Montelukast: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Montelukast appears in the FDA drug-label database. Marketed as Montelukast.
- Boxed warning
- The FDA label for Montelukast carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
& USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. 1.3 Allergic Rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. — Hetero Labs Limited Unit V | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-08-20 |
| Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product — Macleods Pharma Usa Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2020-01-20 |
| Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg. — Dr. Reddy's Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-10-13 |
| Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg. — Hetero Labs Limited Unit V | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2018-08-15 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| ACL Injury | 1 |
| Meniscus Tear | 1 |
| Osteoarthritis | 1 |
| Post-traumatic Osteoarthritis | 1 |
| Rheumatoid Arthritis | 1 |
| Type 2 Diabetes | 1 |
Recruiting trials involving Montelukast
- Effect of Some Drugs on Rheumatoid Arithritis Activity
- MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
- SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
Common questions
Is Montelukast FDA-approved?
Yes, marketed as Montelukast. Its FDA label carries a boxed warning.
How many recruiting trials involve Montelukast?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.