Message from the Executive Director

Dear Supporters and Collaborators,  

As we reflect on 2024, I am filled with gratitude for the strides we have made together in advancing Usona’s mission to revolutionize mental health through research and innovation. This year, our efforts have resonated across every area of focus—from clinical trials to educational outreach and the strengthening of our global collaborations. Each milestone brings us closer to providing safe, effective, and accessible treatments to those in need. 

Our shared accomplishments are driven by the unwavering dedication of our community. Thanks to your support, we have advanced to Phase 3 of our psilocybin study and laid the groundwork for Phase 2 of our 5-MeO-DMT program. Together, we have broadened the reach of our educational initiatives, engaging with leadership and faculty at the forefront of scaling for future delivery of care, and reinforced our commitment to the highest standards of safety, efficacy, and integrity. 

Looking ahead, the promise of our work continues to inspire and energize us. With your partnership, we are building on this momentum—pioneering new frontiers in psychedelic science and therapeutic care. Your belief in our mission helps to fuel the transformative potential of this journey, as we strive to create a future where mental health care is not just accessible for all but also contributes to the flourishing of humanity and our planet.      

2024 Highlights

  • Initiated Phase 3 Study of Psilocybin for Major Depressive Disorder:
    Launched Phase 3 of our psilocybin study, uAspire (PSIL301), with expanded site activations across the U.S. and on-going engagement with the European Medicines Agency (EMA) to align with global regulatory standards, advancing progress toward regulatory submission. The study emphasizes collaboration with Veterans Affairs (VA) sites and specific initiatives focused on ensuring a diverse and representative participant population. 

  • Advanced the 5-MeO-DMT Program:
    Completed preparations for the Phase 2 efficacy study, including protocol development, Investigator’s Brochure (IB), and trial launch planned for mid-2025. 

  • Expanded the Investigational Drug Supply Program:
    Supported seven new research institutions and delivered to Singapore and Japan as new regulatory jurisdictions for this program.

  • Enhanced Education Programs:
    Hosted over 300 participants at ten educational events for immersive programs, workshops, and practitioner training, in partnership with leading educational institutions to support the understanding and preparation of leadership and practitioners for future delivery of care.

  • Strengthened Quality Assurance Capabilities:
    Enhanced the vendor audit system, refined the digital document control platform, and introduced specialized training modules to maintain accepted best practices in quality and compliance.

  • Broadened Global Outreach and Partnerships:
    Increased engagement with thought leaders and communities to foster support for psychedelic research and equitable access to emerging therapies. This included support of additional scholarships promoting diversity, cultural humility, and equitable access in psychedelic sciences.

Thank you for your continued support, your trust in our vision, and your role in this collective effort to create life-changing opportunities for healing and growth. Together, we are shaping a brighter, more compassionate future.

With deep gratitude,

Drug Development Programs

Opening New Frontiers in Mental Health

In 2024, Usona achieved significant advancements in drug development, highlighted by the launch of the Phase 3 psilocybin study for Major Depressive Disorder (PSIL301) and progress in the 5-MeO-DMT program. Expansion of trial sites in North America enhanced patient diversity and data reliability. Ongoing regulatory engagement with the FDA and EMA supports these efforts with potential for global regulatory submissions in 2026.

Advancing Science

Innovation Through Collaborative Excellence

Usona advanced psychedelic science in 2024 through strategic partnerships and innovation in medicinal chemistry, making strides in compound synthesis and receptor-specific research. The Investigational Drug Supply Program supported seven new research institutions and delivered to two new countries — Singapore and Japan.  

Education Programs

Enhancing Knowledge, Engaging Community

In 2024, Usona expanded its education programs with immersive workshops and practitioner training at its campus, hosting over 300 attendees at ten events. Collaborations with leading educational institutions enriched the curriculum, equipping practitioners with the skills and insights essential for advancing psychedelic therapies. These programs reflect Usona’s dedication to fostering a knowledgeable community prepared to lead in the future delivery of psychedelic therapies. 

Partnerships & Outreach

Building Bridges, Expanding Horizons

Usona broadened its outreach through strengthened connections with advocacy groups, Key Opinion Leaders, and the scientific community, fostering greater support for psychedelic research. Key efforts included participation in scientific and regulatory forums, as well as hosting educational events that promoted dialogue and understanding of innovative mental health solutions, including exploring aspects of Set and Setting, and the intersection of indigenous practices with modern clinical practices. These initiatives reflect Usona’s dedication to expanding the impact of psychedelic therapies within mental health and scientific fields.

Building for the Future

Making Space for Psychedelic Therapy, Education, and Discovery

Usona’s campus continued to serve as a vibrant center for education, research, and collaboration in 2024. Designed to support immersive learning experiences, the campus offers specialized treatment rooms and versatile group spaces that accommodate a range of programs. Built with sustainability in mind, the campus infrastructure reflects Usona’s commitment to environmental responsibility and sets the stage for the development of best practices in psychedelic therapies and continuing education in the years to come.