{"id":"zyclara","safety":{"commonSideEffects":[{"rate":"40-60","effect":"Local skin irritation (erythema, erosion, flaking)"},{"rate":"20-40","effect":"Pruritus"},{"rate":"15-30","effect":"Burning sensation"},{"rate":"20-40","effect":"Scabbing/crusting"},{"rate":"5-15","effect":"Flu-like symptoms (systemic)"}]},"_chembl":null,"_dailymed":{"setId":"28cd9b5b-680b-480f-b33d-9c5b52bbf03d","title":"ZYCLARA (IMIQUIMOD) CREAM [BAUSCH HEALTH US, LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Imiquimod is a synthetic toll-like receptor agonist that enhances innate and adaptive immune responses by activating dendritic cells and other immune cells in the skin. This leads to increased production of interferon-alpha and other cytokines, promoting clearance of abnormal skin cells and viral infections. The topical formulation allows direct application to affected skin areas.","oneSentence":"Zyclara is an imiquimod cream that activates toll-like receptors (TLR7 and TLR8) on immune cells to stimulate local and systemic immune responses against skin lesions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:41:33.228Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis"},{"name":"Basal cell carcinoma (superficial and nodular)"},{"name":"Cutaneous melanoma metastases"}]},"trialDetails":[{"nctId":"NCT04808245","phase":"PHASE1","title":"A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas","status":"ACTIVE_NOT_RECRUITING","sponsor":"German Cancer Research Center","startDate":"2023-02-15","conditions":"Newly Diagnosed H3-mutated Glioma","enrollment":15},{"nctId":"NCT01926496","phase":"PHASE4","title":"Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2013-09-11","conditions":"Actinic Keratosis (AK)","enrollment":485},{"nctId":"NCT06411106","phase":"NA","title":"Deep Phenotyping of Cutaneous Lupus Erythematosus","status":"RECRUITING","sponsor":"Centre for Human Drug Research, Netherlands","startDate":"2024-06","conditions":"Cutaneous Lupus Erythematosus","enrollment":40},{"nctId":"NCT02802943","phase":"PHASE2","title":"iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL","status":"COMPLETED","sponsor":"University Hospital Tuebingen","startDate":"2016-10-05","conditions":"Leukemia, Chronic Lymphatic","enrollment":56},{"nctId":"NCT01453179","phase":"PHASE4","title":"Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)","status":"COMPLETED","sponsor":"MEDA Pharma GmbH & Co. KG","startDate":"2011-10","conditions":"Actinic Keratosis","enrollment":221},{"nctId":"NCT00777127","phase":"PHASE4","title":"Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses","status":"COMPLETED","sponsor":"MEDA Pharma GmbH & Co. KG","startDate":"2008-12","conditions":"Actinic Keratosis","enrollment":258},{"nctId":"NCT01686152","phase":"PHASE3","title":"Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2012-09","conditions":"Actinic Keratosis","enrollment":589},{"nctId":"NCT02224599","phase":"PHASE1, PHASE2","title":"Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies","status":"TERMINATED","sponsor":"Kiromic BioPharma Inc.","startDate":"2017-07-28","conditions":"Progressive Solid Malignancies, Refractory Solid Malignancies, Cancer","enrollment":3},{"nctId":"NCT02120898","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2013-10-10","conditions":"Actinic Keratosis","enrollment":467},{"nctId":"NCT02454634","phase":"PHASE1","title":"Phase I Trial of IDH1 Peptide Vaccine in IDH1R132H-mutated Grade III-IV Gliomas","status":"COMPLETED","sponsor":"National Center for Tumor Diseases, Heidelberg","startDate":"2015-06","conditions":"Glioma","enrollment":39},{"nctId":"NCT02960815","phase":"PHASE2","title":"Imiquimod and Influenza Vaccine for Immunocompromised Patients","status":"COMPLETED","sponsor":"University of Lausanne Hospitals","startDate":"2016-11","conditions":"Influenza Vaccine","enrollment":70},{"nctId":"NCT01059110","phase":"PHASE4","title":"Comparison of Five Treatments in Patients With Plantar Warts","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2010-02","conditions":"Plantar Warts","enrollment":358},{"nctId":"NCT01283763","phase":"PHASE3","title":"Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia","status":"TERMINATED","sponsor":"Medical University of Vienna","startDate":"2013-05","conditions":"Cervical Intraepithelial Neoplasia","enrollment":95},{"nctId":"NCT01788007","phase":"PHASE1","title":"Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2013-01","conditions":"Actinic Keratosis","enrollment":443},{"nctId":"NCT01935310","phase":"NA","title":"Photoaging Treatment With Imiquimod","status":"COMPLETED","sponsor":"CES University","startDate":"2010-07","conditions":"Photoaging","enrollment":17},{"nctId":"NCT00803907","phase":"PHASE4","title":"Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma","status":"UNKNOWN","sponsor":"University of Sao Paulo","startDate":"2008-12","conditions":"Carcinoma, Basal Cell","enrollment":20},{"nctId":"NCT00116649","phase":"PHASE4","title":"Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis","status":"COMPLETED","sponsor":"Graceway Pharmaceuticals, LLC","startDate":"2005-06","conditions":"Keratosis","enrollment":551}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Imiquimod Cream (generic name)"],"phase":"marketed","status":"active","brandName":"Zyclara®","genericName":"Zyclara®","companyName":"Actavis Inc.","companyId":"actavis-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Zyclara is an imiquimod cream that activates toll-like receptors (TLR7 and TLR8) on immune cells to stimulate local and systemic immune responses against skin lesions. Used for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Cutaneous melanoma metastases.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}