Singulair

(Montelukast)

ApprovedSmall molecule

Montelukast is used to prevent and treat asthma symptoms and to relieve allergy symptoms like sneezing and itchy nose. It works by blocking substances in the body that cause inflammation and narrowing of airways.[2] Singulair is currently approved and in use across 56 indications[4].[1]

Singulair is one of 724 small molecule programs targeting Nephrotic Syndrome. It is currently in Approved.

Indications

187

Total Trials

Active Trials

723

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Nephrotic SyndromeActive, not recruiting

BronchiolitisActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Non-Alcoholic SteatohepatitisApproved

Alzheimer DiseaseApproved

Premature BirthApproved

Diabetic NephropathyApproved

Airway ObstructionActive, not recruiting

Allergic AsthmaActive, not recruiting

Nephrotic SyndromePreclinical

Active, not recruiting

BronchiolitisPreclinical

Active, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Chronic Kidney DiseasePreclinical

Active, not recruiting

Non-Alcoholic SteatohepatitisApproved

Approved

Alzheimer DiseaseApproved

Approved

Premature BirthApproved

Approved

Diabetic NephropathyApproved

Approved

Airway ObstructionApproved

Active, not recruiting

Allergic AsthmaPreclinical

Active, not recruiting

Showing 10 of 53 indications

Competition

Competitive Landscape

259 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Empliciti

Bristol-Myers Squibb

Phase 3

43 2

Singulair

OOrganon and Co

Approved

5 3

Venclexta

AbbVie

Phase 3

17 4

Opdivo

Bristol-Myers Squibb

Phase 3

11 5

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

28 6

Treanda

AAzurity Pharmaceuticals

Phase 3

19 7

Neulasta

Amgen

Phase 3

5 8

Vepesid

AAvyxa

Phase 3

17 9

Cytosar

Teva

Phase 3

4 10

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2/3Recruiting

Montelukast

NCT06747130

Phase 2Active, not recruiting

Multiple Myeloma

NCT04268498

Q2 2027

ApprovedRecruiting

Albuminuria

NCT05498116

Phase 3Recruiting

Montelukast

NCT07320625

Phase 1Recruiting

Anterior Cruciate Ligament Reconstruction

NCT04572256

Q3 2027

Phase 2Active, not recruiting

Plasma Cell Myeloma

NCT06356571

Clinical

Trials by Indication[1]

Asthma50 trials

Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Completed·JJohann Wolfgang Goethe University Hospital·Phase 2·NCT00543686·100 enrolled

TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)

Completed·PPharmEvo Pvt Ltd·Phase 4·NCT03096327·180 enrolled

Montelukast Back to School Asthma Study (0476-340)

Completed·OOrganon and Co·Phase 3·NCT00461032·1,162 enrolled

Show 47 more trials

Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

Completed·HHal C Charles·Phase 1·NCT01621386·34 enrolled

Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma

Completed·PPharmaKing·Phase 1·NCT02029313·40 enrolled

Effect of Montelukast on the Expression and Variation of TGF-β for Children With Mild Persistent Asthma

Completed·SShanghai Jiao Tong University School of Medicine··NCT00536705·112 enrolled

A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

Completed·OOno Pharma USA Inc·Phase 2·NCT01536041·59 enrolled

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

Unknown status·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT01404013·99 enrolled

Effects of Montelukast on Airway Regulatory T Cells in Asthma

Unknown status·KKurume University·Phase 2/3·NCT01951898·15 enrolled

BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01103349·243 enrolled

Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)

Completed·OOrganon and Co·Phase 4·NCT00394355·566 enrolled

Change of Airway Hyperresponsiveness to Mannitol and Methacholine in Patients With Asthma

Completed·CCantonal Hosptal, Baselland·Phase 4·NCT01725360·17 enrolled

Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

Completed· GSK logo

GSK·Phase 2·NCT01156792·162 enrolled

Ramatroban/Montelukast Versus Montelukast/Placebo on the Early Allergic Reaction in Asthma Sensitive to House Dust Mite

Withdrawn·RResearch Center Borstel·Phase 2/3·NCT00311051

Management of Asthma in School-age Children on Therapy

Completed·PProfessor Warren Lenney·Phase 4·NCT01526161·229 enrolled

Effect of Montelukast on Remodelling Markers in Asthmatic Children

Completed·UUniversita di Verona·Phase 4·NCT00875082·30 enrolled

The Effects of Montelukast on Smokers With Asthma

Completed·IInje University·Phase 4·NCT00712335·105 enrolled

A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00856687·12 enrolled

A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

Completed·OOrganon and Co·Phase 3·NCT00700661·500 enrolled

Predicting the Response to Montelukast by Genetic Variation in Asthmatics

Completed·—·Phase 3·NCT00116324·150 enrolled

Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma

Completed·MMedical University of Lodz·Phase 4·NCT00490243·150 enrolled

Roflumilast Plus Montelukast in Adults With Severe Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01765192·64 enrolled

A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma

Completed·PPulmagen Therapeutics·Phase 2·NCT01730027·248 enrolled

Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

Completed·SSK Chemicals Co., Ltd.·Phase 2·NCT00936624·245 enrolled

Dose Finding Study for QAW039 in Asthma

Completed· Novartis logo

Novartis·Phase 2·NCT01437735·1,043 enrolled

Montelukast and Loratadine in Children With Asthma

Completed·IInnovacion y Desarrollo de Estrategias en Salud·Phase 3·NCT03372473·80 enrolled

Asthma in the Elderly: The Effect of Montelukast

Completed·RRohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.·Phase 4·NCT02635334·26 enrolled

Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

Completed· GSK logo

GSK··NCT01328964·9,906 enrolled

Acute Montelukast in Asthma

Completed·UUniversity of East Anglia·Phase 4·NCT01011452·87 enrolled

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

Terminated·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT01224964·1 enrolled

A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT01241422·22 enrolled

Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children

Completed·—·Phase 3·NCT00565955·116 enrolled

Trial of Asthma Patient Education (TAPE)

Completed·—·Phase 4·NCT00148408·600 enrolled

Moderate to Persistent Asthma in the Obese Subject

Terminated·—·Phase 4·NCT01016847·38 enrolled

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

Completed·UUniversity of Wisconsin, Madison·N/A·NCT00359073·25 enrolled

Short- and Long Term Growth in Children With Asthma

Completed·CChildren´s Clinic, Randers·Phase 4·NCT00380484·52 enrolled

A Mechanistic Study to Evaluate the Efficacy of Montelukast on Airway Function in Asthma

Unknown status·KKarolinska University Hospital·N/A·NCT01841164·14 enrolled

A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma

Completed·OOno Pharma USA Inc·Phase 2·NCT01551147·25 enrolled

A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT01656395·576 enrolled

Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT02720081·142 enrolled

Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT02761252·454 enrolled

Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)

Withdrawn·OOrganon and Co·Phase 2·NCT01615874

Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)

Completed·OOrganon and Co·Phase 4·NCT00092092·71 enrolled

Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01624974·107 enrolled

Montelukast in Modulating Exacerbations of Asthma in Children

Completed·FFirestone Institute for Respiratory Health·Phase 4·NCT00196547·200 enrolled

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

Completed·OOrganon and Co·Phase 1·NCT00636207·46 enrolled

Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma

Completed· GSK logo

GSK·Phase 3·NCT02483975·111 enrolled

Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year

Completed· GSK logo

GSK·Phase 4·NCT02889809·477 enrolled

Individualized Therapy For Asthma in Toddlers

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT01606306·300 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Completed· Roche logo

Roche·Phase 3·NCT02104674·313 enrolled

Montelukast24 trials

Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01659931·34 enrolled

Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients

Recruiting·PPhramongkutklao College of Medicine and Hospital·Phase 2/3·NCT06747130·82 enrolled

Efficacy of Montelukast on STEMl Patients

Recruiting·SShanghai Zhongshan Hospital·Phase 3·NCT07320625·512 enrolled

Show 21 more trials

Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)

Completed·OOrganon and Co·Phase 4·NCT00756418·84 enrolled

Time-Effect of Montelukast Protection

Completed·UUniversita di Verona·Phase 4·NCT00935415·69 enrolled

Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast

Completed·UUniversity of East Anglia·Phase 2·NCT00947453·15 enrolled

Montelukast as a Controller of Atopic Syndrome

Completed·UUniversity of Helsinki·Phase 4·NCT00559546·61 enrolled

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Completed·DDeborah Gentile·Phase 4·NCT00189475·84 enrolled

The Effect of Montelukast Treatment in Wheezy Infants

Completed·UUniversity of Helsinki·Phase 4·NCT00934713·112 enrolled

Montelukast for Postinfectious Cough

Unknown status·—·Phase 2·NCT02352545·200 enrolled

Montelukast in Very Low Birthweight Infants

Completed·—·Phase 1·NCT00492102·9 enrolled

Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01659918·35 enrolled

Effect of Montelukast in Preventing Dengue With Warning Signs in Dengue Patients

Completed·PPhramongkutklao College of Medicine and Hospital·Phase 2/3·NCT04673422·358 enrolled

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01659905·35 enrolled

Montelukast for Persistent Cough in Young People and Adults

Unknown status·UUniversity of Oxford·Phase 4·NCT01279668·276 enrolled

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01659892·36 enrolled

Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

Completed· GSK logo

GSK·Phase 3·NCT00328718·526 enrolled

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Not yet recruiting·UUniversity of South Florida·Phase 1·NCT06887673·56 enrolled

Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans

Completed·—·Phase 2·NCT04374981·24 enrolled

Bioequivalence Study of Montelukast 5 mg Chewable

Completed· GSK logo

GSK·Phase 1·NCT01863654·32 enrolled

The Population Pharmacokinetics of Montelukast in Infants and Children

Unknown status·SShandong University··NCT03238560·100 enrolled

Bioequivalence Study of Montelukast 10 mg Tablets

Completed· GSK logo

GSK·Phase 1·NCT01943942·32 enrolled

Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions

Completed·UUniversity of California, San Francisco·Phase 2·NCT04198623·40 enrolled

Investigation to Identify Predictors of Response to a Treatment With Montelukast

Completed·—·Phase 4·NCT00721240·50 enrolled

Allergic Rhinitis13 trials

Study Of Patients With Allergic Rhinitis And Asthma

Completed· GSK logo

GSK·Phase 4·NCT00296530·600 enrolled

Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Unknown status·SShiraz University of Medical Sciences·N/A·NCT04561687·66 enrolled

Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT01640535·283 enrolled

Show 10 more trials

A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure Chamber

Completed· Novartis logo

Novartis·Phase 2·NCT01804400·188 enrolled

The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

Terminated·UUniversity of Chicago·Phase 4·NCT00119015·102 enrolled

Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

Unknown status·MMedical University of Lodz·Phase 4·NCT00488176·116 enrolled

Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)

Completed·OOrganon and Co·Phase 3·NCT01852812·87 enrolled

Role of Montelukast in Asthma and Allergic Rhinitis Patients

Completed·CClinision·Phase 4·NCT03380975·600 enrolled

Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

Unknown status·—·Phase 1·NCT05381207·60 enrolled

Study Of Allergic Rhinitis In Patients Who Also Have Asthma

Completed· GSK logo

GSK·Phase 4·NCT00296491·725 enrolled

Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

Active, not recruiting·HHouse Ear Institute·Phase 4·NCT04815187·39 enrolled

Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

Completed·IIndira Gandhi Medical College, Shimla·Phase 4·NCT02551536·70 enrolled

The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)

Completed·OOrganon and Co·Phase 3·NCT00092118·1,992 enrolled

COVID-196 trials

Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:

Terminated·FFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·Phase 3·NCT04695704·86 enrolled

Montelukast - a Treatment Choice for COVID-19

Completed·UUniversity of Sargodha··NCT04714515·150 enrolled

ACTIV-6: COVID-19 Study of Repurposed Medications

Completed·—·Phase 3·NCT04885530·10,956 enrolled

Show 3 more trials

Investigation the Effect of Montelukast in COVID-19

Unknown status·—·Phase 2·NCT04718285·380 enrolled

The Covid-19 Outpatient Symptom Montelukast Oximetry Trial

Unknown status·MMcGill University·Phase 2/3·NCT04389411·250 enrolled

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)

Completed·—·Phase 3·NCT05894577·1,453 enrolled

Multiple Myeloma5 trials

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

Recruiting·—·Phase 2·NCT05896228·30 enrolled

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

Active, not recruiting·UUniversity of Miami·Phase 2·NCT04268498·310 enrolled

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT05704049·118 enrolled

Show 2 more trials

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01998971·240 enrolled

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

Recruiting·EEmory University·Approved·NCT07101445·94 enrolled

68 more indications

Interaction4 trials

Drug-Drug Interaction Study: ASP2151 and Montelukast

Completed·MMaruho Europe Limited·Phase 1·NCT02321748·24 enrolled

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT04425902·20 enrolled

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02227173·20 enrolled

Show 1 more trial

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05852769·18 enrolled

Obstructive Sleep Apnea4 trials

Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

Withdrawn·UUniversity of Louisville·Phase 2·NCT00599534

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

Terminated·UUniversity of Chicago·Phase 4·NCT01027806·64 enrolled

Montelukast for Patients With Obstructive Sleep Apnea Syndrome

Terminated·UUniversity Hospital, Grenoble·Phase 3·NCT03545997·1 enrolled

Show 1 more trial

Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

Completed·UUniversity of Bologna·Phase 4·NCT00912171·45 enrolled

Chronic Cough3 trials

The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity

Completed·IIsala·Phase 4·NCT00453765·89 enrolled

Open-label Study of the Effects of Montelukast in Patients With Chronic Cough

Completed·AAssociation Asthma, Bulgaria·Phase 4·NCT01754220·14 enrolled

The Utility of feNO in the Differential Diagnosis of Chronic Cough

Completed·HHull University Teaching Hospitals NHS Trust·Phase 4·NCT02479074·49 enrolled

Seasonal Allergic Rhinitis3 trials

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

Completed· UCB logo

UCB·Phase 4·NCT00295022·418 enrolled

Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01007721·146 enrolled

Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)

Completed·OOrganon and Co·Phase 3·NCT01857063·220 enrolled

Status Asthmaticus3 trials

Montelukast With Status Asthmaticus, Ages 6-18

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2/3·NCT00494572·52 enrolled

Montelukast With Status Asthmaticus, Ages 2-5

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2/3·NCT00491790·52 enrolled

Evaluation Montelukast in the Treatment of Status Asthmaticus

Unknown status·CCorrie Fletcher·N/A·NCT01770899·100 enrolled

Eosinophilic Esophagitis3 trials

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Withdrawn·MMedical College of Wisconsin·Phase 3·NCT01702701

Trial of Montelukast in Eosinophilic Esophagitis

Completed·MMayo Clinic·Phase 1·NCT00511316·41 enrolled

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

Terminated·—·N/A·NCT01458418·4 enrolled

Atopic Dermatitis2 trials

Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?

Completed·MMurdoch Childrens Research Institute·Phase 4·NCT02534467·60 enrolled

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

Completed·—·Phase 4·NCT00557284·20 enrolled

Concentration2 trials

Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough

Unknown status·—·N/A·NCT02303600·200 enrolled

Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough

Suspended·—·Phase 4·NCT02655562·200 enrolled

Bronchiolitis Obliterans2 trials

Montelukast in Bronchiolitis Obliterans Syndrome

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01211509·30 enrolled

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting·—·Phase 2·NCT05922761·45 enrolled

Wheezing2 trials

Montelukast in Children With Wheezing

Unknown status·UUniversita di Verona·Phase 4·NCT00775697·40 enrolled

Montelukast for Early Life Wheezing

Completed·UUniversity of Massachusetts, Worcester·Phase 2/3·NCT00115297·62 enrolled

Acute Bronchiolitis2 trials

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

Completed·HHormozgan University of Medical Sciences·N/A·NCT01370187·146 enrolled

Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis

Recruiting·PPakistan Institute of Medical Sciences·Phase 2·NCT07770464·60 enrolled

Treatment2 trials

Medical vs Surgical Treatment in OSA Among Children

Unknown status·—·Phase 4·NCT05651750·90 enrolled

Wheeze and Intermittent Treatment

Completed·QQueen Mary University of London·Phase 3·NCT01142505·1,358 enrolled

Plasma Cell Myeloma2 trials

A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT06356571·64 enrolled

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT05405166·531 enrolled

Multiple Sclerosis1 trial

Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera

Completed· Biogen logo

Biogen·Phase 4·NCT02410278·102 enrolled

Prospective1 trial

A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

Completed· Sanofi logo

Sanofi·Phase 4·NCT06019728·8 enrolled

Drug Interactions1 trial

CYP2B6 Genetics and Drug Interactions in Healthy Volunteers

Completed·IIndiana University·Phase 4·NCT02401256·70 enrolled

Endothelial Dysfunction1 trial

Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?

Completed·—·N/A·NCT00814281·24 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions

Completed·PPharmtechnology LLC·Phase 1·NCT03898193·34 enrolled

Tonsillectomy1 trial

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

Completed·—·Phase 3·NCT02793375·117 enrolled

Children1 trial

Exercise Induced Bronchospasm in Children

Completed·UUniversity of New Mexico·Phase 4·NCT00273689·13 enrolled

Bronchopulmonary Dysplasia1 trial

The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia

Completed·—·Phase 2·NCT01717625·72 enrolled

Food Allergy1 trial

Effects of Montelukast in Asthmatic Children With and Without Food Allergy

Completed·HHacettepe University·Phase 4·NCT01618929·113 enrolled

Respiratory tract infection1 trial

Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

Terminated·MMaisonneuve-Rosemont Hospital·Phase 2·NCT01432080·12 enrolled

Bronchitis1 trial

Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis

Unknown status·GGuangzhou Medical University·Phase 4·NCT01121016·63 enrolled

Otitis Media With Effusion1 trial

Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT01967498·52 enrolled

Chronic Periodontitis1 trial

Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

Completed·TTatyasaheb Kore Dental College·Phase 4·NCT02014532·60 enrolled

Combination Therapy1 trial

Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction

Completed·HHamilton Health Sciences Corporation·Phase 3·NCT00462592·18 enrolled

Drug Repurposing1 trial

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

Completed·—··NCT05457855·51,533 enrolled

Chronic Rhinosinusitis With Nasal Polyps1 trial

Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

Unknown status·—·Phase 1/2·NCT05143502·60 enrolled

Idiopathic Nephrotic Syndrome1 trial

Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Completed·NNishtar Medical University·N/A·NCT04818723·106 enrolled

Inflammatory Response1 trial

Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Unknown status·SSoroka University Medical Center·Phase 4·NCT00299910·50 enrolled

Rhinitis1 trial

The Role of Montelukast in Rhinitis and Sleep

Completed·PPenn State University·Phase 4·NCT00590772·31 enrolled

Cardiotoxicity1 trial

Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

Completed·—·N/A·NCT05959889·50 enrolled

Hepatitis1 trial

Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)

Completed·TTanta University·Phase 4·NCT04537780·44 enrolled

Preterm Birth1 trial

Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth

Unknown status·UUniversité de Sherbrooke·Phase 2·NCT02108886·100 enrolled

Acute otitis media1 trial

A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

Completed·DDeborah Gentile·Phase 4·NCT00189462·99 enrolled

Sickle Cell Disease1 trial

SMILES: Study of Montelukast in Sickle Cell Disease

Unknown status·GGreat Ormond Street Hospital for Children NHS Foundation Trust·Phase 2/3·NCT04351698·200 enrolled

Atopic Asthma1 trial

The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics

Completed·NNorthwell Health·N/A·NCT01329939·26 enrolled

Prognosis1 trial

Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis

Unknown status·SSun Yat-sen University··NCT02505113·150 enrolled

Bronchiolitis1 trial

Montelukast in Acute RSV Bronchiolitis

Completed·ZZiv Hospital·N/A·NCT00524693·51 enrolled

Heart Disease1 trial

Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

Completed·UUniversity of Florida·N/A·NCT00379808·22 enrolled

Eosinophilia1 trial

Montelukast in the Treatment of Duodenal Eosinophilia

Completed·—·N/A·NCT00148603·24 enrolled

Methotrexate1 trial

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03131973·26 enrolled

Drug1 trial

Effect of Some Drugs on Rheumatoid Arithritis Activity

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT03770923·75 enrolled

Pruritus1 trial

Montelukast for Treatment of Uremic Pruritus

Completed·SShiraz University of Medical Sciences·N/A·NCT02559388·73 enrolled

Atherosclerosis1 trial

Air Pollution (PM2.5) on Accelerated Atherosclerosis: A Montelukast Interventional Study in Modernizing China

Unknown status·—·Phase 4·NCT04762472·200 enrolled

Atopic1 trial

Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

Completed·MMitchell Grayson·N/A·NCT03039101·25 enrolled

Efficacy and Safety1 trial

Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily

Completed· GSK logo

GSK·Phase 2·NCT01147744·700 enrolled

Type 2 Diabetes Mellitus1 trial

Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus

Completed·SSadat City University·Phase 1·NCT04075110·100 enrolled

Corticosteroids1 trial

Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness

Completed·HHvidovre University Hospital·Phase 4·NCT00913328·31 enrolled

Peripheral Arterial Disease1 trial

Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease

Unknown status·JJagiellonian University·Phase 3·NCT04277702·200 enrolled

Acne Vulgaris1 trial

Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast

Not yet recruiting·SSouth Valley University·Phase 3·NCT06340984·60 enrolled

Pilot Study1 trial

A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial

Completed·UUniversity of California, San Diego·Phase 4·NCT01696214·20 enrolled

Salmeterol1 trial

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Completed·JJHSPH Center for Clinical Trials·Phase 4·NCT00156819·500 enrolled

Rheumatoid Arthritis1 trial

Montelukast Use in Rheumatoid Arthritis

Completed·NNoha Mansour·Phase 2·NCT05447520·92 enrolled

Chronic Graft Versus Host Disease1 trial

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT04294641·10 enrolled

Anterior Cruciate Ligament Reconstruction1 trial

MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

Recruiting·AAustin V Stone·Phase 1·NCT04572256·30 enrolled

Non-Allergic Rhinitis1 trial

Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)

Unknown status·—·Phase 4·NCT00406094·6 enrolled

Chronic Rhinosinusitis1 trial

Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery

Completed·FFirst Affiliated Hospital, Sun Yat-Sen University·Phase 4·NCT02110654·50 enrolled

Kidney Disease1 trial

Targeting Leukotrienes in Kidney Disease

Terminated·UUniversity of Colorado, Denver·Phase 3·NCT05362474·6 enrolled

Alzheimer's Disease1 trial

Montelukast Therapy on Alzheimer's Disease

Completed·EEmory University·Phase 2·NCT03991988·32 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05663866·68 enrolled

Type 2 Diabetes1 trial

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT07409714·50 enrolled

Parkinson disease1 trial

Clinical Study to Investigate the Possible Efficacy and Safety of Montleukast in Parkinson Disease

Completed·MMostafa Bahaa·Preclinical·NCT06113640·60 enrolled

Gulf War Syndrome1 trial

Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness (GWI)

Recruiting·BBaylor College of Medicine·Phase 1·NCT05992311·80 enrolled

Diabetes1 trial

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Not yet recruiting·UUniversity of Colorado, Denver·Approved·NCT07685886·110 enrolled

Albuminuria1 trial

Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Recruiting·UUniversity of Colorado, Denver·Approved·NCT05498116·50 enrolled

Unspecified1 trial

A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Embibatinib, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of Embibatinib.

Completed·TTerns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·Phase 1·NCT07838987·196 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 20, 1998

SINGULAIR

NDA NDA020829

Mar 3, 2000

SINGULAIR

NDA NDA020830

Jul 26, 2002

SINGULAIR

NDA NDA021409

Sources

References

[1]
ClinicalTrials.gov — 187 trial records for Montelukast. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Singulair drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Montelukast compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Montelukast. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021409). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cysteinyl Leukotriene Receptor 1 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOrganon and Co