Frequently asked questions

Usona was founded in 2014 by Bill Linton and Malynn Utzinger, MD, in Madison, Wisconsin. It all started with an inspiring event for co- founder Bill Linton. Bill witnessed the transformation of a friend and neighbor who participated in a Johns Hopkins study for people with terminal cancer. She went from a state of depression and chronic anxiety to one of lasting ease and calm. Today, there are approximately 30 full- and part-time employees and consultants.

Usona is a commercial sponsor, which means that we hold responsibility for all aspects of our drug development programs, including study designs and protocols, data and safety monitoring, and overseeing all preclinical and clinical studies. This is a direct level of engagement with the work, and it differs from foundations and grant-making entities that strictly provide financial support.

Usona is structured as a 501(c)(3) non-profit medical research organization. An MRO is a specific type of 501(c)(3) non-profit organization, designed to be engaged in the continuous active conduct of medical research. As a non-profit, Usona relies on a number of generous donors to fund our present and future operations.

Usona’s purpose and commitment is to serve the public good through scientific rigor and discovery. Guided by this purpose, Usona works with an approach that values scientific integrity and transparency for the benefit of society by striving to place our research results in the public domain. Our research is not led by the desire for commercial gain, but by the scientific inquiries that point toward the development of promising medicines and therapeutic frameworks for those in need.

The Usona team members and external consultants hold a depth of expertise and experience on depression, psychedelics, facilitation, conducting clinical studies, developing pharmaceutical-grade products, and working with the FDA. Members of the Usona team regularly collaborate and engage with global thought leaders in a variety of scientific fields.

Your support is very appreciated, and we welcome your donation to Usona Institute. If you have questions about giving to Usona Institute, please contact us at philanthropy@usonainstitute.org.

If you are curious about career offerings at Usona Institute, please visit our careers page.

A full list of clinical trials Usona Institute are currently sponsoring in can be viewed on our Drug Development Overview page.

Enrollment for Usona Institute’s phase 3 clinical trial, uAspire – “A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder” – is now closed, and we are no longer accepting new participants. We sincerely appreciate your interest in uAspire and look forward to sharing the study results after completion. If you are interested in future clinical trial opportunities, please visit www.clinicaltrials.gov or check the Usona Institute website (https://www.usonainstitute.org/) for the most up-to-date information about any new studies that may become available.

Please email clinicaltrials@usonainstitute.org to request a site application.

Clinical Facilitators play a central role in ensuring participant safety throughout a study. Facilitators are responsible for 1) preparing each participant for his, her, or their dosing session; 2) monitoring the participant’s physical and psychological well-being throughout the dosing session; and 3) supporting the participant throughout the integration sessions following the dosing session.

Usona Institute does not offer expanded access of psilocybin or 5-MeO-DMT at this time. To view our open clinical trials and qualifications for enrollment please visit our Clinical Trials page for detailed information.

Usona's investigational products are synthesized under cGMP conditions in a tightly controlled setting. We do not use natural resources such as mushrooms to manufacture these materials. The cGMP process ensures purity and consistency.

Qualified researchers conducting clinical research under the regulations of the FDA or other competent authority may submit a request for investigational product to the IDMSP. To learn more, see our Investigational Drug Supply Program.

Pending FDA approval, we intend that the psilocybin would be made available as part of a carefully devised and controlled therapeutic protocol, administered by trained therapists. It would not be given to a patient/client for home or independent use.