{"id":"difamilast","rwe":[{"pmid":"41860296","year":"2026","title":"Phosphodiesterase 4 Inhibitor Use in Pediatric Patients With Atopic Dermatitis: A Meta-Analysis of Randomized Controlled Trials.","finding":"","journal":"Advances in skin & wound care","studyType":"Clinical Study"},{"pmid":"41618061","year":"2026","title":"Efficacy and safety of treatments for atopic dermatitis: a model based meta-analysis of randomized controlled trials.","finding":"","journal":"European journal of clinical pharmacology","studyType":"Clinical Study"},{"pmid":"41589051","year":"2026","title":"Difamilast Ointment, a Topical PDE4 Inhibitor, for Pediatric Cheilitis Granulomatosa: A Steroid-Sparing Outcome.","finding":"","journal":"The Journal of dermatology","studyType":"Clinical Study"},{"pmid":"41171590","year":"2026","title":"A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.","finding":"","journal":"Dermatology and therapy","studyType":"Clinical Study"},{"pmid":"40864813","year":"2025","title":"Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.","finding":"","journal":"Current issues in molecular biology","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B","category":"target"},{"label":"PDE4B","category":"gene"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Atopic dermatitis","category":"indication"},{"label":"OTSUKA PHARMACEUTICAL Co., Ltd","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"OTSUKA PHARMACEUTICAL Co., Ltd","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DIFAMILAST","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:14:09.360851+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:14:16.403213+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIFAMILAST","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:14:17.146694+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Phosphodiesterase 4 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:17.705348+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989968/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:17.602969+00:00"}},"allNames":"moizerto","offLabel":[],"synonyms":["difamilast","moizerto","OPA-15406","MM36"],"timeline":[{"date":"2021-09-27","type":"positive","source":"DrugCentral","milestone":"PMDA approval (OTSUKA PHARMACEUTICAL Co., Ltd)"},{"date":"2031-02-12","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"}],"aiSummary":"Moizerto (DIFAMILAST) is a small molecule drug developed by OTSUKA PHARMACEUTICAL Co., Ltd and currently owned by Acrotech Biopharma. It targets cAMP-specific 3',5'-cyclic phosphodiesterase 4B, a specific enzyme involved in inflammation. Moizerto is approved to treat atopic dermatitis, a chronic skin condition characterized by inflammation and itching. The drug is off-patent, meaning it is no longer protected by patents, and there are currently no generic manufacturers. As a result, its commercial status and availability may be limited.","approvals":[{"date":"2021-09-27","orphan":false,"company":"OTSUKA PHARMACEUTICAL Co., Ltd","regulator":"PMDA"}],"brandName":"Moizerto","ecosystem":[{"indication":"Atopic dermatitis","otherDrugs":[{"name":"abrocitinib","slug":"abrocitinib","company":"PFIZER Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"}],"globalPrevalence":204050000}],"mechanism":{"target":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B","targets":[{"gene":"PDE4B","source":"DrugCentral","target":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Moizerto specifically inhibits the activity of cAMP-specific 3',5'-cyclic phosphodiesterase 4B (PDE4B), a key enzyme involved in the regulation of cAMP levels in immune cells, thereby reducing the production of pro-inflammatory cytokines and mediators."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5503","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DIFAMILAST","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIFAMILAST","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:35:35.164787","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:14:19.501750+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"apremilast","drugSlug":"apremilast","fdaApproval":"2014-03-21","patentExpiry":"Nov 29, 2034","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"diprophylline","drugSlug":"diprophylline","fdaApproval":"1951-03-07","relationship":"same-target"},{"drugName":"papaverine","drugSlug":"papaverine","fdaApproval":"","relationship":"same-target"},{"drugName":"pentoxifylline","drugSlug":"pentoxifylline","fdaApproval":"1984-08-30","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"roflumilast","drugSlug":"roflumilast","fdaApproval":"2011-02-28","patentExpiry":"Jun 7, 2037","patentStatus":"Patent protected","relationship":"same-target"}],"exclusivity":[{"code":"NCE","date":"Feb 12, 2031"}],"genericName":"difamilast","indications":{"approved":[{"name":"Atopic dermatitis","source":"DrugCentral","snomedId":24079001,"regulator":"FDA","usPrevalence":null,"globalPrevalence":204050000,"prevalenceMethod":"curated","prevalenceSource":"Br J Dermatol, 2023 (PMID:37705227)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Acrotech Biopharma","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"apremilast","brandName":"apremilast","genericName":"apremilast","approvalYear":"2014","relationship":"same-target"},{"drugId":"diprophylline","brandName":"diprophylline","genericName":"diprophylline","approvalYear":"1951","relationship":"same-target"},{"drugId":"papaverine","brandName":"papaverine","genericName":"papaverine","approvalYear":"","relationship":"same-target"},{"drugId":"pentoxifylline","brandName":"pentoxifylline","genericName":"pentoxifylline","approvalYear":"1984","relationship":"same-target"},{"drugId":"roflumilast","brandName":"roflumilast","genericName":"roflumilast","approvalYear":"2011","relationship":"same-target"}],"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,"completionDate":"2027-02"},{"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,"completionDate":"2026-12"},{"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,"completionDate":"2024-11-29"},{"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,"completionDate":"2023-11-29"},{"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,"completionDate":"2025-01-15"},{"nctId":"NCT05608343","phase":"PHASE3","title":"This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)","status":"COMPLETED","sponsor":"Acrotech Biopharma Inc.","startDate":"2022-10-01","conditions":["Atopic Dermatitis"],"enrollment":153,"completionDate":"2023-10-27"},{"nctId":"NCT05571943","phase":"PHASE3","title":"A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Acrotech Biopharma Inc.","startDate":"2022-09-15","conditions":["Atopic Dermatitis"],"enrollment":542,"completionDate":"2024-07-31"},{"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,"completionDate":"2015-02-03"},{"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,"completionDate":"2019-12-13"},{"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,"completionDate":"2019-12-28"},{"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,"completionDate":"2017-06"},{"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,"completionDate":"2017-06"},{"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,"completionDate":"2017-06-08"},{"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,"completionDate":"2013-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"UNII":"T3U32GLJ0F","INN_ID":"10717","UMLSCUI":"C5139795","chemblId":"CHEMBL3989968","ChEMBL_ID":"CHEMBL3989968","KEGG_DRUG":"D11314","DRUGBANK_ID":"DB14987","PUBCHEM_CID":"57855696","IUPHAR_LIGAND_ID":"9776","MESH_SUPPLEMENTAL_RECORD_UI":"C000711049"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Acrotech Biopharma","relationship":"Current Owner"},{"period":"2021","companyName":"OTSUKA PHARMACEUTICAL Co., Ltd","relationship":"PMDA Licensee"}],"publicationCount":36,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Apr 1","pmid":"41860296","title":"Phosphodiesterase 4 Inhibitor Use in Pediatric Patients With Atopic Dermatitis: A Meta-Analysis of Randomized Controlled Trials.","journal":"Advances in skin & wound care"},{"date":"2026 Jan 31","pmid":"41618061","title":"Efficacy and safety of treatments for atopic dermatitis: a model based meta-analysis of randomized controlled trials.","journal":"European journal of clinical pharmacology"},{"date":"2026 Jan 27","pmid":"41589051","title":"Difamilast Ointment, a Topical PDE4 Inhibitor, for Pediatric Cheilitis Granulomatosa: A Steroid-Sparing Outcome.","journal":"The Journal of dermatology"},{"date":"2026 Jan","pmid":"41171590","title":"A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.","journal":"Dermatology and therapy"},{"date":"2025 Aug 15","pmid":"40864813","title":"Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.","journal":"Current issues in molecular biology"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"active","companyName":"Acrotech Biopharma","companyId":"otsuka-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2021-09-27T00:00:00.000Z","mah":"OTSUKA PHARMACEUTICAL Co., Ltd","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:14:19.501750+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}