{"id":"oleogel-s10","safety":{"commonSideEffects":[{"rate":null,"effect":"Local skin irritation"},{"rate":null,"effect":"Allergic contact dermatitis"},{"rate":null,"effect":"Application site reactions"}]},"_chembl":{"chemblId":"CHEMBL3983878","moleculeType":"Small molecule","molecularWeight":"452.00"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Oleogel-S10 combines an oil-based gel vehicle with standardized birch bark extract (betulin and related compounds), which exerts anti-inflammatory effects and supports the natural wound healing process. The formulation is designed to create an optimal microenvironment for epithelialization and tissue regeneration while protecting the wound from external contamination.","oneSentence":"Oleogel-S10 is a topical oleogel formulation containing birch bark extract that promotes wound healing and tissue repair through anti-inflammatory and antimicrobial properties.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:47:13.860Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute wounds (cuts, abrasions, minor surgical wounds)"},{"name":"Chronic wounds and ulcers"}]},"trialDetails":[{"nctId":"NCT06917690","phase":"PHASE3","title":"A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa","status":"RECRUITING","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2025-04-18","conditions":"Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic","enrollment":6},{"nctId":"NCT05190770","phase":"PHASE2","title":"A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2021-12-15","conditions":"Breast Cancer, Breast Cancer Stage, Breast Cancer Stage I","enrollment":18},{"nctId":"NCT03068780","phase":"PHASE3","title":"Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa","status":"COMPLETED","sponsor":"Amryt Research Limited","startDate":"2017-03-29","conditions":"Epidermolysis Bullosa","enrollment":223},{"nctId":"NCT01807650","phase":"PHASE3","title":"Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)","status":"COMPLETED","sponsor":"Birken AG","startDate":"2013-03","conditions":"Wounds","enrollment":112},{"nctId":"NCT01294241","phase":"PHASE2","title":"Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)","status":"COMPLETED","sponsor":"Birken AG","startDate":"2010-11","conditions":"Inherited Epidermolysis Bullosa","enrollment":10},{"nctId":"NCT01657305","phase":"PHASE3","title":"Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)","status":"COMPLETED","sponsor":"Birken AG","startDate":"2012-08","conditions":"Wounds","enrollment":107},{"nctId":"NCT01657292","phase":"PHASE3","title":"Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds","status":"COMPLETED","sponsor":"Birken AG","startDate":"2012-08","conditions":"Burns","enrollment":61},{"nctId":"NCT00786994","phase":"PHASE2","title":"The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses","status":"COMPLETED","sponsor":"Birken AG","startDate":"2008-10","conditions":"Actinic Keratoses","enrollment":165},{"nctId":"NCT01294254","phase":"PHASE2","title":"Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites","status":"COMPLETED","sponsor":"Birken AG","startDate":"2010-04","conditions":"Accelerating the Epithelialization of Split Thickness Skin Graft","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":20,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Sericare®","Episalvan","Filsuvez"],"phase":"phase_3","status":"active","brandName":"Oleogel-S10","genericName":"Oleogel-S10","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Oleogel-S10 is a topical oleogel formulation containing birch bark extract that promotes wound healing and tissue repair through anti-inflammatory and antimicrobial properties. Used for Acute wounds (cuts, abrasions, minor surgical wounds), Chronic wounds and ulcers.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}