{"id":"pranlukast","rwe":[],"tags":[{"label":"pranlukast","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Cysteinyl leukotriene receptor 1","category":"target"},{"label":"CYSLTR1","category":"gene"},{"label":"CYSLTR2","category":"gene"},{"label":"GPR17","category":"gene"},{"label":"R03DC02","category":"atc"},{"label":"Active","category":"status"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Asthma","category":"indication"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Hormone Antagonists","category":"pharmacology"},{"label":"Leukotriene Antagonists","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":57.774,"date":"","count":27,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=58)"},{"llr":46.026,"date":"","count":30,"signal":"Asthma","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=46)"},{"llr":44.847,"date":"","count":11,"signal":"Eosinophilic granulomatosis with polyangiitis","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=45)"},{"llr":35.458,"date":"","count":52,"signal":"Pneumonia","source":"DrugCentral FAERS","actionTaken":"Reported 52 times (LLR=35)"},{"llr":34.976,"date":"","count":9,"signal":"Upper respiratory tract inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=35)"},{"llr":34.537,"date":"","count":51,"signal":"Pyrexia","source":"DrugCentral FAERS","actionTaken":"Reported 51 times (LLR=35)"},{"llr":28.198,"date":"","count":10,"signal":"Concomitant disease aggravated","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=28)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PRANLUKAST","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:43:58.475566+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:44:03.912055+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PRANLUKAST","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:44:04.333565+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1085767/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:44:05.044147+00:00"}},"allNames":"onon","offLabel":[],"synonyms":["ONO 1078","pranlukast","onon","azlaire","pranlukast hydrate","ONO-1078"],"timeline":[{"date":"2007-03-15","type":"positive","source":"DrugCentral","milestone":"PMDA approval"}],"aiSummary":"Onon (PRANLUKAST) is a small molecule drug that targets the cysteinyl leukotriene receptor 1. It is used to treat allergic rhinitis and asthma by blocking the action of leukotrienes, which are chemical messengers involved in inflammation. The commercial status of Onon is not specified, but it is a pranlukast drug class. Key safety considerations are not provided. Onon is used to alleviate symptoms of allergic rhinitis and asthma.","approvals":[{"date":"2007-03-15","orphan":false,"company":"","regulator":"PMDA"}],"brandName":"Onon","ecosystem":[{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Asthma","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"}],"globalPrevalence":262000000}],"mechanism":{"target":"Cysteinyl leukotriene receptor 1","targets":[{"gene":"CYSLTR1","source":"DrugCentral","target":"Cysteinyl leukotriene receptor 1","protein":"Cysteinyl leukotriene receptor 1"},{"gene":"CYSLTR2","source":"DrugCentral","target":"Cysteinyl leukotriene receptor 2","protein":"Cysteinyl leukotriene receptor 2"},{"gene":"GPR17","source":"DrugCentral","target":"Uracil nucleotide/cysteinyl leukotriene receptor","protein":"Uracil nucleotide/cysteinyl leukotriene receptor"},{"gene":"NR1H4","source":"DrugCentral","target":"Bile acid receptor","protein":"Bile acid receptor"}],"modality":"Small Molecule","drugClass":"pranlukast","explanation":"","oneSentence":"","technicalDetail":"Onon (PRANLUKAST) is a selective antagonist of the cysteinyl leukotriene receptor 1 (CysLT1R), which is a G-protein coupled receptor involved in the regulation of inflammatory responses."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2237","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PRANLUKAST","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PRANLUKAST","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:24:16.562606","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:44:06.659540+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"zafirlukast","drugSlug":"zafirlukast","fdaApproval":"1996-09-26","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"montelukast","drugSlug":"montelukast","fdaApproval":"1998-02-20","genericCount":30,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"pranlukast","indications":{"approved":[{"name":"Allergic rhinitis","source":"DrugCentral","snomedId":61582004,"regulator":"FDA"},{"name":"Asthma","source":"DrugCentral","snomedId":195967001,"regulator":"FDA","usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"zafirlukast","brandName":"zafirlukast","genericName":"zafirlukast","approvalYear":"1996","relationship":"same-class"},{"drugId":"montelukast","brandName":"montelukast","genericName":"montelukast","approvalYear":"1998","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07231861","phase":"PHASE1","title":"Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers","status":"NOT_YET_RECRUITING","sponsor":"AJU Pharm Co., Ltd.","startDate":"2025-12","conditions":["Bronchial Asthma","Perennial Allergic Rhinitis"],"enrollment":60,"completionDate":"2025-12"},{"nctId":"NCT00127647","phase":"PHASE3","title":"An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-11","conditions":["Rhinitis, Allergic, Seasonal"],"enrollment":1375,"completionDate":"2005-04"},{"nctId":"NCT03826485","phase":"PHASE1","title":"Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects","status":"UNKNOWN","sponsor":"SamA Pharmaceutical Co., Ltd","startDate":"2019-04-01","conditions":["Healthy"],"enrollment":48,"completionDate":"2019-07-31"},{"nctId":"NCT00410735","phase":"PHASE3","title":"Study of ONO-1078 in Patients With Chronic Sinusitis","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2006-12","conditions":["Chronic Sinusitis"],"enrollment":495,"completionDate":""},{"nctId":"NCT01539304","phase":"PHASE3","title":"Clinical Trial to Evaluate the Safety and Efficacy of \"CITUS Dry Syrup\" in Children With Perennial Allergic Rhinitis","status":"COMPLETED","sponsor":"SamA Pharmaceutical Co., Ltd","startDate":"2010-09","conditions":["Perennial Allergic Rhinitis"],"enrollment":245,"completionDate":"2011-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"TB8Z891092","CHEBI":"CHEBI:94810","INN_ID":"6943","UMLSCUI":"C0526058","chemblId":"CHEMBL1085767","ChEMBL_ID":"CHEMBL21333","KEGG_DRUG":"D02732","DRUGBANK_ID":"DB01411","PDB_CHEM_ID":" KNT","PUBCHEM_CID":"4887","SNOMEDCT_US":"713438006","IUPHAR_LIGAND_ID":"3634","MESH_SUPPLEMENTAL_RECORD_UI":"C047681"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":394,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"R03DC02","allCodes":["R03DC02"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1995","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2007-03-15T00:00:00.000Z","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":0,"lastValidatedAt":"2026-04-20T03:44:06.659540+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}