{"id":"comparator-montelukast-loratadine","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Pharyngitis"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL1200681","moleculeType":"Small molecule","molecularWeight":"608.18"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Montelukast blocks cysteinyl leukotriene receptors on airway smooth muscle and inflammatory cells, reducing bronchoconstriction and inflammation. Loratadine competitively antagonizes H1 histamine receptors, reducing allergic symptoms such as itching, sneezing, and rhinitis. Together, they provide dual anti-inflammatory and antihistamine effects for allergic airway disease.","oneSentence":"This is a fixed-dose combination of montelukast (a cysteinyl leukotriene receptor antagonist) and loratadine (a selective H1-receptor antagonist) that reduces airway inflammation and blocks allergic mediators.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:07:04.341Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis and asthma (combination indication)"}]},"trialDetails":[{"nctId":"NCT00979901","phase":"PHASE3","title":"Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-03","conditions":"Seasonal Allergic Rhinitis","enrollment":1577},{"nctId":"NCT00963599","phase":"PHASE3","title":"Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"1999-09","conditions":"Seasonal Allergic Rhinitis","enrollment":907},{"nctId":"NCT00960141","phase":"PHASE3","title":"A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-08","conditions":"Seasonal Allergic Rhinitis","enrollment":829},{"nctId":"NCT00972738","phase":"PHASE3","title":"Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-04","conditions":"Seasonal Allergic Rhinitis","enrollment":1214},{"nctId":"NCT00963469","phase":"PHASE3","title":"Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-08","conditions":"Seasonal Allergic Rhinitis","enrollment":1079}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Comparator: montelukast/loratadine","genericName":"Comparator: montelukast/loratadine","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a fixed-dose combination of montelukast (a cysteinyl leukotriene receptor antagonist) and loratadine (a selective H1-receptor antagonist) that reduces airway inflammation and blocks allergic mediators. Used for Allergic rhinitis and asthma (combination indication).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}