Drugs / Tigilanol Tiglate
Tigilanol Tiglate
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04834973 | May 2021 → Jul 2022 | melanoma | QBiotics Group Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT05755113 | Apr 2023 → Jan 2027 expected | soft tissue sarcoma | QBiotics Group Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT05608876 | Nov 2022 → Jul 2025 overdue | head and neck cancer | QBiotics Group Limited | Active not recruiting | Met primary |
| Phase 2 | NCT05234437 | Mar → Jul 2022 | melanoma | QBiotics Group Limited | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-08-03 | QBiotics Group Limited | Results QBiotics reports 78% overall response rate in injected tumours treated with tigilanol tiglate in a Phase II head and neck cancer clinical trial qbiotics.com ↗
QBiotics Group Limited ( QBiotics ) is pleased to announce positive final efficacy and safety results from its Phase II QB46C-H08 trial, with tigilanol tiglate achieving a 78% Objective Response Rate (ORR) in injected tumours in patients with head and neck solid malignancies who were refractory to standard of care. |
| 2025-02-17 | QBiotics Group Limited | Results QBiotics data presented at Society of Surgical Oncology Advanced Cancer Therapies 2025 Annual Meeting qbiotics.com ↗
QBiotics Group Limited ( QBiotics ) is pleased to share a poster presentation providing data on new pharmacokinetic findings from its Phase IIa clinical trial in Soft Tissue Sarcoma. |
| 2025-02-05 | QBiotics Group Limited | Regulatory QBiotics’ veterinary drug, STELFONTA ® label extended, enabling more dogs to receive cancer treatment without surgery in Great Britain qbiotics.com ↗
The UK Veterinary Medicines Directorate (VMD) approves extended use of QBiotics’ oncology veterinary pharmaceutical, STELFONTA ® (tigilanol tiglate). |
| 2024-11-19 | QBiotics Group Limited | Results QBiotics Phase IIa Soft Tissue Sarcoma trial extended, following positive data presented at CTOS qbiotics.com ↗
CTOS presentation includes additional observations made by the investigators showing that patients with metastatic STS disease who were originally non-responsive to systemic therapies began to respond to systemic therapy after treatment with TT. |
| 2024-09-17 | QBiotics Group Limited | Results Preliminary data from QBiotics’ Phase IIa clinical trial in Soft Tissue Sarcoma presented at ESMO Congress 2024 qbiotics.com ↗
Preliminary data highlighted in the poster indicates that TT appears safe for patients with STS, with early signs of efficacy. |
| 2024-05-03 | QBiotics Group Limited | Results Tigilanol tiglate preclinical data published in Journal for ImmunoTherapy of Cancer qbiotics.com ↗
The results confirm that tigilanol tiglate acts via multiple pathways to promote tumour ablation and may also effectively control disease burden in the right tumour (immunogenic) and patient contexts. |
| 2024-02-16 | QBiotics Group Limited | Regulatory QBiotics drug tigilanol tiglate awarded Orphan Drug Designation for patients with soft tissue sarcoma qbiotics.com ↗
QBiotics Group Limited ( QBiotics ) is pleased to announce that its lead intratumoural oncology asset, tigilanol tiglate, has been awarded Orphan Drug Designation for the treatment of soft tissue sarcoma by the United States Food and Drug Administration (FDA). |
| 2023-10-16 | QBiotics Group Limited | Results New STELFONTA ® data presented at the 2023 Veterinary Cancer Society Annual Conference qbiotics.com ↗
Biopsy within 5-10 minutes post-tigilanol tiglate provides viable tissue samples for histopathological and genomic diagnostics without compromising treatment efficacy. |
| 2023-08-16 | QBiotics Group Limited | Results QBiotics’ tigilanol tiglate meets Primary Endpoints in its Phase I/IIa head and neck cancer dose escalation trial qbiotics.com ↗
QBiotics reports that Primary Endpoint of safety and tolerability were met in its Human Clinical Phase I/IIa dose escalation safety trial of tigilanol tiglate conducted as a window of opportunity before surgery study in 19 patients with head and neck squamous cell carcinoma (QB46C-H03). |
| 2022-12-22 | QBiotics Group Limited | Results QBiotics Poster Presentation at SITC 2022 qbiotics.com ↗
A Poster presentation shows that QBiotics lead oncology molecule tigilanol tiglate directly destroys injected tumours, as well as induces systemic immunity and has the potential to induce responses in non-injected tumours. |
| 2022-12-11 | QBiotics Group Limited | Regulatory Update of QBiotics Group human oncology clinical trials qbiotics.com ↗
QBiotics has received Clinical Trial Authorisation (CTA) from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). |
| 2022-07-25 | QBiotics Group Limited | Regulatory US FDA approves QBiotics investigational new drug application to initiate tigilanol tiglate soft tissue sarcoma Phase II trial qbiotics.com ↗
QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule oncology and wound healing pharmaceuticals, has been granted approval of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for lead oncology molecule, tigilanol tiglate. |
| 2021-07-07 | QBiotics Group Limited | Regulatory New cancer treatment for Australian dogs with APVMA approval of QBiotics’ STELFONTA ® qbiotics.com ↗
QBiotics Group Limited (QBiotics), an Australian life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, is pleased to announce the Australian Pesticides and Veterinary Medicines Authority (APVMA) has approved* its lead veterinary product STELFONTA ® (tigilanol tiglate). |
| 2020-11-17 | QBiotics Group Limited | Regulatory FDA approves registration of STELFONTA ® qbiotics.com ↗ |
| 2020-04-27 | QBiotics Group Limited | Regulatory QBiotics commercialises first tigilanol tiglate pharmaceutical product with launch of STELFONTA ® qbiotics.com ↗
STELFONTA ® (tigilanol tiglate) is now available as the first pharmaceutical treatment for all grades of canine non-metastatic mast cell tumours (MCT). |
| 2020-01-20 | QBiotics Group Limited | Regulatory QBiotics receives first registration for tigilanol tiglate with European Medicines Agency approval of STELFONTA ® qbiotics.com ↗
STELFONTA ® (tigilanol tiglate) has been approved by the European Medicines Agency (EMA), making it the first pharmaceutical treatment available for all grades of canine non-metastatic mast cell tumours (MCT). |
| 2019-12-10 | QBiotics Group Limited | Results The first in-human Clinical Phase I study of intratumoural tigilanol tiglate has been published in The Lancet's EBioMedicine journal qbiotics.com ↗
Promising outcomes were attained in patients with a variety of solid tumour types, with a 27% treatment response, including 18% complete response (full tumour destruction). |
| 2019-04-11 | QBiotics Group Limited | Results International Publication - Tigilanol Tiglate Canine Dose Characterisation Study qbiotics.com ↗
This dose characterization study identified that tigilanol tiglate at a concentration of 1 mg/mL dosed at 0.5mL per cm3 of tumor volume (50% v/v tumor), is highly efficacious for the treatment of MCT in dogs. |
All press releases naming this drug 28 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tigilanol tiglate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05234437 ↗ |
| Known as | EBC-46 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989916 ↗ |
| Known as | EBI-46 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989916 ↗ |
| Known as | Stelfonta | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989916 ↗ |
| Known as | Tiglate de tigilanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989916 ↗ |
| Known as | Toglato de tigilanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989916 ↗ |
| Modality | Small molecule | “Tigilanol tiglate is a novel, short-chain diterpene ester in early clinical development for local treatment of a wide range of solid tumours.” NCT04834973 ↗ |
| Route | Other | “Single or multiple Intratumoural treatment of tigilanol tiglate at escalating doses of 0.6 mg/m2, 1.2 mg/m2 and 2.4 mg/m2.” NCT04834973 ↗ |