{"id":"montelukast-high-feno-group","rwe":[],"tags":[],"safety":{"boxedWarnings":["Neuropsychiatric events (e.g., agitation, aggressive behavior, depression, disorientation, hallucinations, insomnia, irritability, restlessness, suicidal thinking and behavior)"],"drugInteractions":["Warfarin: Monitor INR due to potential for increased anticoagulant effect","Phenytoin, carbamazepine, rifampin: May decrease montelukast plasma concentrations"],"commonSideEffects":[{"effect":"Headache","drugRate":"10%","severity":"Mild to moderate"},{"effect":"Pharyngitis","drugRate":"8%","severity":"Mild"},{"effect":"Upper respiratory infection","drugRate":"7%","severity":"Mild"},{"effect":"Abdominal pain","drugRate":"6%","severity":"Mild to moderate"},{"effect":"Diarrhea","drugRate":"5%","severity":"Mild"},{"effect":"Nasal congestion","drugRate":"4%","severity":"Mild"},{"effect":"Dizziness","drugRate":"3%","severity":"Mild"},{"effect":"Fatigue","drugRate":"2%","severity":"Mild"}],"contraindications":["Hypersensitivity to montelukast or any component of the formulation"],"specialPopulations":{"Geriatric":"No dose adjustment necessary; use with caution in patients with hepatic impairment","Lactation":"Excreted in breast milk; use with caution","Pediatric":"Approved for use in children aged 12 months and older","Pregnancy":"Category B: No evidence of harm in animal studies; use only if clearly needed"}},"trials":[],"_chembl":{"chemblId":"CHEMBL1200681","moleculeType":"Small molecule","molecularWeight":"608.18"},"aliases":["Montelukast"],"patents":[{"number":"US5656654A","issueDate":"1997-08-12","expirationDate":"2017-08-12"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1998","type":"Approval","milestone":"FDA approval for asthma","regulator":"FDA"},{"date":"2000","type":"Approval","milestone":"FDA approval for allergic rhinitis","regulator":"FDA"},{"date":"2023","type":"Safety update","milestone":"Boxed warning for neuropsychiatric events","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Montelukast is a leukotriene receptor antagonist used primarily for the treatment of asthma and allergic rhinitis. It is particularly effective in patients with high fractional exhaled nitric oxide (FeNO) levels, indicating significant eosinophilic airway inflammation. The drug works by blocking the action of leukotrienes, which are inflammatory mediators that contribute to bronchoconstriction and increased mucus production. Despite its efficacy, montelukast has been associated with several side effects, including neuropsychiatric events, which have led to caution in its use. The drug is not approved by the FDA for any specific indication related to high FeNO levels, but it remains a valuable option for managing asthma in certain patient populations.","ecosystem":[],"mechanism":{"target":"CysLT1 receptor","novelty":"Montelukast was one of the first selective leukotriene receptor antagonists to be developed and has been widely used for asthma management.","modality":"Oral tablet","drugClass":"Leukotriene receptor antagonist","explanation":"Leukotrienes are potent inflammatory mediators that cause bronchoconstriction, increased vascular permeability, and mucus secretion. By blocking the CysLT1 receptor, montelukast reduces these effects, leading to improved respiratory function.","oneSentence":"Montelukast is a selective leukotriene receptor antagonist that blocks the action of cysteinyl leukotrienes on the CysLT1 receptor, reducing inflammation and bronchoconstriction.","technicalDetail":"Montelukast selectively binds to the CysLT1 receptor, preventing the binding of cysteinyl leukotrienes such as LTC4, LTD4, and LTE4. This antagonism results in a reduction of the inflammatory response and bronchial hyperresponsiveness."},"_scrapedAt":"2026-03-27T23:55:47.022Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"1998","annualCostUS":"$100 - $300 per month","currentRevenue":"Not available","patientPopulation":"Estimated 10 million patients globally","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Fluticasone (Flovent)","Budesonide (Pulmicort)","Salmeterol (Serevent)","Zafirlukast (Accolate)"],"indications":{"approved":["Asthma","Allergic rhinitis"],"offLabel":["Exercise-induced bronchoconstriction"],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02479074","phase":"PHASE4","title":"The Utility of feNO in the Differential Diagnosis of Chronic Cough","status":"COMPLETED","sponsor":"Hull University Teaching Hospitals NHS Trust","startDate":"2016-01","conditions":"Cough","enrollment":49}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":["Teva Pharmaceuticals","Mylan Pharmaceuticals","Dr. Reddy's Laboratories"],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Respiratory"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Montelukast (High FeNO group)","genericName":"Montelukast (High FeNO group)","companyName":"Hull University Teaching Hospitals NHS Trust","companyId":"hull-university-teaching-hospitals-nhs-trust","modality":"Small molecule","firstApprovalDate":"1998","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"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},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}