{"id":"montelukast-levocetirizine","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Pharyngitis"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1200681","moleculeType":"Small molecule","molecularWeight":"608.18"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Montelukast is a selective cysteinyl leukotriene receptor antagonist that inhibits the inflammatory cascade triggered by leukotrienes, which are potent mediators of allergic and asthmatic responses. Levocetirizine is a selective H1-receptor antagonist that blocks histamine-mediated allergic symptoms. Together, they provide dual anti-inflammatory and antihistamine activity for allergic conditions.","oneSentence":"This combination blocks cysteinyl leukotriene receptors (montelukast) and histamine H1 receptors (levocetirizine) to reduce allergic inflammation and symptoms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:00.694Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis"},{"name":"Asthma (allergic component)"},{"name":"Allergic conditions with combined leukotriene and histamine involvement"}]},"trialDetails":[{"nctId":"NCT04324918","phase":"PHASE3","title":"Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2018-10-23","conditions":"Perennial Allergic Rhinitis","enrollment":174},{"nctId":"NCT00295022","phase":"PHASE4","title":"Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects","status":"COMPLETED","sponsor":"UCB S.A. - Pharma Sector","startDate":"2006-07-29","conditions":"Rhinitis, Allergic, Seasonal","enrollment":418},{"nctId":"NCT03371849","phase":"PHASE1","title":"PK and Safety Study of HCP1102, HGP0813 and HGP1408","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2017-07-19","conditions":"Healthy","enrollment":24},{"nctId":"NCT02551536","phase":"PHASE4","title":"Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis","status":"COMPLETED","sponsor":"Indira Gandhi Medical College, Shimla","startDate":"2014-04","conditions":"Allergic Rhinitis","enrollment":70},{"nctId":"NCT00315523","phase":"PHASE3","title":"Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen","status":"COMPLETED","sponsor":"UCB Pharma","startDate":"2006-07","conditions":"Rhinitis, Allergic, Seasonal","enrollment":403},{"nctId":"NCT01651481","phase":"PHASE1","title":"Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2012-07","conditions":"Rhinitis","enrollment":28},{"nctId":"NCT01640535","phase":"PHASE3","title":"Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2012-06","conditions":"Perennial Allergic Rhinitis","enrollment":283},{"nctId":"NCT01491503","phase":"PHASE1","title":"A Drug Interaction Study of Montelukast and Levocetirizine","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2011-11","conditions":"Healthy","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Singulair Tablet, Xyzal Tablet"],"phase":"phase_3","status":"active","brandName":"Montelukast + Levocetirizine","genericName":"Montelukast + Levocetirizine","companyName":"Hanmi Pharmaceutical Company Limited","companyId":"hanmi-pharmaceutical-company-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination blocks cysteinyl leukotriene receptors (montelukast) and histamine H1 receptors (levocetirizine) to reduce allergic inflammation and symptoms. Used for Allergic rhinitis, Asthma (allergic component), Allergic conditions with combined leukotriene and histamine involvement.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}