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Singulair

(Montelukast Sodium)

ApprovedSmall molecule

Montelukast is used to prevent and treat asthma symptoms and to relieve nasal congestion from allergies. It works by blocking substances in the body that cause inflammation and narrowing of airways.[2] Singulair is currently approved and in use across 16 indications[4].[1]

Singulair is one of 322 small molecule programs targeting Bronchiolitis Obliterans. It is currently in Approved.

16

Indications

48

Total Trials

0

Active Trials

321

Competitors

Pipeline

Status by Indication[4][1]

Indication

Bronchiolitis ObliteransActive, not recruiting

BronchiolitisActive, not recruiting

Neonatal SepsisActive, not recruiting

Acute BronchiolitisActive, not recruiting

Chronic AsthmaActive, not recruiting

Rhinitis, Allergic, PerennialUnknown

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

BronchitisActive, not recruiting

SepsisActive, not recruiting

Allergic RhinitisUnknown

Bronchiolitis ObliteransPhase 2

Active, not recruiting

BronchiolitisPhase 3

Active, not recruiting

Neonatal SepsisPhase 1

Active, not recruiting

Acute BronchiolitisPreclinical

Active, not recruiting

Chronic AsthmaPhase 3

Active, not recruiting

Rhinitis, Allergic, PerennialPreclinical

Unknown

Chronic Obstructive Pulmonary DiseasePhase 3

Active, not recruiting

BronchitisApproved

Active, not recruiting

SepsisPhase 2/Phase 3

Active, not recruiting

Allergic RhinitisPreclinical

Unknown

Showing 10 of 16 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Singulair

Spikevax

Aquasol E

NNational Eye Institute (NEI)

SARS-COV-2 VACCINE

Statin

Bristol-Myers Squibb

Piperacillin/tazobactam

Selenium

SSWOG Cancer Research Network

Biological Collection

AAssistance Publique - Hôpitaux de Paris

DAS181

AAnsun Biopharma, Inc.

Exoflo

DDirect Biologics, LLC

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

Clinical

Trials by Indication[1]

Asthma17 trials

Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

Completed·OOrganon and Co·Phase 3·NCT00127166·154 enrolled

Effects of Montelukast in Children With Asthma

Completed·—·Phase 3·NCT00675285·26 enrolled

MK0476 Study in Adult Patients With Acute Asthma (0476-322)

Completed·OOrganon and Co·Phase 3·NCT00229970·225 enrolled

Show 14 more trials

The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)

Completed·OOrganon and Co·Phase 3·NCT00755794·800 enrolled

Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

Completed·OOrganon and Co·N/A·NCT00943683·256 enrolled

Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

Completed·OOrganon and Co·Phase 4·NCT00832455·445 enrolled

Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

Completed·OOrganon and Co·Phase 3·NCT00442338·91 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

The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

Completed·OOrganon and Co·Phase 3·NCT00911547·642 enrolled

Effect of Montelukast in Asthma in Children

Unknown status·MMedical University of Lodz·Phase 3·NCT01266772·160 enrolled

A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)

Completed·OOrganon and Co·Phase 3·NCT00117338·276 enrolled

Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288)

Completed·OOrganon and Co·Phase 3·NCT00092989·650 enrolled

Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00337675·1,771 enrolled

Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00284856·1,640 enrolled

Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)

Completed·UUniversity of Brasilia·Phase 4·NCT00770900·83 enrolled

Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma

Unknown status·MMedical University of Lodz·Phase 2·NCT00961155·200 enrolled

Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma

Completed·MMedical University of Lodz·Phase 4·NCT00487773·96 enrolled

Allergic Rhinitis5 trials

An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Completed·OOrganon and Co·Phase 3·NCT00127647·1,375 enrolled

Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Completed·OOrganon and Co·Phase 3·NCT00974571·1,365 enrolled

Singulair(R) In Asthma And Allergic Rhinitis (0476-383)

Completed·OOrganon and Co·Phase 4·NCT00545844·313 enrolled

Show 2 more trials

MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00771160·120 enrolled

Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

Completed·OOrganon and Co·Phase 4·NCT00442559·191 enrolled

Montelukast4 trials

Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition

Completed·—·Phase 1·NCT01691456·45 enrolled

Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition

Completed·—·Phase 1·NCT01671722·43 enrolled

Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition

Completed·—·Phase 1·NCT01691469·31 enrolled

Show 1 more trial

Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition

Completed·—·Phase 1·NCT01671709·41 enrolled

Seasonal Allergic Rhinitis4 trials

A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00968149·413 enrolled

A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00960141·829 enrolled

Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

Completed·OOrganon and Co·Phase 3·NCT00972738·1,214 enrolled

Show 1 more trial

Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

Completed·OOrganon and Co·Phase 3·NCT00963469·1,079 enrolled

Chronic Asthma3 trials

Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

Completed·OOrganon and Co·Phase 3·NCT00943397·190 enrolled

Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

Completed·OOrganon and Co·Phase 3·NCT00968201·689 enrolled

A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

Withdrawn·OOrganon and Co·Phase 3·NCT00540839

14 more indications

Sepsis2 trials

Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants

Completed·MMansoura University Children Hospital·Phase 1·NCT04474327·40 enrolled

Effect of Montelukast Versus Co Enzyme in Sepsis

Completed·—·Phase 2/3·NCT05293132·90 enrolled

Exercise1 trial

Exercise Induced Bronchoconstriction (0476-359)

Completed·OOrganon and Co·Phase 1·NCT00664937·24 enrolled

Immunotherapy1 trial

Pharmacological Modulations of Allergen-Specific Immunotherapy

Completed·MMedical University of Lodz·Phase 3·NCT00504946·85 enrolled

Acute Bronchiolitis1 trial

Trial of Montelukast for Treatment of Acute Bronchiolitis

Completed·MMedical College of Wisconsin·N/A·NCT00863317·141 enrolled

Chronic Obstructive Pulmonary Disease1 trial

A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease

Completed·KKaiser Permanente·Phase 3·NCT00162864·200 enrolled

Heart Disease1 trial

Does Montelukast Have an Affect on the Function of the Artery in Patients With Heart Disease

Terminated·UUniversity of Calgary·Phase 4·NCT00351364·40 enrolled

Preoperative1 trial

Preoperative Use of Montelukast Sodium

Completed·UUmraniye Education and Research Hospital·Phase 4·NCT02494466·30 enrolled

Interaction1 trial

A Drug Interaction Study of Montelukast and Levocetirizine

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 1·NCT01491503·30 enrolled

Bronchiolitis Obliterans1 trial

Targeted Therapy of Bronchiolitis Obliterans Syndrome

Completed·SStephanie Lee·Phase 2·NCT01307462·36 enrolled

Bronchiolitis1 trial

An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

Completed·OOrganon and Co·Phase 3·NCT00076973·1,125 enrolled

Allergic Asthma1 trial

Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00289874·421 enrolled

Budesonide1 trial

Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641472·380 enrolled

COVID-191 trial

Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough

Completed·—·N/A·NCT05447039·64 enrolled

Bronchitis1 trial

Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis

Unknown status·SSamarkand State Medical Institute·Phase 4·NCT04613180·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Montelukast Sodium. 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 Sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Montelukast Sodium. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — AstraZeneca 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: AstraZeneca

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