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SALMETEROL
Fluticasone propionate reduces inflammation, while salmeterol relaxes bronchial muscles and inhibits mediator release.
Salmeterol, in combination with fluticasone propionate, is a marketed drug primarily indicated for asthma treatment. The key strength of this combination lies in its dual mechanism, where fluticasone propionate reduces inflammation and salmeterol relaxes bronchial muscles and inhibits mediator release. A primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | SALMETEROL |
|---|---|
| Target | Glucocorticoid receptor, beta2-adrenoceptors |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1994 |
Mechanism of action
Fluticasone propionate, a corticosteroid, reduces inflammation by affecting various immune cells and mediators involved in asthma. Salmeterol, a long-acting beta2-adrenergic agonist, relaxes bronchial smooth muscles and prevents the release of substances that cause allergic reactions.
Approved indications
- Asthma Treatment
- Asthma Not Adequately Controlled
Common side effects
- Nasopharyngitis
- Nasopharyngitis
- Nasopharyngitis
- Nasopharyngitis
- Nasopharyngitis
- Nasopharyngitis
- Oral candidiasis*
- Oral candidiasis*
- Oral candidiasis*
- Oral candidiasis*
- Oral candidiasis*
- Oral candidiasis*
Drug interactions
- Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole)
- Monoamine oxidase inhibitors and tricyclic antidepressants
- Beta-blockers
- Non-potassium-sparing diuretics
Key clinical trials
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation (NA)
- A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (PHASE3)
- Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma (PHASE4)
- Advair HFA in Healthy and HAPE Predisposed Subjects (PHASE1, PHASE2)
- Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation (PHASE3)
- ANTES B+ Clinical Trial (PHASE4)
- Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion (NA)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- SALMETEROL CI brief — competitive landscape report
- SALMETEROL updates RSS · CI watch RSS