Usona Impact (original) (raw)

Dear Friends and Partners,

At Usona Institute, our work is driven by a commitment to open science, compassionate care, and the goal of bringing meaningful relief to those facing society’s most challenging mental health conditions. As we reflect on the progress detailed in this 2025 Impact Report, I am filled with optimism for the future of psychedelic research and deep gratitude for the community that makes this mission possible.

Thanks to our supporters, 2025 has been a year of momentum:

• Completion of enrollment in our Phase 3 clinical program, advancing the uAspire study toward regulatory submission. The trial enrolled participants across 30 clinical sites throughout the U.S., including four Veterans Affairs medical centers, bringing potential relief closer to people who serve and those who care for them.
• Strong policy-level engagement to advance evidence-based research, ensuring therapeutic options reach communities, and enhance human well-being and flourishing.
• Productive engagement with the FDA throughout 2025, including a Type B meeting that provided valuable guidance for our regulatory submission preparation.
• Global scientific collaborations across 16 countries that enable research in a number of indications, extending our open science mission.
• Expanded immersive education programs for healthcare leaders, researchers, faculty, and clinicians preparing for future delivery of care.
• Meaningful progress in diversity and inclusion, with clinical trial enrollment reflecting strong representation from underrepresented racial and ethnic groups, supported by strategic partnerships, and expanded scholarship programs.
• Advanced manufacturing readiness with completion of commercial-scale validation batches, regulatory inspection-ready manufacturing partners, and comprehensive quality management systems supporting future patient access.

These milestones would not be possible without collaborators, major supporters, and dedicated partner organizations. Thank you for your shared commitment to advancing mental health, human flourishing, and transformative science.