{"id":"opa-15406","safety":{"commonSideEffects":[{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Application site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OPA-15406 selectively inhibits Janus kinase 1 (JAK1), a key enzyme in the JAK-STAT signaling pathway that drives inflammatory and immune responses. By blocking JAK1, the drug suppresses the production of pro-inflammatory cytokines and reduces pathogenic T-cell activation, thereby ameliorating symptoms in conditions like atopic dermatitis and other inflammatory skin disorders.","oneSentence":"OPA-15406 is a selective JAK1 inhibitor that reduces inflammatory signaling to treat immune-mediated skin diseases.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:24.160Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis"},{"name":"Other inflammatory skin conditions"}]},"trialDetails":[{"nctId":"NCT07184645","phase":"PHASE3","title":"A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2025-09","conditions":"Atopic Dermatitis (AD)","enrollment":198},{"nctId":"NCT07173478","phase":"PHASE3","title":"A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2025-10","conditions":"Atopic Dermatitis (AD)","enrollment":156},{"nctId":"NCT05667623","phase":"PHASE3","title":"To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2023-02-06","conditions":"Atopic Dermatitis (AD)","enrollment":270},{"nctId":"NCT05372653","phase":"PHASE3","title":"A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2022-05-23","conditions":"Atopic Dermatitis (AD)","enrollment":41},{"nctId":"NCT05650320","phase":"PHASE3","title":"To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2023-02-17","conditions":"Atopic Dermatitis (AD)","enrollment":240},{"nctId":"NCT02068352","phase":"PHASE2","title":"A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2014-06-20","conditions":"Atopic Dermatitis","enrollment":121},{"nctId":"NCT03961529","phase":"PHASE3","title":"Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2019-05-14","conditions":"Atopic Dermatitis","enrollment":366},{"nctId":"NCT03911401","phase":"PHASE3","title":"Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2019-05-07","conditions":"Atopic Dermatitis","enrollment":251},{"nctId":"NCT03908970","phase":"PHASE3","title":"Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2019-03-25","conditions":"Atopic Dermatitis","enrollment":364},{"nctId":"NCT03018691","phase":"PHASE2","title":"Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2017-01","conditions":"Atopic Dermatitis","enrollment":73},{"nctId":"NCT02914548","phase":"PHASE2","title":"Study of OPA-15406 Ointment in Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2016-09","conditions":"Atopic Dermatitis","enrollment":200},{"nctId":"NCT02945657","phase":"PHASE2","title":"Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis","status":"COMPLETED","sponsor":"Medimetriks Pharmaceuticals, Inc","startDate":"2016-10","conditions":"Atopic Dermatitis","enrollment":32},{"nctId":"NCT02334787","phase":"PHASE1","title":"A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2015-01","conditions":"Atopic Dermatitis","enrollment":32},{"nctId":"NCT01702181","phase":"PHASE1","title":"A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2012-08","conditions":"Atopic Dermatitis","enrollment":92}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["difamilast"],"phase":"phase_3","status":"active","brandName":"OPA-15406","genericName":"OPA-15406","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OPA-15406 is a selective JAK1 inhibitor that reduces inflammatory signaling to treat immune-mediated skin diseases. Used for Atopic dermatitis, Other inflammatory skin conditions.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}