montelukast
montelukast: developed by 2 companies · 9 clinical trials tracked · 5 FDA decisions.
montelukast evidence translation
What we can confirm
5 FDA records · 9 tracked trials
What it means
What to watch
Prepared research question
What is verified about montelukast, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 3 study sponsors
Development Pipeline (2)
| Company | Phase |
|---|---|
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
| Teva Pharmaceutical Industries Limited (TEVA) | Approved |
Clinical Trials (9)
Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)
Primary endpoint: Incidence and severity of systemic reactions
A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Primary endpoint: Overall response rate (ORR)
An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation
Primary endpoint: 24-week Overall Response Rate (ORR) [Cohort A]
Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma
Primary endpoint: Rate of MRD-negativity: Iber-KDd Combination therapy.
A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion
Primary endpoint: Percent Reduction in Shortest Tolerated Infusion Duration From Pre-study Average of Recent 3 Infusions
Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study
Primary endpoint: Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1
A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Primary endpoint: Overall response rate (ORR) - Cohorts 1 to 3
A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Primary endpoint: Overall Response Rate (ORR)
Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Primary endpoint: Rate of Minimal Residual Disease (MRD) Negativity
FDA Decisions5 records
Frequently asked questions
Who is developing montelukast?
montelukast is being developed by DR REDDYS LABORATORIES LTD, Teva Pharmaceutical Industries Limited.
How many clinical trials involve montelukast?
BioSniper tracks 9 clinical trials involving montelukast.
What is montelukast's latest FDA decision?
The most recent tracked FDA decision for montelukast is Approval for 1 INDICATIONS AND USAGE Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years of age and older ( 1.1 ). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age , dated September 17, 2012.