EBC-46 Human Trials: Phase I/II Data, Patient Selection, and Dose-Response
An overview of QBiotics' Phase I and II human trials of tigilanol tiglate — safety profile, dose escalation, patient selection, and what the data means for the supplement category.
Clinical investigation of tigilanol tiglate in humans has proceeded through a structured trial programme led by QBiotics Group. The data emerging from these trials provide important context for understanding how EBC-46 performs under rigorously controlled conditions — and for interpreting the supplement category appropriately.
Phase I: Safety and Dose Escalation
The Phase I programme for tigilanol tiglate in human subjects focused on establishing a safety profile and identifying the maximum tolerated dose for intratumoral injection. Participants with accessible solid tumours — including squamous cell carcinoma of the head and neck — received escalating doses under close monitoring.
Results indicated that intralesional tigilanol tiglate was well tolerated at therapeutic doses, with local reactions at the injection site being the predominant adverse event. Systemic toxicity was limited. Objective responses — including complete tumour regression in some participants — were observed, providing early proof-of-concept for human applications.
Phase II: Expanded Patient Selection
Phase II trials expanded the patient population and refined dosing protocols. QBiotics has reported responses in multiple solid tumour types accessible to direct injection. The trials have contributed to understanding patient selection criteria, including tumour size, depth, and accessibility as determinants of response.
A key refinement has been characterising the dose-response relationship: the volume of tigilanol tiglate required scales with tumour volume, with precision dosing critical to achieving complete necrosis while limiting spread to surrounding healthy tissue.
What Trial Data Means for the Supplement Category
It is important to note that human trial data relates exclusively to pharmaceutical-grade tigilanol tiglate administered by intratumoral injection — the same route used in the veterinary product Stelfonta. These trials do not evaluate oral blushwood berry extract supplements. DSHEA dietary supplements are not required to complete clinical trials, and the absence of oral human trial data does not reflect negatively on the supplement category — it simply reflects different regulatory pathways.
Buyers of oral supplements like those offered by Blushwood Health should consult a qualified healthcare professional to understand what the available evidence does and does not support.
References
1. QBiotics Group — Clinical Trials Overview, Phase I/II data summary.
2. ClinicalTrials.gov — Registry of registered tigilanol tiglate human studies.
3. FDA — Clinical Research Process, Phase I–III explained.
Related Articles
See: Complete Guide to EBC-46 and Tigilanol Tiglate and EBC-46 Regulatory Landscape 2026.
