{"id":"amenamevir","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"J05AX26","category":"atc"},{"label":"Active","category":"status"},{"label":"Herpes zoster","category":"indication"},{"label":"Recurrent herpes simplex","category":"indication"},{"label":"Maruho","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Maruho","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMENAMEVIR","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:21:49.547709+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:21:55.106047+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMENAMEVIR","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:21:55.625437+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Helicase primate complex inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:21:56.762555+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297592/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:21:56.344021+00:00"}},"allNames":"amenalief","offLabel":[],"synonyms":["amenamevir","amenalief"],"timeline":[{"date":"2017-07-03","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Maruho)"}],"brandName":"Amenalief","ecosystem":[{"indication":"Herpes zoster","otherDrugs":[{"name":"acyclovir","slug":"acyclovir","company":"Valeant Bermuda"},{"name":"famciclovir","slug":"famciclovir","company":"Novartis"},{"name":"valaciclovir","slug":"valaciclovir","company":"Glaxosmithkline"}],"globalPrevalence":null},{"indication":"Recurrent herpes simplex","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Amenalief is a viral replication inhibitor, but specific details on its target and mechanism of action are not available."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5266","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMENAMEVIR","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMENAMEVIR","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:40:15.686579","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:21:58.751705+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"enfuvirtide","drugSlug":"enfuvirtide","fdaApproval":"2003-03-13","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"maraviroc","drugSlug":"maraviroc","fdaApproval":"2007-08-06","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"maribavir","drugSlug":"maribavir","fdaApproval":"2021-11-23","patentExpiry":"Oct 27, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"letermovir","drugSlug":"letermovir","fdaApproval":"2017-11-08","patentExpiry":"Jan 18, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ibalizumab","drugSlug":"ibalizumab","fdaApproval":"2018-03-06","relationship":"same-class"},{"drugName":"tecovirimat","drugSlug":"tecovirimat","fdaApproval":"2018-07-13","patentExpiry":"Sep 4, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"baloxavir marboxil","drugSlug":"baloxavir-marboxil","fdaApproval":"2018-10-24","patentExpiry":"Sep 25, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fostemsavir","drugSlug":"fostemsavir","fdaApproval":"2020-07-02","patentExpiry":"Nov 19, 2027","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"amenamevir","indications":{"approved":[{"name":"Herpes zoster","source":"DrugCentral","snomedId":4740000,"regulator":"FDA"},{"name":"Recurrent herpes simplex","source":"DrugCentral","snomedId":37323009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"enfuvirtide","brandName":"enfuvirtide","genericName":"enfuvirtide","approvalYear":"2003","relationship":"same-class"},{"drugId":"maraviroc","brandName":"maraviroc","genericName":"maraviroc","approvalYear":"2007","relationship":"same-class"},{"drugId":"maribavir","brandName":"maribavir","genericName":"maribavir","approvalYear":"2021","relationship":"same-class"},{"drugId":"letermovir","brandName":"letermovir","genericName":"letermovir","approvalYear":"2017","relationship":"same-class"},{"drugId":"ibalizumab","brandName":"ibalizumab","genericName":"ibalizumab","approvalYear":"2018","relationship":"same-class"},{"drugId":"tecovirimat","brandName":"tecovirimat","genericName":"tecovirimat","approvalYear":"2018","relationship":"same-class"},{"drugId":"baloxavir-marboxil","brandName":"baloxavir marboxil","genericName":"baloxavir marboxil","approvalYear":"2018","relationship":"same-class"},{"drugId":"fostemsavir","brandName":"fostemsavir","genericName":"fostemsavir","approvalYear":"2020","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01959295","phase":"PHASE3","title":"Phase III Study of ASP2151 in Herpes Simplex Patients","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2013-08","conditions":["Herpes Simplex"],"enrollment":468,"completionDate":"2015-04-27"},{"nctId":"NCT02209324","phase":"PHASE3","title":"Open-label Study of ASP2151 in Herpes Simplex Patients","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2013-11","conditions":["Herpes Simplex"],"enrollment":275,"completionDate":"2015-08-20"},{"nctId":"NCT02280421","phase":"PHASE1","title":"Drug-Drug Interaction Study: ASP2151 and Ciclosporin","status":"COMPLETED","sponsor":"Maruho Europe Limited","startDate":"2014-10","conditions":["Healthy"],"enrollment":26,"completionDate":"2015-01"},{"nctId":"NCT02321748","phase":"PHASE1","title":"Drug-Drug Interaction Study: ASP2151 and Montelukast","status":"COMPLETED","sponsor":"Maruho Europe Limited","startDate":"2014-12","conditions":["Healthy"],"enrollment":24,"completionDate":"2015-04"},{"nctId":"NCT02223351","phase":"PHASE1","title":"Drug-Drug Interaction Study: ASP2151 and Ritonavir","status":"COMPLETED","sponsor":"Maruho Europe Limited","startDate":"2014-09","conditions":["Healthy"],"enrollment":48,"completionDate":"2014-12"},{"nctId":"NCT02369172","phase":"PHASE1","title":"Drug-Drug Interaction Study: ASP2151 and Bupropion","status":"COMPLETED","sponsor":"Maruho Europe Limited","startDate":"2015-02","conditions":["Healthy"],"enrollment":24,"completionDate":"2015-04"},{"nctId":"NCT02403635","phase":"PHASE1","title":"Drug-Drug Interaction Study: ASP2151 and Midazolam","status":"COMPLETED","sponsor":"Maruho Europe Limited","startDate":"2015-04","conditions":["Healthy"],"enrollment":27,"completionDate":"2015-05"},{"nctId":"NCT01959841","phase":"PHASE3","title":"Phase III Study of ASP2151 in Herpes Zoster Patients","status":"COMPLETED","sponsor":"Maruho Co., Ltd.","startDate":"2013-08","conditions":["Herpes Zoster"],"enrollment":751,"completionDate":"2015-07-10"},{"nctId":"NCT00487682","phase":"PHASE2","title":"Dose-finding Study of ASP2151 in Subjects With Herpes Zoster","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-11-13","conditions":["Herpes Zoster"],"enrollment":403,"completionDate":"2008-09-01"},{"nctId":"NCT00486200","phase":"PHASE2","title":"A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-06-21","conditions":["Herpes Genitalis"],"enrollment":695,"completionDate":"2008-08-12"},{"nctId":"NCT02796118","phase":"PHASE1","title":"Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-07","conditions":["Healthy Subjects"],"enrollment":36,"completionDate":"2006-10"},{"nctId":"NCT02852876","phase":"PHASE1","title":"Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food","status":"COMPLETED","sponsor":"Astellas Pharma Europe Ltd.","startDate":"2005-09","conditions":["Herpes Genitalis","Herpes Zoster"],"enrollment":72,"completionDate":"2005-12"},{"nctId":"NCT00870441","phase":"PHASE1","title":"Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers","status":"TERMINATED","sponsor":"Astellas Pharma Inc","startDate":"2009-03","conditions":["Safety of ASP2151"],"enrollment":442,"completionDate":"2010-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"94X46KW4AE","INN_ID":"9054","UMLSCUI":"C2983876","chemblId":"CHEMBL4297592","ChEMBL_ID":"CHEMBL4297592","KEGG_DRUG":"D10564","DRUGBANK_ID":"DB11701","PUBCHEM_CID":"11397521","MESH_SUPPLEMENTAL_RECORD_UI":"C568714"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Maruho","relationship":"Current Owner"}],"publicationCount":90,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"J05AX26","allCodes":["J05AX26"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Maruho","companyId":"maruho","modality":"Small molecule","firstApprovalDate":"2017","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"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":"2026-04-20T01:21:58.751705+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}