{"id":"elidel-pimecrolimus-cream","safety":{"commonSideEffects":[{"rate":"26-40","effect":"Application site burning/irritation"},{"rate":"7-10","effect":"Headache"},{"rate":"5-8","effect":"Nasopharyngitis"},{"rate":"3-5","effect":"Skin infection"},{"rate":"2-4","effect":"Pruritus"}]},"_chembl":{"chemblId":"CHEMBL1200686","moleculeType":"Small molecule","molecularWeight":"810.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pimecrolimus binds to macrophilin-12 and inhibits calcineurin, a phosphatase required for T-cell receptor signaling and transcription factor activation. This prevents the release of pro-inflammatory cytokines (IL-2, TNF-α, IFN-γ) from T cells and mast cells, reducing skin inflammation. Unlike topical corticosteroids, it does not cause skin atrophy and is suitable for use on sensitive areas including the face.","oneSentence":"Pimecrolimus is a calcineurin inhibitor that suppresses T-cell activation and inflammatory cytokine production in the skin.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:40.813Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis (eczema) in patients ≥2 years of age"},{"name":"Short-term and intermittent long-term treatment of mild to moderate atopic dermatitis"}]},"trialDetails":[{"nctId":"NCT01037881","phase":"PHASE2","title":"LEO 29102 Cream in the Treatment of Atopic Dermatitis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2009-12","conditions":"Atopic Dermatitis","enrollment":183},{"nctId":"NCT06052995","phase":"","title":"Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.","status":"UNKNOWN","sponsor":"MEDA PHARMA SPA, a Viatris company","startDate":"2023-11","conditions":"Mild to Moderate Atopic Dermatitis","enrollment":130},{"nctId":"NCT04976868","phase":"","title":"Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2021-03-18","conditions":"Atopic Dermatitis","enrollment":130},{"nctId":"NCT03107611","phase":"PHASE3","title":"Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2016-02-29","conditions":"Atopic Dermatitis","enrollment":654},{"nctId":"NCT02791308","phase":"PHASE3","title":"Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2015-02","conditions":"Atopic Dermatitis","enrollment":587},{"nctId":"NCT02896101","phase":"PHASE3","title":"Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Glenmark Pharmaceuticals Ltd. India","startDate":"2016-08","conditions":"Atopic Dermatitis","enrollment":755},{"nctId":"NCT00222183","phase":"NA","title":"Cutaneous Lupus Erythematosus and Elidel","status":"WITHDRAWN","sponsor":"University of Leipzig","startDate":"2003-06","conditions":"Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid","enrollment":""},{"nctId":"NCT03297502","phase":"PHASE3","title":"Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2016-06","conditions":"Atopic Dermatitis","enrollment":582},{"nctId":"NCT00655512","phase":"PHASE1","title":"Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound","status":"COMPLETED","sponsor":"Technische Universität Dresden","startDate":"2008-01","conditions":"Healthy","enrollment":40},{"nctId":"NCT00393263","phase":"PHASE2","title":"Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus","status":"COMPLETED","sponsor":"Center for Vulvovaginal Disorders","startDate":"2006-10","conditions":"Lichen Sclerosus","enrollment":38},{"nctId":"NCT01202149","phase":"PHASE4","title":"Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis","status":"COMPLETED","sponsor":"Frankel, Amylynne, M.D.","startDate":"2010-03","conditions":"Eczema, Atopic Dermatitis","enrollment":30},{"nctId":"NCT00124709","phase":"PHASE4","title":"Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-10","conditions":"Atopic Dermatitis","enrollment":1091},{"nctId":"NCT01177566","phase":"PHASE4","title":"Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.","status":"COMPLETED","sponsor":"Emer, Jason, M.D.","startDate":"2009-09","conditions":"Atopic Dermatitis","enrollment":20}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":250,"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":"Elidel® (pimecrolimus) Cream","genericName":"Elidel® (pimecrolimus) Cream","companyName":"Glenmark Pharmaceuticals Ltd. India","companyId":"glenmark-pharmaceuticals-ltd-india","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pimecrolimus is a calcineurin inhibitor that suppresses T-cell activation and inflammatory cytokine production in the skin. Used for Atopic dermatitis (eczema) in patients ≥2 years of age, Short-term and intermittent long-term treatment of mild to moderate atopic dermatitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}