Last reviewed · How we verify
Budesonide/Glycopyrronium/Formoterol Fumarate
This triple-combination inhaler delivers a corticosteroid (budesonide) to reduce airway inflammation, a long-acting beta-2 agonist (formoterol) to dilate airways, and an anticholinergic (glycopyrronium) to further relax airway smooth muscle.
This triple-combination inhaler delivers a corticosteroid (budesonide) to reduce airway inflammation, a long-acting beta-2 agonist (formoterol) to dilate airways, and an anticholinergic (glycopyrronium) to further relax airway smooth muscle. Used for Chronic obstructive pulmonary disease (COPD) maintenance treatment, Asthma maintenance treatment (in some markets).
At a glance
| Generic name | Budesonide/Glycopyrronium/Formoterol Fumarate |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) |
| Target | Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol); muscarinic M3 receptor (glycopyrronium) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Budesonide suppresses inflammatory responses in the airways by binding glucocorticoid receptors. Formoterol activates beta-2 adrenergic receptors to increase cAMP and cause bronchodilation. Glycopyrronium blocks muscarinic acetylcholine receptors to prevent bronchoconstriction. Together, these three agents provide anti-inflammatory and dual bronchodilatory effects for sustained airway opening and reduced exacerbations.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
- Asthma maintenance treatment (in some markets)
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Nasopharyngitis
- Oral candidiasis
Key clinical trials
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care 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)
- Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation
- Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (PHASE4)
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: