{"id":"placebo-to-montelukast-chewable-tablets","safety":{"commonSideEffects":[{"rate":"12-18%","effect":"Headache"},{"rate":"2-4%","effect":"Dizziness"},{"rate":"2-3%","effect":"Dyspepsia"},{"rate":"1-2%","effect":"Elevated liver enzymes"},{"rate":"<1%","effect":"Neuropsychiatric events (rare)"}]},"_chembl":{"chemblId":"CHEMBL1200681","moleculeType":"Small molecule","molecularWeight":"608.18"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Montelukast selectively antagonizes cysteinyl leukotriene type-1 (CysLT1) receptors on airway smooth muscle and inflammatory cells. By blocking these receptors, it prevents the inflammatory cascade triggered by leukotrienes, which are potent mediators released during allergic and asthmatic responses. This reduces airway inflammation, mucus production, and bronchoconstriction.","oneSentence":"Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotriene receptors to reduce airway inflammation and bronchoconstriction.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:01:27.810Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma (prophylaxis and chronic treatment)"},{"name":"Allergic rhinitis"},{"name":"Exercise-induced bronchoconstriction"}]},"trialDetails":[{"nctId":"NCT00700661","phase":"PHASE3","title":"A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-01","conditions":"Asthma","enrollment":500},{"nctId":"NCT00092092","phase":"PHASE4","title":"Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-10","conditions":"Asthma, Bronchial","enrollment":71},{"nctId":"NCT01857063","phase":"PHASE3","title":"Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2013-06-10","conditions":"Seasonal Allergic Rhinitis","enrollment":220},{"nctId":"NCT00534976","phase":"PHASE4","title":"The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2008-02","conditions":"Exercise-induced Bronchoconstriction (EIB)","enrollment":364},{"nctId":"NCT00127166","phase":"PHASE3","title":"Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-12","conditions":"Exercise Induced Asthma","enrollment":154},{"nctId":"NCT02889809","phase":"PHASE4","title":"Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-07-10","conditions":"Asthma","enrollment":477},{"nctId":"NCT04351698","phase":"PHASE2, PHASE3","title":"SMILES: Study of Montelukast in Sickle Cell Disease","status":"UNKNOWN","sponsor":"Great Ormond Street Hospital for Children NHS Foundation Trust","startDate":"2023-10-16","conditions":"Anemia, Sickle Cell, Sleep-Disordered Breathing","enrollment":200},{"nctId":"NCT04075110","phase":"EARLY_PHASE1","title":"Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Sadat City University","startDate":"2019-07-01","conditions":"Obesity; Endocrine; Diabetes Type 2","enrollment":100},{"nctId":"NCT00540839","phase":"PHASE3","title":"A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)","status":"WITHDRAWN","sponsor":"Organon and Co","startDate":"2007-11","conditions":"Asthma, Bronchial","enrollment":""},{"nctId":"NCT00968201","phase":"PHASE3","title":"Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )","status":"COMPLETED","sponsor":"Organon and Co","startDate":"1997-12","conditions":"Asthma","enrollment":689},{"nctId":"NCT00461032","phase":"PHASE3","title":"Montelukast Back to School Asthma Study (0476-340)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-06","conditions":"Asthma","enrollment":1162},{"nctId":"NCT00289874","phase":"PHASE3","title":"Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-03","conditions":"Asthma","enrollment":421},{"nctId":"NCT02483975","phase":"PHASE3","title":"Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-10-09","conditions":"Asthma","enrollment":111},{"nctId":"NCT03096327","phase":"PHASE4","title":"TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)","status":"COMPLETED","sponsor":"PharmEvo Pvt Ltd","startDate":"2017-05-01","conditions":"Asthma","enrollment":180},{"nctId":"NCT00557284","phase":"PHASE4","title":"Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens","status":"COMPLETED","sponsor":"1st Allergy & Clinical Research Center","startDate":"2008-03","conditions":"Atopic Dermatitis","enrollment":20},{"nctId":"NCT00565955","phase":"PHASE3","title":"Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children","status":"COMPLETED","sponsor":"All India Institute of Medical Sciences","startDate":"2007-03","conditions":"Bronchial Asthma","enrollment":116}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Placebo to montelukast chewable tablets","genericName":"Placebo to montelukast chewable tablets","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotriene receptors to reduce airway inflammation and bronchoconstriction. Used for Asthma (prophylaxis and chronic treatment), Allergic rhinitis, Exercise-induced bronchoconstriction.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}