Entropy Neurodynamics Advances Psychedelic Therapy with First Patient Dosing Complete

Clinical Milestone Achieved in Psychedelic Therapy Trial

Entropy Neurodynamics Limited (ASX – ENP), a clinical-stage biotech innovating in psychedelic-assisted therapies, has announced the completion of dosing for the first patient in its TRP-8803 trial targeting Binge Eating Disorder (BED). The patient received a second intravenous infusion of TRP-8803, an IV formulation of psilocin, on 15 December 2025, marking a significant step forward in the company’s clinical program.

This trial, conducted in collaboration with Swinburne University, aims to recruit 12 patients divided into two cohorts receiving different dose ranges. The recently dosed patient belongs to the first cohort, which is receiving a mid-range dose. Each patient undergoes two infusions spaced 14 days apart, combined with supportive psychotherapy to enhance therapeutic outcomes.

Precision and Safety in Psychedelic Administration

Unlike traditional oral psilocybin treatments, TRP-8803 offers rapid onset, approximately 15 minutes, and precise control over the psychedelic experience’s depth and duration. This is achieved through intravenous infusion, which bypasses gastrointestinal metabolism and reduces variability in patient response. The patient’s full psychedelic response during the second infusion demonstrates the company’s ability to reliably induce therapeutic psychedelic states under clinical supervision.

Importantly, the Drug and Safety Monitoring Board (DSMB) has reviewed and cleared the safety of the dosing regimen following the first infusion, allowing the trial to proceed with additional patients in the first cohort. This regulatory oversight underscores the trial’s commitment to patient safety and rigorous clinical standards.

Next Steps and Broader Implications

Following the infusion phase, the patient will continue with supportive psychotherapy, with a post-treatment review scheduled for mid-January 2026. Entropy Neurodynamics expects to report top-line results from this initial cohort in the first quarter of 2026, which could provide valuable insights into TRP-8803’s efficacy and safety profile in treating BED.

CEO Jason Carroll highlighted the importance of this milestone, emphasizing the unique advantages of TRP-8803’s IV delivery system in delivering consistent, clinician-guided psychedelic therapy. The company is optimistic that positive data from this study will support further development of TRP-8803 across other neuropsychiatric conditions, including fibromyalgia and irritable bowel syndrome, where related trials are underway.

With its shorter session duration and controlled dosing, TRP-8803 aims to overcome key limitations of oral psilocybin therapies, potentially enabling more scalable and commercially viable psychedelic treatments in clinical settings.