Message from the Executive Director

Reflecting on Usona’s journey the past ten years since our founding, we are enlivened with a strong sense of optimism and determination to achieve our goals. Our collaborative efforts to advance scientific research, provide educational programs, and explore novel therapeutic approaches for mental health have positioned Usona with a strong foundation for the future.

As we progress through 2024, we are grateful for your support, which continues to be the driving force behind Usona Institute’s endeavors. Our mutual commitment to the convergence of science and human well-being propels us toward innovative solutions that hold the potential to create a positive impact on a global scale.

Looking back at our achievements, it's evident that together, we've made significant progress. The forthcoming report spotlights the remarkable milestones of 2023, showcasing the pivotal role played by our partners, supporters, scientific collaborators, and the passionate members of our team, all aligned towards a common mission – to provide access to affordable, effective, and safe new treatment options to those in greatest need.

Highlights

  • With the publication of our Phase 2 study for psilocybin in Major Depressive Disorder (MDD), we are proceeding with a Phase 3 (PSIL301) launch in early 2024.

  • We have successfully completed the first-in-human Phase 1 study for 5-MeO-DMT and are in planning for Phase 2 efficacy studies.

  • The Investigational Drug Supply Program and Medicinal Chemistry team supported global research within clinical and non-clinical programs, emphasizing our commitment to advancing scientific and therapeutic understanding psychedelic molecules.

  • We continue to build for the future. This, year we opened the doors to the Usona campus, a purpose-designed, vibrant space to foster collaboration, education, training, and synergy.

  • Training and education programs continue to expand in support of our clinical development and external education initiatives. We hosted three immersive educational programs and expanded the clinical therapeutics team to support our development programs and in preparation for future delivery of care.

As we navigate the exciting years ahead, your continued support is crucial as we work toward advancing our goals and making a meaningful difference in the lives of many.

Together, we look forward to the possibilities that the future holds and the transformative impact we can achieve.

With deep gratitude,


Drug Development Programs

Trailblazing New Frontiers in Mental Health


2023 marked a year of significant progress in our drug development programs. We designed the Phase 3 psilocybin study, PSIL301, advancing our commitment to an accelerated path to FDA approval. The initiation and completion of the first-in-human Phase 1 safety study with 5-MeO-DMT signals a new chapter in psychedelic research.


Advancing Science

Innovation Through Collaborative Excellence


The Medicinal Chemistry team's publication on the asymmetric synthesis of unique compounds showcases our commitment to scientific discovery, in collaboration with leading researchers globally. The Investigational Drug Supply Program, featuring a validated tracking system and numerous shipments to collaborators globally, highlights our impact in advancing the field of psychedelic science.


Education Programs

Enhancing Knowledge, Engaging Practitioners


In 2023, Usona Institute expanded its education programs, hosting over 200 attendees at its new campus, cultivating a new generation of leadership in clinical research and future delivery of care. We also developed the Phase 3 Clinical Facilitator Manual and Training program to prepare facilitators for the Phase 3 clinical trial in 2024.


Outreach & Communications

Building Bridges, Expanding Horizons


Among the notable accomplishments of Usona's Outreach and Communications efforts, the Journal of the American Medical Association (JAMA) paper on Usona’s Phase 2 trial of psilocybin in Major Depressive Disorder (MDD) received widespread media attention and professional acclaim. The team's engagement in various sectors highlights our dedication to disseminating knowledge and fostering a community of learning and innovation.


Building for the Future

Making Space for Psychedelic Therapy, Education, and Discovery


The completion of the Usona Institute Campus in 2023 further demonstrates our commitment to creating a foundation for research and education in the growing field of psychedelic therapies.

Gratitude to our supporters and collaborators

Usona Institute is a non-profit medical research organization created to serve the public good. It is only because of our generous community of supporters and partners that we can continue our progress toward making a difference in mental health outcomes. We are grateful to all the individuals and organizations that enable our mission.

 

Major Supporters

Family Foundations

 

 Scientific Collaborators and Partner Organizations