EBC-46

EBC-46 (Tigilanol Tiglate): The Complete Scientific Guide

The definitive reference on EBC-46 (tigilanol tiglate): its chemistry, mechanism of action, veterinary approval as Stelfonta®, ongoing human Phase I/II trials, Blushwood berry source, and what current science says for patients and supplement users.

Marcus Webb

Marcus Webb

— 2 min read
EBC-46 (Tigilanol Tiglate): The Complete Scientific Guide

What Is EBC-46?

EBC-46 — scientifically known as tigilanol tiglate — is a small-molecule compound first isolated from the seeds of the Blushwood tree (Fontainea picrosperma), a rainforest plant native to the Wet Tropics of Far North Queensland, Australia.[1]

Discovered and developed by QBiotics Group in partnership with QIMR Berghofer Medical Research Institute, EBC-46 has become one of the most studied naturally derived anti-cancer compounds of the past decade.

Regulatory Approvals

EBC-46 achieved a landmark regulatory milestone in 2020 when the United States FDA approved Stelfonta® (tigilanol tiglate injection) — the first drug specifically approved for direct intratumoral treatment of non-metastatic canine mast cell tumours.[2]

The European Medicines Agency (EMA) granted equivalent marketing authorisation, confirming Stelfonta's safety and efficacy profile across two major regulatory jurisdictions.[3]

For human applications, EBC-46 holds FDA Orphan Drug Designation for multiple cancer indications — a status that accelerates the development pathway and signals serious regulatory interest.[4]

How Does EBC-46 Work?

EBC-46 is a potent activator of protein kinase C (PKC), triggering a cascade of intracellular events that ultimately destroys tumour tissue through three distinct mechanisms:

  • Direct tumour cell destruction via rapid vascular disruption within the tumour
  • Stimulation of an acute immune response that attacks residual cancer cells
  • Induction of innate immune memory, helping prevent tumour recurrence

Clinical Research Progress

A landmark 2014 study published in PLOS ONE documented complete tumour resolution in equine sarcoids following intratumoral EBC-46 injection, with no systemic toxicity reported.[5]

Phase I human clinical trials are now underway. ClinicalTrials.gov lists active and completed studies across head and neck squamous cell carcinoma (HNSCC), cutaneous tumours, and other solid tumour types.

Blushwood tree fruit in Australian rainforest — natural source of tigilanol tiglate EBC-46
The Blushwood tree (Fontainea picrosperma) grows exclusively in the rainforests of Far North Queensland, Australia.

EBC-46 vs. Conventional Treatments

Traditional chemotherapy and radiation attack both cancerous and healthy cells, often causing debilitating side effects. EBC-46 works differently — it is delivered directly into the tumour, minimising systemic exposure and collateral tissue damage.

Key Takeaways

  • EBC-46 (tigilanol tiglate) is a naturally occurring compound from the Australian Blushwood berry
  • FDA and EMA approved as Stelfonta® for canine cancer (2020)
  • Active Phase I/II human clinical trials ongoing
  • Mechanism: PKC activation → vascular disruption → immune activation
  • Orphan Drug Designation for multiple human cancer indications

References

  1. Boyle GM et al. (2014). Intralesional injection of the novel PKC activator EBC-46 rapidly ablates tumors in mouse models. PLOS ONE. View source ↗
  2. U.S. FDA (2020). FDA Approves First Drug for Direct Treatment of Non-Metastatic Canine Mast Cell Tumors. View source ↗
  3. European Medicines Agency (2020). Stelfonta EPAR. View source ↗
  4. U.S. FDA. Orphan Drug Designations and Approvals. View source ↗
  5. QIMR Berghofer Medical Research Institute. Translational Research Programs. View source ↗
  6. ClinicalTrials.gov. Tigilanol tiglate clinical studies. View source ↗

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