{"id":"generic-ingenol-mebutate","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site erythema"},{"rate":null,"effect":"Application site pain"},{"rate":null,"effect":"Application site pruritus"},{"rate":null,"effect":"Application site edema"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ingenol mebutate activates protein kinase C (PKC), leading to direct cytotoxic effects on actinic keratosis cells through necrosis. Additionally, it triggers an immune response that eliminates residual diseased cells in the treated area. This dual mechanism—direct cell death plus immune activation—makes it effective for topical treatment of actinic keratosis.","oneSentence":"Ingenol mebutate is a protein kinase C activator that induces rapid necrosis of treated cells and promotes immune-mediated destruction of remaining lesions.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:47:20.223Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis"}]},"trialDetails":[{"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":49,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Test"],"phase":"phase_3","status":"active","brandName":"Generic Ingenol Mebutate","genericName":"Generic Ingenol Mebutate","companyName":"Actavis Inc.","companyId":"actavis-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ingenol mebutate is a protein kinase C activator that induces rapid necrosis of treated cells and promotes immune-mediated destruction of remaining lesions. Used for Actinic keratosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":7,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}