{"id":"amlexanox","rwe":[],"tags":[{"label":"amlexanox","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Inhibitor of nuclear factor kappa-B kinase subunit epsilon","category":"target"},{"label":"IKBKE","category":"gene"},{"label":"TBK1","category":"gene"},{"label":"GPR35","category":"gene"},{"label":"A01AD07","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Aphthous ulcer of mouth","category":"indication"},{"label":"Uluru","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[],"contraindications":["Stomatitis"]},"trials":[],"aliases":[],"company":"Uluru","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMLEXANOX","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:41:53.268531+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:41:59.588396+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMLEXANOX","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:42:00.319609+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Phosphodiesterase 4 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:00.908066+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1096/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:00.802547+00:00"}},"allNames":"amoxanox","offLabel":[],"synonyms":["aphthasol","amlexanox","amoxanox","aphtheal","amlenanox"],"timeline":[{"date":"1996-12-17","type":"positive","source":"DrugCentral","milestone":"FDA approval (Uluru)"},{"date":"2004-09-29","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Uluru)"}],"aiSummary":"Amlexanox, also known as AMLEXANOX, is a small molecule inhibitor of nuclear factor kappa-B kinase subunit epsilon. It was originally developed and is currently owned by ULURU. Amlexanox is used to treat aphthous ulcers of the mouth and was FDA approved in 1996. The drug is off-patent, meaning it is no longer protected by patents, and there are no generic manufacturers. As a result, its commercial status is uncertain.","brandName":"Amoxanox","ecosystem":[{"indication":"Aphthous ulcer of mouth","otherDrugs":[{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"},{"name":"sulfur","slug":"sulfur","company":"Poythress"},{"name":"triamcinolone","slug":"triamcinolone","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Inhibitor of nuclear factor kappa-B kinase subunit epsilon","novelty":"Follow-on","targets":[{"gene":"IKBKE","source":"DrugCentral","target":"Inhibitor of nuclear factor kappa-B kinase subunit epsilon","protein":"Inhibitor of nuclear factor kappa-B kinase subunit epsilon"},{"gene":"TBK1","source":"DrugCentral","target":"Serine/threonine-protein kinase TBK1","protein":"Serine/threonine-protein kinase TBK1"},{"gene":"GPR35","source":"DrugCentral","target":"G-protein coupled receptor 35","protein":"G-protein coupled receptor 35"},{"gene":"TTR","source":"DrugCentral","target":"Transthyretin","protein":"Transthyretin"},{"gene":"PDE4A","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4A"},{"gene":"PDE4B","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B"},{"gene":"PDE4C","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4C"},{"gene":"PDE4D","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4D"}],"modality":"Small Molecule","drugClass":"amlexanox","explanation":"","oneSentence":"","technicalDetail":"Amlexanox specifically inhibits the activity of IKKε, a kinase involved in the activation of NF-κB, a transcription factor that regulates the expression of genes involved in inflammation and immune response."},"commercial":{"launchDate":"1996","_launchSource":"DrugCentral (FDA 1996-12-17, ULURU)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/182","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMLEXANOX","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMLEXANOX","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":"2026-03-30T08:44:03.666778","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:42:02.794317+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"epinephrine","drugSlug":"epinephrine","fdaApproval":"1948-11-19","patentExpiry":"Oct 20, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"acetylsalicylic acid","drugSlug":"acetylsalicylic-acid","fdaApproval":"1950-04-12","relationship":"same-class"},{"drugName":"becaplermin","drugSlug":"becaplermin","fdaApproval":"1997-12-16","relationship":"same-class"}],"genericName":"amlexanox","indications":{"approved":[{"name":"Aphthous ulcer of mouth","source":"DrugCentral","snomedId":426965005,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"epinephrine","brandName":"epinephrine","genericName":"epinephrine","approvalYear":"1948","relationship":"same-class"},{"drugId":"acetylsalicylic-acid","brandName":"acetylsalicylic acid","genericName":"acetylsalicylic 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Radiation Therapy for Cancer of the Head and Neck Region","status":"COMPLETED","sponsor":"Access Pharmaceuticals, Inc.","startDate":"2000-02","conditions":["Oral Mucositis"],"enrollment":58,"completionDate":"2001-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"NUI":"N0000148519","MMSL":"11374","NDDF":"006853","UNII":"BRL1C2459K","VUID":"4021055","CHEBI":"CHEBI:31205","VANDF":"4021055","INN_ID":"5950","RXNORM":"320442","UMLSCUI":"C0103049","chemblId":"CHEMBL1096","ChEMBL_ID":"CHEMBL1096","KEGG_DRUG":"D01828","DRUGBANK_ID":"DB01025","PDB_CHEM_ID":"ANW","PUBCHEM_CID":"2161","SNOMEDCT_US":"108897008","IUPHAR_LIGAND_ID":"7113","MESH_SUPPLEMENTAL_RECORD_UI":"C045742"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1996-","companyName":"Uluru","relationship":"Original 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