{"entity":{"id":"tigilanol-tiglate","kind":"drug","name":"Tigilanol tiglate","aka":["Stelfonta","EBC-46","tigilanol tiglate injection"],"tldr":"Tigilanol tiglate (Stelfonta) is an injection into the tumour, approved by the US Food and Drug Administration in 2020 to treat mast cell tumours in dogs. In people it is still experimental and is being tested in sarcoma and head and neck cancer.","summary":"Stelfonta (tigilanol tiglate injection) was approved by the FDA Center for Veterinary Medicine on 16 November 2020 under NADA 141-541, sponsored by QBiotics Group Ltd, for use in dogs for the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock. The FDA described it as the first approval of an intratumoral injection for non-metastatic mast cell tumours in dogs. It must be given with a corticosteroid and H1 and H2 receptor blockers to reduce the risk of systemic reactions from mast cell degranulation.\n\nIn the field study, 60 of 80 treated dogs (75%) had a complete response at day 28, against 2 of 38 untreated controls (5.3%); 8 of 18 dogs retreated at day 30 had a complete response four weeks later. In people, QBiotics is running phase 2 trials of intratumoural tigilanol tiglate in soft tissue sarcoma (NCT05755113) and head and neck cancer (NCT05608876); two melanoma trials (NCT04834973 with pembrolizumab, NCT05234437) were terminated.","status":"phase-2","asOf":"2026-11-04","links":[{"label":"FDA Consumer Update: My Dog Has Cancer: What Do I Need to Know?","url":"https://www.fda.gov/consumers/consumer-updates/my-dog-has-cancer-what-do-i-need-know"},{"label":"FDA Freedom of Information Summary, NADA 141-541 Stelfonta (approved 16 November 2020)","url":"https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/9988"},{"label":"FDA CVM update, 16 November 2020: first intratumoral injection for non-metastatic mast cell tumours in dogs","url":"https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-intratumoral-injection-treat-non-metastatic-mast-cell-tumors-dogs"},{"label":"ClinicalTrials.gov NCT05755113 (soft tissue sarcoma, phase 2)","url":"https://clinicaltrials.gov/study/NCT05755113"},{"label":"ClinicalTrials.gov NCT05608876 (head and neck cancer, phase 2)","url":"https://clinicaltrials.gov/study/NCT05608876"}],"tags":["veterinary","comparative-oncology"],"related":["idea-bio1-comparative-oncology-dogs","veterinary-and-comparative-oncology"],"cancers":[],"sections":[],"technologies":[],"targets":["pkc"],"drugs":[],"companies":["qbiotics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05755113","nct05608876"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Stelfonta","modality":"small molecule (intratumoural injection)","mechanism":"Injected into the tumour, it lyses cells and activates a protein kinase C (PKC) cascade that spreads through the treated tumour, causing an acute inflammatory response and increased permeability of the tumour blood vessels that leads to their destruction; the FDA summary notes it does not specifically target cancer cells.","approvals":[],"mechanismSteps":["The drug is injected directly into the tumour","It breaks open cells and switches on protein kinase C, setting off a strong local inflammation","The tumour's blood vessels leak and are destroyed","The tumour dies and leaves a wound that heals over the following weeks"],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tigilanol-tiglate/","neighbours":{"idea":[{"id":"idea-bio1-comparative-oncology-dogs","kind":"idea","name":"Pet dogs with spontaneous cancer as a bridge before human trials","route":"/ideas/idea-bio1-comparative-oncology-dogs/"}],"journal":[{"id":"veterinary-and-comparative-oncology","kind":"journal","name":"Veterinary and comparative oncology","route":"/journals/veterinary-and-comparative-oncology/"}],"target":[{"id":"pkc","kind":"target","name":"Protein kinase C family (PKC)","route":"/targets/pkc/"}],"company":[{"id":"qbiotics","kind":"company","name":"QBiotics","route":"/companies/qbiotics/"}],"trial":[{"id":"nct05755113","kind":"trial","name":"A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma","route":"/trials/nct05755113/"},{"id":"nct05608876","kind":"trial","name":"A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer","route":"/trials/nct05608876/"}]}}