SINGULAIR (montelukast sodium) · Merck
Singulair is a leukotriene receptor antagonist indicated for the prophylaxis and chronic treatment of asthma in patients 12 months of age and older. It is also indicated for the prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. For allergic rhinitis, it is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years and older and perennial allergic rhinitis in patients 6 months and older. Due to the risk of neuropsychiatric events, use for allergic rhinitis should be reserved for patients who have an inadequate response or intolerance to alternative therapies. Singulair is not indicated for the treatment of acute asthma attacks.
How SINGULAIR Works
Montelukast is an orally active compound that binds with high affinity and selectivity to the cysteinyl leukotriene type-1 (CysLT1) receptor, specifically inhibiting the physiologic actions of leukotriene D4 (LTD4). Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are eicosanoids released from cells such as mast cells and eosinophils that bind to CysLT receptors in the airway and nasal mucosa. By blocking these receptors, montelukast inhibits leukotriene-mediated effects including airway edema, smooth muscle contraction, and inflammatory cellular activity associated with the pathophysiology of asthma and allergic rhinitis.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1998-02-20
- Revenue
- $240M (Q4-2016)
- Routes
- ORAL
- Dosage Forms
- GRANULE, TABLET, TABLET, CHEWABLE
SINGULAIR Approval History
What SINGULAIR Treats
3 indicationsSINGULAIR is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Exercise-Induced Bronchoconstriction
- Allergic Rhinitis
SINGULAIR Boxed Warning
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood [see Warnings and Precautions (5.1) ] . Because of the risk of NP events, the benefits o...
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood [see Warnings and Precautions (5.1) ] . Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3) ] . In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR. Discuss the benefits and risks of SINGULAIR with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking SINGULAIR. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue SINGULAIR and contact a healthcare provider immediately [see Warnings and Precautions (5.1) ] . WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS See full prescribing information for complete boxed warning. Serious neuropsychiatric events have been reported in patients taking SINGULAIR ( 5.1 ). Discuss benefits and risks of SINGULAIR with patients and caregivers ( 5.1 ). Monitor for neuropsychiatric symptoms in patients taking SINGULAIR ( 5.1 ). Discontinue SINGULAIR immediately if neuropsychiatric symptoms occur ( 5.1 ). Because the benefits of SINGULAIR may not outweigh the potential risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who ha
SINGULAIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SINGULAIR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04474327 | Montelukast in neonatal sepsis | Ph 1 | completed | Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants |
| NCT03898193 | FRM-07-MONT v.2.1 01/29/2019 | Ph 1 | completed | Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions |
| NCT01307462 FAM for BOS results posted | 2367.00 NCI-2011-00203, U54CA163438 | Ph 2 | completed | Targeted Therapy of Bronchiolitis Obliterans Syndrome |
| NCT02494466 | GK6 | Ph 4 | completed | Preoperative Use of Montelukast Sodium |
| NCT02480049 | GRC/1/14/523 | Ph 1 | completed | A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck) |
| NCT02479854 | GRC/1/14/520 | Ph 1 | completed | Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck) |
| NCT02029313 | PMK-M01RS1 | Ph 1 | completed | Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma |
| NCT01424124 | YHD001-201 | Ph 2 | completed | Safety and Efficacy of YHD001 in Asthma |
| NCT01491503 MOLZ | HM-MOLZ-101 | Ph 1 | completed | A Drug Interaction Study of Montelukast and Levocetirizine |
| NCT01691469 | 540-10 | Ph 1 | completed | Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition |
| NCT01691456 | 539-10 | Ph 1 | completed | Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition |
| NCT01671709 | 615/10 | Ph 1 | completed | Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition |
| NCT01671722 | 616/10 | Ph 1 | completed | Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition |
| NCT00770900 | 2008_563 MK0476-403 | Ph 4 | completed | Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SINGULAIR FDA Label Details
Indications & Usage
FDA Label (PDF)SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older . Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older . 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 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies . Limitations of Use: Not indicated to treat an acute asthma...
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior ...
Pro Intelligence Preview
Deep insights for SINGULAIR
Revenue Insights
- • Q4-2016: $240M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 14 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment