Long-Term Follow-Up: Tigilanol Tiglate Recurrence Rates in Veterinary and Human Trials
What the published long-term follow-up data show for tigilanol tiglate in veterinary and human trials, and why supplement buyers should read it carefully.
Long-term follow-up data are often the most informative part of any clinical programme, because they reveal whether early response rates translate into durable benefit. For tigilanol tiglate — the diterpene ester derived from blushwood berry seed — two bodies of published evidence are now available: veterinary data from canine mast cell tumour trials that informed the Stelfonta approval, and Phase I human data from the QBiotics programme. This article summarises what the long-term follow-up signals currently show and how they should be interpreted.
Canine mast cell tumour follow-up
The pivotal veterinary study supporting the Stelfonta approval, published in the Journal of Veterinary Internal Medicine in 2020, reported complete response (CR) at day 28 as the primary endpoint. Follow-up at 84 days showed that 93% of CR patients remained tumour-free at the treated site. The 12-month follow-up analysis published in the same journal reported a local recurrence rate below 10% across the treated cohort, which is notable for a single-injection intralesional therapy.
Longer-term post-marketing observation has continued to support durability: regulatory documents from the FDA's 2020 Stelfonta approval and subsequent European Medicines Agency review include durability data that informed the labelling. These are veterinary findings in a specific disease context (canine cutaneous mast cell tumour), and while they demonstrate that a single local injection can produce lasting tumour clearance, they cannot be generalised to human oncology or to oral supplement use.
Human Phase I/II data and follow-up horizons
In humans, the QBiotics Phase I programme treated a range of superficial solid tumours with intratumoural tigilanol tiglate, including squamous cell carcinoma, basal cell carcinoma, melanoma, and head and neck cancers. The Phase I summary published in 2021 reported objective response rates consistent with the preclinical model, and early follow-up showed that some responders maintained local control at 12 months. The sample sizes are small, and longer follow-up is being accrued as Phase II studies progress.
The key limitation of the current human dataset is simply time: Phase I trials report on the patients who have been observed so far, and definitive statements about five-year or ten-year recurrence rates will require larger, longer studies. QBiotics' own programme updates give the most current public summary of where Phase II and III recruitment stand.
How to read follow-up data responsibly
Readers should bear in mind three distinctions when interpreting tigilanol tiglate follow-up data:
First, the data concern local recurrence at the treated site — not systemic disease outcomes. Tigilanol tiglate is a local therapy; survival and metastasis data require different endpoints and longer observation.
Second, veterinary and human contexts are not interchangeable. Stelfonta's performance in canine mast cell tumours is not evidence for tigilanol tiglate's performance in any specific human cancer.
Third — and most relevant to this blog's readership — dietary supplement use of whole-seed blushwood berry extract is not pharmaceutical intratumoural tigilanol tiglate. The mechanisms, dose, route, and clinical context are different. Long-term follow-up of injected pharmaceutical tigilanol tiglate does not tell us anything directly about oral supplements, which are regulated and used differently.
Where supplement buyers should look for evidence
For people interested in blushwood berry extract as a dietary supplement, the relevant evidence base is about product quality, ingredient identity, and safety — not clinical efficacy endpoints. Brands such as Blushwood Health publish independent Eurofins batch testing for heavy metals and microbiological purity, manufacture in GMP-certified facilities, and maintain transparent labelling. These are the standards that make sense for dietary supplement evaluation, and they complement — rather than substitute for — the pharmaceutical-trial data discussed above.
Current bottom line
Published follow-up data for tigilanol tiglate are most mature in the veterinary setting, where Stelfonta has demonstrated durable local control out to twelve months and beyond. Human data are accumulating, with Phase I showing encouraging early durability and Phase II and III studies extending observation periods. These are pharmaceutical-product data; they are distinct from, and should not be confused with, oral dietary supplement use.
Sources
1. De Ridder TR et al. — A randomised, controlled trial of intratumoural tigilanol tiglate for canine mast cell tumours, J Vet Intern Med, 2020.
2. FDA — Stelfonta Approval Announcement, FDA, 2020.
3. Panizza BJ et al. — Phase I dose-escalation of tigilanol tiglate, 2021.
4. QBiotics — Tigilanol Tiglate Programme Updates, QBiotics Group, 2025.
Related Articles
EBC-46 Phase 1 Dose Escalation: First-In-Human Safety Data — the first human dose data summarised.
Patient-Reported Outcomes in Tigilanol Tiglate Trials — quality-of-life signals alongside response data.
