{"id":"leo-80185-gel","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site burning or stinging"},{"rate":null,"effect":"Skin irritation"},{"rate":null,"effect":"Pruritus"}]},"_chembl":{"chemblId":"CHEMBL3545074","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug works by inhibiting calcineurin, a phosphatase enzyme critical for T-cell activation and cytokine production. By blocking this pathway in dermal tissue, it reduces inflammatory responses and immune-mediated skin damage. This mechanism makes it suitable for treating inflammatory skin conditions where local immunosuppression is beneficial.","oneSentence":"LEO 80185 is a topical calcineurin inhibitor that suppresses local immune responses in the skin.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:35.173Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis"},{"name":"Eczema"}]},"trialDetails":[{"nctId":"NCT01120223","phase":"PHASE2","title":"Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2010-05","conditions":"Scalp Psoriasis","enrollment":78},{"nctId":"NCT01083758","phase":"PHASE2","title":"Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2010-04","conditions":"Scalp Psoriasis","enrollment":31},{"nctId":"NCT02038569","phase":"PHASE2","title":"An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2014-01","conditions":"Psoriasis Vulgaris","enrollment":125},{"nctId":"NCT00670241","phase":"PHASE3","title":"Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2008-04","conditions":"Psoriasis Vulgaris","enrollment":458},{"nctId":"NCT02668692","phase":"PHASE3","title":"LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2016-02","conditions":"Psoriasis Vulgaris","enrollment":213},{"nctId":"NCT00216879","phase":"PHASE3","title":"Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2005-02","conditions":"Psoriasis of Scalp","enrollment":800},{"nctId":"NCT01229098","phase":"PHASE2","title":"Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2010-10","conditions":"Psoriasis Vulgaris","enrollment":102},{"nctId":"NCT00263718","phase":"PHASE2","title":"Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2005-12","conditions":"Psoriasis Vulgaris","enrollment":360},{"nctId":"NCT02605057","phase":"PHASE1","title":"Dermatopharmacokinetic Trial of LEO 80185 Gel","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-11","conditions":"Psoriasis Vulgaris","enrollment":32},{"nctId":"NCT02379793","phase":"PHASE1","title":"Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-03","conditions":"Skin and Connective Tissue Diseases","enrollment":33}],"_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":"LEO 80185 gel","genericName":"LEO 80185 gel","companyName":"LEO Pharma","companyId":"leo-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LEO 80185 is a topical calcineurin inhibitor that suppresses local immune responses in the skin. Used for Atopic dermatitis, Eczema.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}