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Label indication SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). FDA label
Also known as Montelukast sodium, SINGULAIR
Montelukast · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Montelukast Sodium Oral Granules | EXPERIMENTAL | Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited |
| SINGULAIR | ACTIVE_COMPARATOR | (Montelukast sodium) Oral Granules 4mg of Merck Sharp \& Dohme Ltd., USA |
| Montelukast sodium tablets | EXPERIMENTAL | Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited |
| Name | Type | Description |
|---|---|---|
| Montelukast sodium | DRUG | Montelukast Sodium Oral Granules 4mg |
Inclusion Criteria: Subjects must fulfill the following criteria to be considered for inclusion into this study. * Healthy subjects within the age range of 18 to 50 years. * A body mass index between 18.5 to 24.9 Kg/m2 * Given written informed consent to participate in the study. * Absence of dise...
Montelukast is a small molecule drug also known as montelukast sodium. It is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The clinical program listed for this asset is in Phase 1, and the specific therapeutic indication being studied is undisclosed.
Montelukast targets CYSLTR1, where it acts as an antagonist. By blocking this receptor, the drug interferes with signaling through that target. CYSLTR1 antagonism is the mechanism described for this small molecule asset in the Dr. Reddy's Laboratories development program.
Montelukast is developed by Dr. Reddy's Laboratories Ltd, which is publicly listed under the ticker RDY. The company is the sponsor associated with the clinical trials of montelukast sodium oral granules and tablets that appear in this development program.
Montelukast is in Phase 1 clinical development. The program includes four completed Phase 1 trials, and no active trials are currently listed. The studies were randomized and active controlled, with a total enrollment of 160 participants across the program.
Four completed Phase 1 bioequivalence trials are listed for Montelukast: NCT01691469 and NCT01691456 tested oral granules 4 mg under fed and fasting conditions, while NCT01671722 and NCT01671709 tested tablets 10 mg under fed and fasting conditions. All four enrolled healthy volunteers in India.
Yes, montelukast sodium is an alternative name for Montelukast. The clinical trials in this program are listed under the montelukast sodium name, covering oral granules and tablet formulations. Readers searching either term are referring to the same small molecule asset developed by Dr. Reddy's Laboratories.