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Budesonide HFA
Budesonide is a corticosteroid that reduces inflammation in the airways by binding to glucocorticoid receptors and suppressing inflammatory mediator production.
Budesonide is a corticosteroid that reduces inflammation in the airways by binding to glucocorticoid receptors and suppressing inflammatory mediator production. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Budesonide HFA |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Inhaled corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Budesonide acts as a selective glucocorticoid receptor agonist that decreases airway inflammation, mucus production, and bronchial hyperresponsiveness. The HFA (hydrofluoroalkane) formulation is a pressurized metered-dose inhaler that delivers the drug directly to the lungs for local anti-inflammatory effects with minimal systemic absorption.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Nervousness
- Palpitations
- Muscle cramps
- Throat irritation
Key clinical trials
- Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (PHASE3)
- Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma (PHASE4)
- A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma (PHASE3)
- A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PHASE3)
- Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant (PHASE1)
- A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD (PHASE3)
- A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant (PHASE1)
- A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer (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 HFA CI brief — competitive landscape report
- Budesonide HFA updates RSS · CI watch RSS
- AstraZeneca portfolio CI