{"id":"ingenol-mebutate-reference","safety":{"commonSideEffects":[{"rate":"80–90","effect":"Application site erythema"},{"rate":"50–70","effect":"Application site pain"},{"rate":"40–60","effect":"Application site edema"},{"rate":"30–50","effect":"Application site erosion"},{"rate":"20–40","effect":"Application site pruritus"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ingenol mebutate activates protein kinase C, leading to direct cytotoxic effects on keratinocytes and induction of local inflammation. This triggers both rapid necrosis of treated lesions and a delayed immune response that eliminates residual dysplastic cells in the surrounding skin, providing both immediate and sustained therapeutic benefit.","oneSentence":"Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of treated cells and promotes immune-mediated clearance of actinic keratosis lesions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:48:29.038Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (field treatment on face or scalp)"}]},"trialDetails":[{"nctId":"NCT02459795","phase":"PHASE3","title":"To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Padagis LLC","startDate":"2015-05","conditions":"Actinic Keratosis","enrollment":469},{"nctId":"NCT02385318","phase":"PHASE3","title":"To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Padagis LLC","startDate":"2015-02","conditions":"Actinic Keratosis","enrollment":519},{"nctId":"NCT02654769","phase":"PHASE3","title":"A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2015-02","conditions":"Actinic Keratosis","enrollment":441},{"nctId":"NCT03200912","phase":"PHASE3","title":"An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2016-08-19","conditions":"ACTINIC KERATOSIS","enrollment":507}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Reference Listed Drug Product"],"phase":"phase_3","status":"active","brandName":"Ingenol Mebutate (Reference)","genericName":"Ingenol Mebutate (Reference)","companyName":"Padagis LLC","companyId":"padagis-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of treated cells and promotes immune-mediated clearance of actinic keratosis lesions. Used for Actinic keratosis (field treatment on face or scalp).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}