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Diskus Fluticasone/salmeterol
Diskus Fluticasone/salmeterol is a Inhaled corticosteroid/long-acting beta-2 agonist combination Small molecule drug developed by University Medical Center Groningen. It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy. Also known as: Diskus® Fluticasone/salmeterol.
Fluticasone/salmeterol is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and dilates airways to improve breathing.
Fluticasone/salmeterol is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and dilates airways to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Diskus Fluticasone/salmeterol |
|---|---|
| Also known as | Diskus® Fluticasone/salmeterol |
| Sponsor | University Medical Center Groningen |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Fluticasone propionate is a potent inhaled corticosteroid that suppresses inflammatory responses in the airways by binding to glucocorticoid receptors, reducing mucus production and airway edema. Salmeterol is a long-acting beta-2 agonist that binds to beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and lasting up to 12 hours. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness
- Oral candidiasis
- Palpitations
- Muscle cramps
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.
| Source | Used for |
|---|---|
| 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:
- Diskus Fluticasone/salmeterol CI brief — competitive landscape report
- Diskus Fluticasone/salmeterol updates RSS · CI watch RSS
- University Medical Center Groningen portfolio CI
Frequently asked questions about Diskus Fluticasone/salmeterol
What is Diskus Fluticasone/salmeterol?
How does Diskus Fluticasone/salmeterol work?
What is Diskus Fluticasone/salmeterol used for?
Who makes Diskus Fluticasone/salmeterol?
Is Diskus Fluticasone/salmeterol also known as anything else?
What drug class is Diskus Fluticasone/salmeterol in?
What development phase is Diskus Fluticasone/salmeterol in?
What are the side effects of Diskus Fluticasone/salmeterol?
What does Diskus Fluticasone/salmeterol target?
Related
- Drug class: All Inhaled corticosteroid/long-acting beta-2 agonist combination drugs
- Target: All drugs targeting Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol)
- Manufacturer: University Medical Center Groningen — 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: Diskus® Fluticasone/salmeterol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing