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Indacaterol/glycopyrronium
Indacaterol is a long-acting beta-2 agonist that stimulates airway smooth muscle relaxation, while glycopyrronium is an anticholinergic that blocks muscarinic receptors to further dilate airways.
Indacaterol is a long-acting beta-2 agonist that stimulates airway smooth muscle relaxation, while glycopyrronium is an anticholinergic that blocks muscarinic receptors to further dilate airways. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Indacaterol/glycopyrronium |
|---|---|
| Also known as | Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C with charcoal, Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule with charcoal |
| Sponsor | Orion Corporation, Orion Pharma |
| Drug class | Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination) |
| Target | Beta-2 adrenergic receptor; M3 muscarinic acetylcholine receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Indacaterol activates beta-2 adrenergic receptors on bronchial smooth muscle, causing bronchodilation and improved airflow. Glycopyrronium blocks M3 muscarinic receptors, preventing acetylcholine-induced bronchoconstriction. Together, these complementary mechanisms provide dual bronchodilation for sustained airway opening in chronic obstructive pulmonary disease.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Urinary retention
- Tachycardia
Key clinical trials
- 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)
- A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (PHASE2)
- Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD (NA)
- A 24-week rPMS Study in Real-world Setting for Enerzair
- A Trial to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD (PHASE2)
- A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD (PHASE3)
- Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
- Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
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 CI brief — competitive landscape report
- Indacaterol/glycopyrronium updates RSS · CI watch RSS
- Orion Corporation, Orion Pharma portfolio CI