Providing Answers for the Most Common Questions About Usona Institute

About Usona

When and why was Usona Institute founded?

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.

What is Usona’s role in psilocybin or other related research?

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.

What is a Medical Research Organization (MRO)? Why is Usona a non-profit MRO?

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.

What is Usona’s expertise in this field?

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.

How can I support the work of Usona Institute?

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.

How do I apply for a job or internship?

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

About Usona Sponsored Studies

What trials are Usona Institute currently involved in and how long will they take?

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

How can I enroll in a Usona Institute Clinical Trial?

To view our open trials and qualifications for enrollment please visit our Clinical Trials page for detailed information.

What is Expanded Access/Compassionate Use?

For patients facing a serious or life-threatening condition who are unable to participate in a clinical trial and have exhausted all other options, FDA or the overseeing regulatory authority in your country may allow a licensed physician to provide their patient with an unapproved drug. In the US, this is called “Expanded Access” and elsewhere has been referred to as “Compassionate Use.”

Please contact us to learn about our Expanded Access Policy.

About Our Psilocybin

How is it being produced?

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.

Who can access these materials?

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.

Do you intend to provide this substance publicly?

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.

About Facilitator Training

What is a Clinical Facilitator, and what is their role in Usona’s studies?

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.