Active Ingredient History
Montelukast (SINGULAIR®) is a selective and orally active leukotriene D4 (LTD4) receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. It is indicated for the prophylaxis and chronic treatment of asthma, for prevention of exercise-induced bronchoconstriction, and for the relief of symptoms of seasonal allergic rhinitis. LTD4 is a product of arachidonic acid metabolism and is released from various cells, including mast cells and eosinophils. This eicosanoid binds to CysLT1 receptor found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). Cysteinyl leukotriene receptors (CysLTs) have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both earlyand late-phase reactions and are associated with symptoms of allergic rhinitis. Montelukast (SINGULAIR®) binds with high affinity and selectivity to the CysLT1 (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or beta-adrenergic receptor). It inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Bronchoconstriction (approved 1998)
Rhinitis, Allergic, Perennial (approved 1998)
Acute Coronary Syndrome (Phase 4)
Aged (Phase 4)
Airway Management (Phase 4)
Alzheimer Disease (Phase 2)
Anemia, Sickle Cell (Phase 2/Phase 3)
Anterior Cruciate Ligament Injuries (Early Phase 1)
Antibodies, Monoclonal (Phase 2)
Arthritis, Rheumatoid (Phase 3)
Asthma ()
Asthma, Exercise-Induced (Phase 4)
Atherosclerosis (Phase 3)
Bronchial Hyperreactivity (Phase 4)
Bronchiolitis (Phase 4)
Bronchiolitis Obliterans (Phase 4)
Bronchitis (Phase 4)
Bronchopulmonary Dysplasia (Phase 2)
Child (Phase 4)
Chronic Limb-Threatening Ischemia (Phase 3)
Chronic Periodontitis (Phase 4)
Conjunctivitis (Phase 4)
Conjunctivitis, Allergic (Phase 4)
Coronary Artery Disease (Phase 4)
Cough (Phase 4)
COVID-19 (Phase 4)
Cryptogenic Organizing Pneumonia (Phase 2)
Deglutition Disorders (Phase 3)
Dengue (Phase 2/Phase 3)
Dengue Virus (Phase 2/Phase 3)
Dermatitis, Atopic (Phase 4)
Diabetes Mellitus, Type 2 (Phase 3)
Drug Interactions (Phase 1)
Drugs, Investigational (Phase 2)
Eosinophilic Esophagitis (Phase 3)
Exercise (Phase 4)
Food-Drug Interactions (Phase 2)
Food Hypersensitivity (Phase 4)
Graft Rejection (Phase 4)
Graft vs Host Disease (Phase 2)
Healthy Volunteers (Phase 4)
Hematopoietic Stem Cell Transplantation (Phase 2)
HIV Infections (Phase 1)
Immune System Diseases (Phase 1/Phase 2)
Infant, Very Low Birth Weight (Phase 2)
Infusions, Intravenous (Phase 2)
Leukemia, Myeloid, Acute (Phase 2)
Leukotrienes (Phase 2)
Lung Diseases (Phase 2/Phase 3)
Lung Diseases, Interstitial (Phase 2)
Lung Diseases, Obstructive (Phase 4)
Lung Transplantation (Phase 4)
Meniere Disease (Phase 4)
Meniscus (Early Phase 1)
Multiple Myeloma (Phase 2)
Multiple Sclerosis (Phase 4)
Nasal Polyps (Phase 4)
Neonatal Sepsis (Phase 1)
Neoplasms (Phase 1)
Non-alcoholic Fatty Liver Disease (Phase 4)
Obesity (Early Phase 1)
Obstetric Labor, Premature (Phase 2)
Osteoarthritis (Early Phase 1)
Otitis (Phase 4)
Otitis Media (Phase 4)
Otitis Media with Effusion (Phase 3)
Ovarian Hyperstimulation Syndrome (Phase 2)
Pain (Phase 3)
Peripheral Arterial Disease (Phase 3)
Peripheral Vascular Diseases (Phase 3)
Premature Birth (Phase 2)
Pulmonary Disease, Chronic Obstructive (Phase 3)
Respiratory Sounds (Phase 4)
Respiratory Tract Infections (Phase 4)
Rhinitis (Phase 4)
Rhinitis, Allergic (Phase 4)
Rhinitis, Allergic, Perennial (Phase 4)
SARS-CoV-2 (Phase 2)
Severe Acute Respiratory Syndrome (Phase 3)
Severe Dengue (Phase 2/Phase 3)
Signs and Symptoms, Respiratory (Phase 4)
Sinusitis (Phase 4)
Sleep Apnea, Obstructive (Phase 4)
Sleep Apnea Syndromes (Phase 4)
Status Asthmaticus (Phase 2/Phase 3)
Vertigo (Phase 4)
Whooping Cough (Phase 4)
| Trial | Phase | Start Date | Organizations | Indications |
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