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Salmeterol 50 mcg via DISKUS
Salmeterol is a long-acting beta2-adrenergic agonist that relaxes bronchial smooth muscle to improve airflow.
Salmeterol 50 mcg via DISKUS is a long-acting beta2-adrenergic agonist (LABA) developed by GlaxoSmithKline for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles in the airways to improve breathing. Despite its effectiveness, it carries warnings about the risk of asthma-related death when used without an inhaled corticosteroid. Common side effects include upper respiratory tract infections, headache, and muscle pain. The drug has no FDA label, which may affect its market presence and regulatory status.
At a glance
| Generic name | Salmeterol 50 mcg via DISKUS |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Long-acting beta2-adrenergic agonist (LABA) |
| Target | Beta2-adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
Mechanism of action
Salmeterol binds to and activates beta2-adrenergic receptors on bronchial smooth muscle cells, leading to the relaxation of these muscles and improved airflow.
Approved indications
Boxed warnings
- Increased risk of asthma-related death when used without an inhaled corticosteroid
Common side effects
- Upper respiratory tract infection
- Headache
- Muscle pain
- Pharyngitis
- Sinusitis
- Nasal congestion
Drug interactions
- Monoamine oxidase inhibitors (MAOIs)
- Tricyclic antidepressants
Key clinical trials
- Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1) (PHASE3)
- Mechanism(s) of Airflow Limitation During Exacerbation of Asthma (PHASE4)
- Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD (PHASE4)
- MGR001 / Advair Diskus Local Equivalence Study in Asthma (PHASE3)
- A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma (PHASE3)
- Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment (PHASE4)
- A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE4)
- Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg) (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US5541195 |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Salmeterol 50 mcg via DISKUS CI brief — competitive landscape report
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