Tryptamine’s Psychedelic Therapy Faces Clinical and Regulatory Milestones Ahead
Tryptamine Therapeutics has initiated the world’s first clinical trial of its IV-infused psilocin drug, TRP-8803, targeting Binge Eating Disorder, alongside a pioneering EEG biomarker collaboration and new funding.
- Regulatory approval secured for TRP-8803 BED trial at Swinburne University
- First patient enrolled with dosing expected in December 2025
- Exclusive EEG-based brain entropy biomarker collaboration launched
- Key clinical appointments strengthen trial and formulation expertise
- $2.6 million non-dilutive R&D loan facility secured to accelerate development
Clinical Breakthrough in Binge Eating Disorder
Melbourne-based biotechnology company Tryptamine Therapeutics Limited (ASX, TYP) has taken a significant step forward in the treatment of Binge Eating Disorder (BED) with the commencement of the world’s first clinical trial of TRP-8803, an intravenous formulation of psilocin. Following regulatory approvals granted to Swinburne University, the company has successfully enrolled its first patient and is preparing for initial dosing in the coming weeks.
The trial will recruit 12 patients in two cohorts receiving mid-range and high-range doses of TRP-8803, administered twice with psychotherapy support. The primary focus is on safety and tolerability, while secondary objectives include assessing the drug’s impact on binge-eating episodes and related weight indicators over a 12-week period.
Innovating Precision Psychiatry with EEG Biomarkers
In a landmark collaboration, Tryptamine Therapeutics has partnered with Professors Robin Carhart-Harris and Pedro Mediano to develop a proprietary EEG-based brain entropy platform. This innovative biomarker aims to enable precision psychiatry by predicting and optimizing therapeutic outcomes in real time during TRP-8803 treatment. The platform leverages machine learning and closed-loop EEG monitoring to identify patients most likely to benefit and to fine-tune dosing for maximum efficacy.
This initiative represents a pioneering effort to establish regulatory-grade physiological markers in psychiatry, potentially transforming how psychedelic-assisted therapies are administered and monitored.
Strengthening Clinical Leadership and Financial Position
To support its ambitious clinical program, Tryptamine Therapeutics has appointed Professor David Castle, a leading psychiatrist with extensive experience in psychedelic therapies, as Consultant Medical Officer. Additionally, Professor Marcel Mozafari joins as Senior Formulation Scientist, bolstering the company’s technical and clinical capabilities.
Financially, the company secured a $2.6 million non-dilutive R&D loan facility from Rockford Equity Pty Ltd, enhancing its ability to accelerate ongoing and planned clinical trials. As of 30 September 2025, Tryptamine held approximately $3.94 million in cash and funding facilities, with expected R&D tax rebates further supporting its operations.
Looking Ahead
With patient recruitment underway and initial dosing anticipated by December, Tryptamine Therapeutics is poised to deliver early clinical data in the first quarter of 2026. The company’s integrated approach, combining innovative drug formulation, cutting-edge biomarker development, and strengthened clinical expertise, positions it at the forefront of psychedelic-assisted treatment innovation for eating disorders and related mental health conditions.
Bottom Line?
Tryptamine’s progress in clinical trials and biomarker technology could redefine treatment paradigms for BED and beyond.
Questions in the middle?
- How will early clinical trial results influence regulatory and commercial pathways for TRP-8803?
- What impact will the EEG-based biomarker platform have on patient selection and dosing precision?
- Can Tryptamine leverage its strengthened clinical team to expand TRP-8803 into additional mental health indications?
