Entropy Neurodynamics Doses First Patient in Groundbreaking IV Psilocin BED Trial
Entropy Neurodynamics has successfully administered its proprietary IV-infused psilocin, TRP-8803, to the first patient in a clinical trial targeting Binge Eating Disorder, marking a world first in neuropsychiatric treatment.
- First patient safely dosed with TRP-8803 in Binge Eating Disorder trial
- Trial involves 12 patients across two dosing cohorts with supportive therapy
- IV infusion allows precise control over psychedelic experience duration and intensity
- Top-line results expected in the first quarter of 2026
- Second patient progressing through baseline assessments for January dosing
A Clinical Milestone in Psychedelic Therapy
Entropy Neurodynamics Limited (ASX – ENP) has announced a significant advancement in its clinical development program with the successful dosing of the first patient using TRP-8803, an intravenous formulation of psilocin, in a trial for Binge Eating Disorder (BED). This event marks the world’s first clinical use of IV-infused psilocin in a neuropsychiatric condition, underscoring the company’s pioneering role in precision psychedelic therapies.
The patient received a mid-range therapeutic dose administered over 140 minutes, allowing clinicians to finely tune the onset, depth, and duration of the psychedelic experience. This level of control is a notable improvement over traditional oral psilocybin treatments, which can be less predictable and harder to manage in clinical settings.
Trial Design and Progress
The BED trial is structured to recruit 12 patients divided into two cohorts of six. Each participant will receive two doses of TRP-8803 spaced 14 days apart, combined with supportive therapy to enhance treatment outcomes. The first cohort is receiving a mid-range dose, while the second will be administered a higher dose, providing comparative data on safety and efficacy.
Following the initial dosing, the patient was discharged after completing follow-up assessments and will continue with supportive therapy before receiving a second dose in mid-December. Meanwhile, the second patient is progressing well through baseline assessments, with dosing anticipated in January 2026. Recruitment efforts remain active, with additional enrolments expected soon.
Implications for Neuropsychiatric Treatment
CEO Jason Carroll highlighted the importance of this milestone, emphasizing the company’s ability to execute its clinical strategy after four years of scientific development in collaboration with Swinburne University. He noted that TRP-8803’s controlled infusion profile not only enhances patient safety but also improves therapeutic predictability, a critical factor for broader commercial adoption.
Previous Phase 2a trials using Entropy’s oral psilocybin formulation, TRP-8802, demonstrated promising results, including an average reduction of over 80% in binge eating episodes. TRP-8803 aims to build on this foundation by offering a more precise and scalable delivery method, potentially transforming treatment paradigms for BED and other neuropsychiatric conditions.
Looking Ahead
Top-line results from the BED trial are expected in the first quarter of 2026, which will provide critical insights into the safety, tolerability, and therapeutic benefits of TRP-8803. The company is also advancing trials in fibromyalgia and irritable bowel syndrome, further positioning itself at the forefront of psychedelic-assisted therapies.
Bottom Line?
As Entropy Neurodynamics advances its novel IV psilocin therapy, the upcoming trial results will be pivotal in shaping the future of neuropsychiatric treatment.
Questions in the middle?
- Will TRP-8803 demonstrate superior efficacy and safety compared to oral psilocybin in BED treatment?
- How quickly can Entropy Neurodynamics scale production and clinical deployment if results are positive?
- What regulatory hurdles remain for IV-infused psilocin therapies in neuropsychiatric indications?
