First Patient Dosed with IV Psilocin in Groundbreaking Binge Eating Disorder Trial
Key Insights
Entropy Neurodynamics (search) successfully administered the first clinical dose of TRP-8803, an intravenous psilocin formulation, to treat binge eating disorder (search) on December 1, 2025.
The Phase 2 trial represents the first-ever clinical use of IV-infused psilocin in a neuropsychiatric condition, offering precise control over onset, depth and duration of treatment.
The study builds on promising Phase 2a results with oral psilocybin that achieved over 80% reduction in binge eating episodes.
Entropy Neurodynamics (search) has achieved a significant clinical milestone by successfully administering the first dose of TRP-8803, its proprietary intravenous psilocin formulation, to a patient with binge eating disorder (search) (BED) on December 1, 2025. This marks the first-ever clinical use of IV-infused psilocin in a neuropsychiatric condition, representing a potential breakthrough in psychedelic-assisted therapy.
Clinical Trial Design and Progress
The Phase 2 trial, conducted in partnership with Swinburne University (search), will recruit 12 participants across two six-person cohorts. Each participant will receive two doses of TRP-8803 spaced 14 days apart, alongside supportive therapy. The first cohort receives a mid-range dose, while the second cohort will receive a higher dose as part of the dose-escalation design.
The first patient received a therapeutic mid-range infusion over 140 minutes and was discharged after follow-up monitoring. The participant is scheduled to receive their second dose on December 15. A second patient has begun the four-week baseline assessment period and is expected to be dosed in January 2026.
Precision-Controlled Delivery Advantage
TRP-8803's intravenous delivery system allows clinicians to precisely modulate the onset, depth, and duration of the psychedelic experience—a level of control not achievable with oral psilocybin formulations. This precision-controlled infusion profile is designed to reduce variability, shorten intervention times, and improve commercial feasibility for large-scale clinical adoption.
"This level of dose control is critical for ensuring patient safety, enhancing therapeutic predictability and advancing our broader goal of bringing first-in-class neuropsychiatric therapy into late-stage development," said Entropy Neurodynamics (search) CEO Jason Carroll.
Building on Promising Preclinical Results
The TRP-8803 program builds on encouraging results from the company's earlier Phase 2a study using its oral psilocybin formulation, TRP-8802. That trial achieved an average reduction of more than 80% in binge eating episodes, providing strong rationale for advancing to the intravenous formulation.
Addressing Significant Unmet Medical Need
The trial addresses a substantial healthcare challenge, with more than 230,000 Australians experiencing BED in any given year, according to Dr. Jim Hungerford, CEO of the Butterfly Foundation (search), Australia's leading organization for eating disorders. The Foundation is supporting patient recruitment through community-based awareness and engagement efforts.
"Further research into Binge Eating Disorder (search) and additional treatment options is critical to breaking down stigma and encouraging help-seeking," Hungerford noted. "We look forward to seeing the results of this world-first clinical trial."
Timeline and Next Steps
Recruitment for additional participants is underway, with several prospective participants progressing through the screening process. The baseline assessment period includes evaluations of binge-eating behavior, body mass index, vital signs, laboratory testing, neuropsychiatric assessments, and safety measures. Top-line results from the trial remain on track for the first quarter of 2026.
Carroll described the achievement as "a major clinical and operational milestone" following four years of scientific development and extensive collaboration with Swinburne University (search), demonstrating the company's capability to execute on its clinical strategy for scalable and predictable psychedelic-assisted treatments.