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indacaterol/glycopyrronium 110/50 Breezhaler®
indacaterol/glycopyrronium 110/50 Breezhaler® is a Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination) Small molecule drug developed by Wouter H. van Geffen. It is currently FDA-approved for Chronic obstructive pulmonary disease (COPD) maintenance therapy. Also known as: Ultibro.
Indacaterol is a long-acting beta-2 agonist and glycopyrronium is an anticholinergic that together relax airway smooth muscle and reduce mucus secretion to improve airflow in chronic obstructive pulmonary disease.
Indacaterol is a long-acting beta-2 agonist and glycopyrronium is an anticholinergic that together relax airway smooth muscle and reduce mucus secretion to improve airflow in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | indacaterol/glycopyrronium 110/50 Breezhaler® |
|---|---|
| Also known as | Ultibro |
| Sponsor | Wouter H. van Geffen |
| Drug class | Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination) |
| Target | Beta-2 adrenergic receptor; Muscarinic M3 acetylcholine receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Indacaterol activates beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and lasting up to 24 hours. Glycopyrronium blocks muscarinic acetylcholine receptors, providing additional bronchodilation and reducing mucus production. The combination provides dual bronchodilation through complementary mechanisms for sustained airway opening.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Cough
- Nasopharyngitis
Key clinical trials
- A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence (PHASE3)
- Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD (PHASE4)
- Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD. (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:
- indacaterol/glycopyrronium 110/50 Breezhaler® CI brief — competitive landscape report
- indacaterol/glycopyrronium 110/50 Breezhaler® updates RSS · CI watch RSS
- Wouter H. van Geffen portfolio CI
Frequently asked questions about indacaterol/glycopyrronium 110/50 Breezhaler®
What is indacaterol/glycopyrronium 110/50 Breezhaler®?
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Is indacaterol/glycopyrronium 110/50 Breezhaler® also known as anything else?
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Related
- Drug class: All Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination) drugs
- Target: All drugs targeting Beta-2 adrenergic receptor; Muscarinic M3 acetylcholine receptor
- Manufacturer: Wouter H. van Geffen — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Also known as: Ultibro
- Compare: indacaterol/glycopyrronium 110/50 Breezhaler® vs similar drugs
- Pricing: indacaterol/glycopyrronium 110/50 Breezhaler® cost, discount & access