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Glycopyrronium/Formoterol Fumarate
Glycopyrronium/Formoterol Fumarate is a LAMA/LABA combination (Long-Acting Muscarinic Antagonist / Long-Acting Beta-2 Agonist) Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
Glycopyrronium is an anticholinergic agent that blocks muscarinic receptors to reduce airway secretions and improve bronchial tone, while formoterol is a long-acting beta-2 agonist that relaxes airway smooth muscle to improve airflow.
Glycopyrronium is an anticholinergic agent that blocks muscarinic receptors to reduce airway secretions and improve bronchial tone, while formoterol is a long-acting beta-2 agonist that relaxes airway smooth muscle to improve airflow. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Glycopyrronium/Formoterol Fumarate |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | LAMA/LABA combination (Long-Acting Muscarinic Antagonist / Long-Acting Beta-2 Agonist) |
| Target | Muscarinic M3 receptor; Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
This combination inhaler delivers two complementary bronchodilators: glycopyrronium (a long-acting muscarinic antagonist or LAMA) blocks parasympathetic signaling to reduce bronchoconstriction and mucus production, while formoterol (a long-acting beta-2 agonist or LABA) activates beta-2 adrenergic receptors on airway smooth muscle to promote relaxation and bronchodilation. Together, they provide dual-mechanism airway opening for sustained symptom relief.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Tachycardia
- Muscle cramps
Key clinical trials
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
- A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation (PHASE4)
- Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
- A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (PHASE3)
- A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (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:
- Glycopyrronium/Formoterol Fumarate CI brief — competitive landscape report
- Glycopyrronium/Formoterol Fumarate updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Glycopyrronium/Formoterol Fumarate
What is Glycopyrronium/Formoterol Fumarate?
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Who makes Glycopyrronium/Formoterol Fumarate?
What drug class is Glycopyrronium/Formoterol Fumarate in?
What development phase is Glycopyrronium/Formoterol Fumarate in?
What are the side effects of Glycopyrronium/Formoterol Fumarate?
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Related
- Drug class: All LAMA/LABA combination (Long-Acting Muscarinic Antagonist / Long-Acting Beta-2 Agonist) drugs
- Target: All drugs targeting Muscarinic M3 receptor; Beta-2 adrenergic receptor
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Compare: Glycopyrronium/Formoterol Fumarate vs similar drugs
- Pricing: Glycopyrronium/Formoterol Fumarate cost, discount & access