EBC-46 Human Trials Update: Phase I Safety Data and Phase II Progress in 2026
An evidence-based review of tigilanol tiglate human clinical trials, covering Phase I safety results and the expanding Phase II programme across multiple tumour types.
Clinical investigation of tigilanol tiglate in humans continues to generate data, building on the veterinary evidence base established through the Stelfonta approval process. As of early 2026, Phase I safety data is available and Phase II programmes are advancing, offering an increasingly detailed picture of the compound's clinical profile.
Phase I: Establishing Safety Parameters
The first-in-human Phase I trial of tigilanol tiglate, conducted by QBiotics Group, was designed as a dose-escalation study in patients with advanced solid tumours. The primary endpoints were safety, tolerability, and determination of a maximum tolerated dose (MTD). Intratumoural injection was the route of administration, consistent with the veterinary formulation.
Published results indicated that tigilanol tiglate was generally well tolerated at therapeutic doses. The most commonly reported adverse events were localised — injection site pain, erythema, and oedema — consistent with the compound's known mechanism of inducing localised haemorrhagic necrosis. Systemic adverse events were less frequent and generally mild, supporting the localised nature of the drug's activity.
Tumour Response Observations
While Phase I trials are designed primarily for safety rather than efficacy, the QBiotics programme reported notable tumour responses in a subset of patients. Complete responses — defined as complete disappearance of the treated lesion — were observed in several cases, particularly in cutaneous and subcutaneous tumour types. These observations, documented in conference presentations at American Association for Cancer Research (AACR) meetings, provided the rationale for expanded Phase II investigation.
Patient selection appears to be a critical factor in clinical outcomes. The most robust responses have been observed in accessible, superficial lesions where intratumoural injection can achieve adequate drug distribution throughout the tumour volume. Deep-seated or highly vascularised tumours present greater challenges for localised delivery.
Phase II: Current Status
Phase II trials are investigating tigilanol tiglate across multiple tumour types, with particular focus on melanoma, squamous cell carcinoma, and other cutaneous malignancies. These trials are evaluating both single-treatment and repeated-dosing protocols, seeking to establish optimal treatment regimens.
The ClinicalTrials.gov registry lists active and completed studies under the QBiotics programme. Enrollment criteria, study sites, and preliminary results are publicly accessible for researchers and interested patients.
Relevance to Supplement Consumers
It is important to note that all human clinical data to date involves injectable pharmaceutical-grade tigilanol tiglate, not oral blushwood berry extract supplements. The clinical trial programme is pursuing a drug development pathway distinct from the dietary supplement category. Consumers interested in blushwood berry extract supplements should understand that these are marketed under DSHEA as botanical dietary supplements, and are not intended to diagnose, treat, cure, or prevent any disease. Reputable suppliers like Blushwood Health are transparent about this distinction.
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For background on the science, see our article on the complete guide to EBC-46 and Fontainea picrosperma as the source of EBC-46.
