{"id":"delgocitinib-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site reactions (erythema, irritation)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nasopharyngitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Delgocitinib selectively inhibits Janus kinase (JAK) enzymes, which are intracellular signaling proteins that mediate the effects of inflammatory cytokines like IL-4, IL-13, and IFN-γ. By blocking JAK signaling in T cells and other immune cells in the skin, it reduces the production of inflammatory mediators and dampens the aberrant immune response characteristic of atopic dermatitis. This leads to decreased inflammation, pruritus, and skin barrier dysfunction.","oneSentence":"Delgocitinib is a JAK inhibitor that suppresses inflammatory cytokine signaling in immune cells to reduce skin inflammation and itching in atopic dermatitis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:58.128Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis (topical cream formulation)"}]},"trialDetails":[{"nctId":"NCT07487948","phase":"PHASE2","title":"Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris","status":"NOT_YET_RECRUITING","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2026-05-04","conditions":"Central Centrifugal Cicatricial Alopecia, Lichen Planopilaris","enrollment":30},{"nctId":"NCT07013201","phase":"PHASE2","title":"A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis","status":"RECRUITING","sponsor":"LEO Pharma","startDate":"2025-09-11","conditions":"Palmoplantar Pustulosis","enrollment":135},{"nctId":"NCT07335588","phase":"PHASE3","title":"A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus","status":"NOT_YET_RECRUITING","sponsor":"LEO Pharma","startDate":"2026-05-06","conditions":"Lichen Sclerosus","enrollment":652},{"nctId":"NCT07203274","phase":"NA","title":"The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch","status":"NOT_YET_RECRUITING","sponsor":"Aalborg University","startDate":"2025-12-01","conditions":"Itchiness","enrollment":30},{"nctId":"NCT06004050","phase":"PHASE3","title":"A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2023-09-05","conditions":"Chronic Hand Eczema","enrollment":362},{"nctId":"NCT05355818","phase":"PHASE3","title":"Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2022-07-14","conditions":"Chronic Hand Eczema","enrollment":98},{"nctId":"NCT05259722","phase":"PHASE3","title":"A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2022-06-15","conditions":"Chronic Hand Eczema","enrollment":513},{"nctId":"NCT04872101","phase":"PHASE3","title":"Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2021-05-25","conditions":"Chronic Hand Eczema","enrollment":473},{"nctId":"NCT04871711","phase":"PHASE3","title":"Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2021-05-10","conditions":"Chronic Hand Eczema","enrollment":487},{"nctId":"NCT04949841","phase":"PHASE3","title":"Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2021-08-23","conditions":"Chronic Hand Eczema","enrollment":801},{"nctId":"NCT05486117","phase":"PHASE1","title":"Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2022-09-06","conditions":"Chronic Hand Eczema","enrollment":15},{"nctId":"NCT03683719","phase":"PHASE2","title":"Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2018-11-28","conditions":"Chronic Hand Eczema","enrollment":258},{"nctId":"NCT03725722","phase":"PHASE2","title":"Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2018-12-28","conditions":"Atopic Dermatitis","enrollment":251},{"nctId":"NCT05332366","phase":"PHASE2","title":"A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2022-04-19","conditions":"Frontal Fibrosing Alopecia","enrollment":35},{"nctId":"NCT03958955","phase":"PHASE2","title":"Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.","status":"TERMINATED","sponsor":"LEO Pharma","startDate":"2019-07-09","conditions":"Discoid Lupus Erythematosus","enrollment":27},{"nctId":"NCT04807751","phase":"PHASE1","title":"Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2021-03-25","conditions":"Healthy Volunteers","enrollment":60},{"nctId":"NCT04361136","phase":"PHASE1","title":"Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2020-04-23","conditions":"Healthy Volunteers","enrollment":35},{"nctId":"NCT03826901","phase":"PHASE1","title":"Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2019-02-20","conditions":"Atopic Dermatitis","enrollment":46}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":27,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["LEO 124249 cream"],"phase":"phase_3","status":"active","brandName":"Delgocitinib cream","genericName":"Delgocitinib cream","companyName":"LEO Pharma","companyId":"leo-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Delgocitinib is a JAK inhibitor that suppresses inflammatory cytokine signaling in immune cells to reduce skin inflammation and itching in atopic dermatitis. Used for Atopic dermatitis (topical cream formulation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":7,"withResults":5},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}