{"id":"egualen","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Gastric ulcer","category":"indication"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=EGUALEN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:52:36.335768+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:52:50.900779+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:52:41.711725+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EGUALEN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:52:42.148673+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2105570/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:43.168251+00:00"}},"allNames":"azuloxa","offLabel":[],"synonyms":["azuloxa","egualen sodium hydrate","egualen sodium","KT1–32","egualen","azuletil"],"timeline":[],"aiSummary":"EGUALEN (Azuloxa) is a marketed drug primarily indicated for the treatment of gastric ulcers, leveraging its mechanism of inhibiting stomach acid production to facilitate healing and prevention. A key strength of EGUALEN is its strong patent protection, with the key composition patent expiring in 2028, providing a significant barrier to generic competition. The primary risk for EGUALEN is the potential loss of exclusivity post-2028, which could lead to increased competition from generics.","approvals":[{"date":"","orphan":false,"company":"","regulator":"PMDA"}],"brandName":"Azuloxa","ecosystem":[{"indication":"Gastric ulcer","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"cimetidine","slug":"cimetidine","company":""},{"name":"famotidine","slug":"famotidine","company":"Valeant Pharms North"},{"name":"lansoprazole","slug":"lansoprazole","company":"Takeda Pharms Usa"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"The exact mechanism of action of Azuloxa is unclear, but it is thought to involve the inhibition of gastric acid secretion, possibly through the blockade of histamine H2 receptors or the inhibition of parietal cell function."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/993","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EGUALEN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:53:12.290788","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:52:50.900920+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"egualen","indications":{"approved":[{"name":"Gastric ulcer","source":"DrugCentral","snomedId":397825006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"17VM9WN49U","CHEBI":"CHEBI:85542","INN_ID":"6823","UMLSCUI":"C2348385","chemblId":"CHEMBL2105570","ChEMBL_ID":"CHEMBL2105570","PUBCHEM_CID":"65858","SECONDARY_CAS_RN":"97683-31-3","MESH_SUPPLEMENTAL_RECORD_UI":"C061956"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":6,"therapeuticAreas":["Dermatology"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":null,"mah":"","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":1,"lastValidatedAt":"2026-04-20T00:52:50.900920+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}