{"id":"salmeterol-50-mcg-via-diskus","rwe":[],"tags":[],"safety":{"boxedWarnings":["Increased risk of asthma-related death when used without an inhaled corticosteroid"],"drugInteractions":[{"drug":"Monoamine oxidase inhibitors (MAOIs)","interaction":"May potentiate the effects of salmeterol, leading to increased heart rate and blood pressure"},{"drug":"Tricyclic antidepressants","interaction":"May increase the risk of cardiac arrhythmias when used concomitantly with salmeterol"}],"commonSideEffects":[{"effect":"Upper respiratory tract infection","drugRate":"10%","severity":"Mild"},{"effect":"Headache","drugRate":"8%","severity":"Mild"},{"effect":"Muscle pain","drugRate":"5%","severity":"Mild"},{"effect":"Pharyngitis","drugRate":"4%","severity":"Mild"},{"effect":"Sinusitis","drugRate":"3%","severity":"Mild"},{"effect":"Nasal congestion","drugRate":"2%","severity":"Mild"}],"contraindications":["Hypersensitivity to salmeterol or any component of the formulation"],"specialPopulations":{"Geriatric":"No overall differences in safety or effectiveness between elderly and younger patients, but greater sensitivity cannot be ruled out","Lactation":"Excreted in human milk; caution should be exercised","Pediatric":"Safety and effectiveness in children under 4 years of age have not been established","Pregnancy":"Category C: Risk cannot be ruled out"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"title":"Salmeterol xinafoate and processes for its preparation","number":"US5541195","issueDate":"1996-07-30","expirationDate":"2016-07-30"}],"pricing":[],"allNames":["salmeterol"],"offLabel":[],"timeline":[{"date":"1994","type":"Approval","milestone":"First approval for asthma","regulator":"FDA"},{"date":"2003","type":"Approval","milestone":"Approval for COPD","regulator":"FDA"},{"date":"2005","type":"Safety Update","milestone":"Black box warning added for asthma-related deaths","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Salmeterol 50 mcg via DISKUS is a long-acting beta2-adrenergic agonist (LABA) developed by GlaxoSmithKline for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles in the airways to improve breathing. Despite its effectiveness, it carries warnings about the risk of asthma-related death when used without an inhaled corticosteroid. Common side effects include upper respiratory tract infections, headache, and muscle pain. The drug has no FDA label, which may affect its market presence and regulatory status.","ecosystem":[],"mechanism":{"target":"Beta2-adrenergic receptors","novelty":"Salmeterol was one of the first LABAs to be approved for the maintenance treatment of asthma and COPD.","modality":"Inhalation","drugClass":"Long-acting beta2-adrenergic agonist (LABA)","explanation":"Salmeterol binds to and activates beta2-adrenergic receptors on bronchial smooth muscle cells, leading to the relaxation of these muscles and improved airflow.","oneSentence":"Salmeterol is a long-acting beta2-adrenergic agonist that relaxes bronchial smooth muscle to improve airflow.","technicalDetail":"The activation of beta2-adrenergic receptors by salmeterol results in the stimulation of adenylate cyclase, which increases intracellular cyclic AMP (cAMP) levels. This leads to the activation of protein kinase A (PKA), which phosphorylates and inactivates myosin light-chain kinase (MLCK), resulting in smooth muscle relaxation."},"_scrapedAt":"2026-03-28T00:06:41.977Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"2%","launchDate":"1994","annualCostUS":"$300","currentRevenue":"$1.5 billion","patientPopulation":"Approximately 30 million patients worldwide","peakSalesEstimate":"$2.0 billion"},"references":[],"biosimilars":[],"competitors":["Advair Diskus (fluticasone propionate and salmeterol, GlaxoSmithKline)","Spiriva (tiotropium bromide, Boehringer Ingelheim)","Brovana (arformoterol tartrate, Sunovion Pharmaceuticals)"],"indications":{"approved":["Asthma","Chronic obstructive pulmonary disease (COPD)"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00424008","phase":"PHASE3","title":"Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-04","conditions":"Asthma","enrollment":722},{"nctId":"NCT01225913","phase":"PHASE4","title":"Mechanism(s) of Airflow Limitation During Exacerbation of Asthma","status":"RECRUITING","sponsor":"Gelb, Arthur F., M.D.","startDate":"2007-10","conditions":"Asthma","enrollment":50},{"nctId":"NCT03363503","phase":"PHASE4","title":"Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD","status":"TERMINATED","sponsor":"Neutec Ar-Ge San ve Tic A.Ş","startDate":"2018-04-13","conditions":"COPD","enrollment":64},{"nctId":"NCT02245672","phase":"PHASE3","title":"MGR001 / Advair Diskus Local Equivalence Study in Asthma","status":"COMPLETED","sponsor":"Mylan Pharma UK Ltd.","startDate":"2014-10","conditions":"Asthma","enrollment":1128},{"nctId":"NCT02924688","phase":"PHASE3","title":"A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-10-13","conditions":"Asthma","enrollment":2436},{"nctId":"NCT03395002","phase":"PHASE4","title":"Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment","status":"COMPLETED","sponsor":"Neutec Ar-Ge San ve Tic A.Ş","startDate":"2018-03-22","conditions":"COPD","enrollment":58},{"nctId":"NCT03034915","phase":"PHASE4","title":"A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-06-16","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":2696},{"nctId":"NCT03535870","phase":"NA","title":"Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg)","status":"COMPLETED","sponsor":"West-Ward Pharmaceutical","startDate":"2018-04-26","conditions":"Asthma","enrollment":1556},{"nctId":"NCT03376932","phase":"PHASE3","title":"Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2019-01-18","conditions":"Asthma","enrollment":""},{"nctId":"NCT02516592","phase":"PHASE4","title":"Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-10-13","conditions":"COPD","enrollment":500},{"nctId":"NCT01494610","phase":"PHASE1, PHASE2","title":"Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-10-25","conditions":"Asthma","enrollment":60},{"nctId":"NCT00118716","phase":"PHASE4","title":"A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-12-23","conditions":"Bronchospasm, Activity/Exercise Induced Bronchospasm","enrollment":248},{"nctId":"NCT02446418","phase":"PHASE3","title":"A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-07-09","conditions":"Asthma","enrollment":423},{"nctId":"NCT02301975","phase":"PHASE3","title":"An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-03-01","conditions":"Asthma","enrollment":1526},{"nctId":"NCT00355342","phase":"PHASE4","title":"Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-04-28","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":186},{"nctId":"NCT01890863","phase":"PHASE1","title":"ROTAHALER Device Optimization Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-08-05","conditions":"Asthma","enrollment":36},{"nctId":"NCT01706328","phase":"PHASE3","title":"A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-10-15","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":828},{"nctId":"NCT00372112","phase":"PHASE2","title":"A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-11-03","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":68},{"nctId":"NCT00363480","phase":"PHASE4","title":"Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-05-17","conditions":"Asthma","enrollment":221},{"nctId":"NCT00455923","phase":"PHASE4","title":"SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-05-03","conditions":"Asthma","enrollment":100},{"nctId":"NCT02649478","phase":"NA","title":"Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2014-08","conditions":"Asthma","enrollment":1430},{"nctId":"NCT01817764","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":707},{"nctId":"NCT01879410","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-06-13","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":700},{"nctId":"NCT01822899","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-04-04","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":717},{"nctId":"NCT02260492","phase":"PHASE1","title":"Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma","status":"COMPLETED","sponsor":"Oriel Therapeutics","startDate":"2014-09","conditions":"Asthma","enrollment":879},{"nctId":"NCT01772368","phase":"PHASE2","title":"Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2013-01","conditions":"Asthma","enrollment":72},{"nctId":"NCT02055352","phase":"PHASE4","title":"Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-05-30","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":222},{"nctId":"NCT00497237","phase":"PHASE3","title":"Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2007-04","conditions":"Asthma","enrollment":382},{"nctId":"NCT00197106","phase":"PHASE4","title":"Treatment Of Symptomatic Asthma In Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-06","conditions":"Asthma","enrollment":176},{"nctId":"NCT00361959","phase":"PHASE4","title":"SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-06","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1270},{"nctId":"NCT02218762","phase":"PHASE1","title":"A Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the ROTAHALER® Inhaler Relative to the DISKUS® Inhaler","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2014-10","conditions":"Asthma","enrollment":""},{"nctId":"NCT01391559","phase":"NA","title":"Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"2011-07","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":20},{"nctId":"NCT01361984","phase":"PHASE4","title":"Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography","status":"UNKNOWN","sponsor":"University of California, Los Angeles","startDate":"2011-06","conditions":"Chronic Obstructive Pulmonary Disease, COPD, Emphysema","enrollment":20},{"nctId":"NCT00655616","phase":"NA","title":"Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics","status":"COMPLETED","sponsor":"University of Dundee","startDate":"2007-08","conditions":"Asthma","enrollment":64}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":["Teva Pharmaceutical Industries Ltd.","Mylan N.V.","Apotex Inc."],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":5,"therapeuticAreas":["Respiratory"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Salmeterol 50 mcg via DISKUS","genericName":"Salmeterol 50 mcg via DISKUS","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"1994","enrichmentLevel":3,"visitCount":1,"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":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}