NDAINHALATIONPOWDER, METERED
Approved
Jun 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PULMICORT (budesonide) by AstraZeneca is corticosteroid hormone receptor agonists [moa]. First approved in 1997.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PULMICORT (budesonide) is an inhaled corticosteroid that acts as a glucocorticoid receptor agonist to reduce airway inflammation and bronchospasm. It treats asthma, COPD, allergic rhinitis, eosinophilic esophagitis, and inflammatory bowel conditions including ulcerative colitis and proctitis. The drug delivers localized anti-inflammatory action directly to affected tissues via metered powder inhalation.
$0.222BPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Part D penetration; brand teams should prepare transition strategies and cost-containment initiatives.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
Started Jun 2027
100 enrolled
Ulcerative Colitis
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
Started Mar 2026
12 enrolled
Asthma
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
Started Nov 2025
56 enrolled
Chronic Obstructive Pulmonary DiseaseHyperinflation
Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
Started Apr 2025
2,000 enrolled
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
Started Jan 2025
105 enrolled
Healthy Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.