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Montelukast Oral Granules
At a glance
| Generic name | Montelukast Oral Granules |
|---|---|
| Also known as | Singulair, Fluticasone Furoate nasal spary, Montelukast (active), Montelukast Placebo (control) |
| Sponsor | Vanderbilt University Medical Center |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia (PHASE1, PHASE2)
- A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme (PHASE4)
- Treating Exacerbations of Asthma With Oral Montelukast in Children (PHASE2)
- Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations (PHASE2)
- Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297) (PHASE2)
- PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED) (PHASE2)
- Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520) (PHASE3)
- A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Montelukast Oral Granules CI brief — competitive landscape report
- Montelukast Oral Granules updates RSS · CI watch RSS
- Vanderbilt University Medical Center portfolio CI