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Budesonide / Formoterol
Budesonide reduces airway inflammation via glucocorticoid receptor activation, while formoterol dilates airways by activating beta-2 adrenergic receptors.
Budesonide reduces airway inflammation via glucocorticoid receptor activation, while formoterol dilates airways by activating beta-2 adrenergic receptors. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Budesonide / Formoterol |
|---|---|
| Also known as | Symbicort ®, Symbicort |
| Sponsor | Brigham and Women's Hospital |
| Drug class | Inhaled corticosteroid / long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Budesonide is an inhaled corticosteroid that suppresses inflammatory cytokines and immune cell recruitment in the lungs. Formoterol is a long-acting beta-2 agonist that increases intracellular cAMP, causing bronchial smooth muscle relaxation and sustained airway dilation. Together, they provide both anti-inflammatory and bronchodilatory effects for maintenance asthma and COPD therapy.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness
- Muscle cramps
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 / Formoterol CI brief — competitive landscape report
- Budesonide / Formoterol updates RSS · CI watch RSS
- Brigham and Women's Hospital portfolio CI