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Salmeterol/fluticasone Diskus

Salmeterol/fluticasone Diskus is a Long-acting beta-2 agonist/inhaled corticosteroid combination Small molecule drug developed by AstraZeneca. It is currently FDA-approved for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy. Also known as: Seretide Diskus® 500 mcg Inhalation Powder.

Salmeterol/fluticasone combines a long-acting beta-2 agonist that dilates airways with an inhaled corticosteroid that reduces airway inflammation.

Salmeterol/fluticasone Diskus is a medication used to treat conditions such as Chronic Obstructive Pulmonary Disease and Asthma. It works as a glucocorticoid receptor agonist, a type of small molecule that activates the glucocorticoid receptor.

At a glance

Mechanism of action

Salmeterol is a long-acting beta-2 adrenergic agonist (LABA) that binds to beta-2 receptors on airway smooth muscle, causing bronchodilation and lasting 12 hours. Fluticasone propionate is a potent inhaled corticosteroid that suppresses airway inflammation by binding glucocorticoid receptors, reducing mucus production and airway hyperresponsiveness. Together, they provide both immediate and sustained relief of airway obstruction while controlling underlying inflammatory pathology.

Approved indications

• Asthma maintenance therapy
• Chronic obstructive pulmonary disease (COPD) maintenance therapy

Common side effects

• Tremor
• Headache
• Palpitations
• Muscle cramps
• Oral candidiasis
• Hoarseness
• Nervousness/anxiety

Key clinical trials

• Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1) (PHASE3)
• Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID (PHASE4)
• Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus® (PHASE3)
• Mechanism(s) of Airflow Limitation During Exacerbation of Asthma (PHASE4)
• Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
• Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
• Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
• Bioequivalence With Clinical Endpoint Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Salmeterol/fluticasone Diskus CI brief — competitive landscape report
• Salmeterol/fluticasone Diskus updates RSS · CI watch RSS
• AstraZeneca portfolio CI

Frequently asked questions about Salmeterol/fluticasone Diskus

Related

• Drug class: All Long-acting beta-2 agonist/inhaled corticosteroid combination drugs
• Target: All drugs targeting Beta-2 adrenergic receptor; glucocorticoid receptor
• Manufacturer: AstraZeneca — full pipeline
• Therapeutic area: All drugs in Respiratory/Pulmonology
• Indication: Drugs for Asthma maintenance therapy
• Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
• Also known as: Seretide Diskus® 500 mcg Inhalation Powder

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing