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Indacaterol Fumarate
Indacaterol fumarate is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle to cause bronchodilation and improve airflow.
Indacaterol fumarate is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle to cause bronchodilation and improve airflow. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Indacaterol Fumarate |
|---|---|
| Also known as | Onbrez Breezhaler (Novartis International AG, Basel Switzerland) |
| Sponsor | University of Milan |
| Drug class | Long-acting beta-2 agonist (LABA) |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
Mechanism of action
The drug activates beta-2 adrenergic receptors on bronchial smooth muscle cells, triggering a cascade that increases intracellular cAMP levels, leading to smooth muscle relaxation and sustained airway dilation. This long-acting formulation provides extended bronchodilation lasting 24 hours or more, making it suitable for once-daily maintenance therapy in chronic obstructive pulmonary disease.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Muscle cramps
- Nervousness
Key clinical trials
- ANTES B+ Clinical Trial (PHASE4)
- A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator (PHASE4)
- A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)
- Efficacy of Indacaterol 150 µg Versus Formoterol (PHASE4)
- A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils (PHASE2, PHASE3)
- Acute Effect of Pulmonary Desufflation on Cardiac Performance in COPD Patients (PHASE4)
- The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma (PHASE2)
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 Fumarate CI brief — competitive landscape report
- Indacaterol Fumarate updates RSS · CI watch RSS
- University of Milan portfolio CI