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budesonide and formoterol
Budesonide reduces inflammation, while formoterol relaxes airway muscles, together improving symptoms of COPD and asthma.
At a glance
| Generic name | budesonide and formoterol |
|---|---|
| Also known as | Symbicort |
| Sponsor | National Jewish Health |
| Drug class | Corticosteroid [EPC] |
| Target | Glucocorticoid receptor, beta 2 -adrenoceptor |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Budesonide, a corticosteroid, reduces inflammation in the lungs by inhibiting various immune cells and mediators involved in allergic and non-allergic inflammation. Formoterol, a long-acting beta 2 -adrenergic agonist, relaxes bronchial smooth muscle and inhibits the release of inflammatory mediators, providing bronchodilation.
Approved indications
- Treatment of Asthma
- Maintenance Treatment of COPD
Common side effects
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Pharyngolaryngeal pain
- Sinusitis
- Influenza
- Back pain
- Nasal congestion
- Stomach discomfort
- Vomiting
- Oral Candidiasis
Drug interactions
- Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir)
- Monoamine oxidase inhibitors and tricyclic antidepressants
- Beta-blockers
- Diuretics
Key clinical trials
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- 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)
- Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo
- Ventilation and Perfusion in Asthmatics (PHASE4)
- A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma (PHASE1)
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:
- budesonide and formoterol CI brief — competitive landscape report
- budesonide and formoterol updates RSS · CI watch RSS
- National Jewish Health portfolio CI