatments for serious mental illness such as depression, following an executive order signed by President Donald Trump last week. The executive order directed the FDA to give commissioner's national priority vouchers to psychedelic drugs that have the "breakthrough therapy" tag, potentially cutting the review time to one to two months from the usual six to 10 months. About 23.4% of U.S. adults experienced mental illness in 2024, while 17.6% of U.S. veterans did so in 2023, according to the National Alliance on Mental Illness. The health regulator said it would issue national priority vouchers to three companies developing psychedelic treatments. Of the three companies, two are studying psilocybin for treatment-resistant depression and major depressive disorder, and another is studying methylone for post-traumatic stress disorder. "These medications have the potential to address the nation's mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions," FDA Commissioner Marty Makary said in a statement. While the FDA did not disclose the names of the companies, Compass Pathways is developing a synthetic form of psilocybin for treatment-resistant depression, Usona Institute is studying psilocybin for major depressive disorder and Transcend Therapeutics is developing methylone as a potential treatment for PTSD. Compass, Usona and Transcend did not immediately reply to Reuters' requests for comment. Ibogaine is the only psychedelic mentioned in the executive order, though LSD, MDMA and psilocybin are also being studied in large U.S. trials for various mental health conditions. Both psilocybin and ibogaine are listed as Schedule I drugs, meaning they currently have no accepted medical use and a high potential for abuse, according to the Drug Enforcement Administration. The FDA also cleared the way for the first human trial in the United States of noribogaine, a derivative of ibogaine. Ibogaine is derived from a shrub native to Africa. Reporting by Kamal Choudhury in Bengaluru; editing by Shilpi Majumdar.
RAMLOW/STEIN project, The Usona Institute, located in Fitchburg, just won an AIA Wisconsin Special Recognition Award for outstanding achievement in sustainability.
US-based medical research organization the Usona Institute launched its Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of psilocybin in adults with major depressive disorder (MDD).
MADISON, Wis.--(BUSINESS WIRE)--Usona Institute announces the launch of its Phase 3 clinical trial, titled "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD)." Known as the uAspire trial, its launch represents the beginning of an important next stage in the development of psilocybin as a potential therapeutic option for those diagnosed with MDD. "The initiation of the Phase 3 uAspire trial marks an important milestone in the clinical development of psilocybin as a potential new treatment for major depressive disorder," says Dr. Mike Davis, Chief Medical Officer at Usona Institute. "Following the robust safety and efficacy findings from our Phase 2 study PSIL201, the uAspire trial is designed to deepen our understanding of psilocybin’s treatment durability and long-term safety. To ensure broad applicability of the study findings, we are committed to the inclusion of adults from diverse backgrounds and treatment settings, including top academic institutions, clinical research sites, and VA medical centers across the country.”. ClinicalTrials.gov Identifier: NCT06308653
Usona Institute announces launch of uAspire Phase 3 clinical trial investigating psilocybin for Major Depressive Disorder.
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Industries
Social Impact
Biotechnology
Healthcare
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Fitchburg, Wisconsin
Founded
2014
Find jobs on Simplify and start your career today