Entropy Neurodynamics (ASX:ENP) has marked a significant clinical milestone, successfully administering the first dose of its proprietary psilocin formulation, TRP-8803, in a trial targeting binge eating disorder (BED).
The Melbourne-based clinical-stage biotechnology company confirmed the dosing occurred on 1 December 2025, describing it as the first-ever clinical use of IV-infused psilocin in a neuropsychiatric condition.
The trial, conducted with Swinburne University, will recruit 12 participants across two six-person cohorts, each receiving two doses of TRP-8803 spaced 14 days apart alongside supportive therapy.
The first patient received a therapeutic mid-range infusion over 140 minutes, with the intravenous delivery allowing clinicians to precisely modulate onset, depth and duration of the psychedelic experience, a level of control not possible with oral psilocybin. The participant was discharged after follow-up and will receive a second dose on 15 December.
Recruitment for additional participants is underway, with the company confirming baseline assessments are progressing for a second patient expected to be dosed in January.
Entropy Neurodynamics CEO Jason Carroll said the achievement represents “a major clinical and operational milestone,” following four years of scientific development. “This development follows 4 years of scientific development, extensive work alongside Swinburne University and demonstrates our capability to execute on our clinical strategy.”
He added that TRP-8803’s precision-controlled infusion profile is central to the company’s strategy of delivering scalable and predictable psychedelic-assisted treatments. “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.”
The TRP-8803 program builds on promising results from earlier studies using the company’s oral psilocybin formulation, TRP-8802, which achieved an average reduction of more than 80 per cent in binge eating episodes in Phase 2a trials. The controlled IV delivery used in TRP-8803 is designed to reduce variability, shorten intervention times and improve commercial feasibility for large-scale clinical adoption.