{"id":"cls001-omiganan","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site reactions (erythema, irritation)"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Contact dermatitis"}]},"_chembl":{"chemblId":"CHEMBL1615933","moleculeType":"Protein","molecularWeight":"1779.18"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Omiganan is a synthetic 12-amino acid cationic antimicrobial peptide derived from indolicidin. It exerts its bactericidal effect by interacting with negatively charged components of bacterial cell membranes, causing membrane disruption and leakage of intracellular contents. This mechanism is distinct from conventional antibiotics and may help overcome resistance mechanisms.","oneSentence":"Omiganan is an antimicrobial peptide that disrupts bacterial cell membranes by binding to lipopolysaccharides and lipoteichoic acids, leading to bacterial cell death.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:05.721Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis with bacterial colonization"},{"name":"Impetigo and other skin and soft tissue infections"}]},"trialDetails":[{"nctId":"NCT02547441","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2015-12","conditions":"Rosacea","enrollment":463},{"nctId":"NCT02576860","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2015-10","conditions":"Rosacea","enrollment":263},{"nctId":"NCT02596074","phase":"PHASE2","title":"Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2015-11","conditions":"Usual Type Vulval Intraepithelial Neoplasia (uVIN)","enrollment":12},{"nctId":"NCT02849262","phase":"PHASE2","title":"Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2016-07","conditions":"Condylomata Acuminata (External)","enrollment":24},{"nctId":"NCT02571998","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2015-10","conditions":"Acne Vulgaris","enrollment":320},{"nctId":"NCT02456480","phase":"PHASE2","title":"Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2015-05","conditions":"Atopic Dermatitis","enrollment":37},{"nctId":"NCT01784133","phase":"PHASE2","title":"A Twelve Week Safety and Efficacy Study in Rosacea","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2013-03","conditions":"Papulopustular Rosacea","enrollment":240}],"_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":[],"phase":"phase_3","status":"active","brandName":"CLS001 (Omiganan)","genericName":"CLS001 (Omiganan)","companyName":"Maruho Co., Ltd.","companyId":"maruho-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omiganan is an antimicrobial peptide that disrupts bacterial cell membranes by binding to lipopolysaccharides and lipoteichoic acids, leading to bacterial cell death. Used for Atopic dermatitis with bacterial colonization, Impetigo and other skin and soft tissue infections.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}