NDAINHALATIONPOWDER, METERED
Approved
Jul 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PULMICORT FLEXHALER (budesonide) by Viatris (2) is corticosteroid hormone receptor agonists [moa]. First approved in 2006.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PULMICORT FLEXHALER is a metered-dose powder inhaler containing budesonide, a corticosteroid hormone receptor agonist approved by the FDA in July 2006. Despite its inhalation route, the labeled indication in this dataset is ulcerative colitis, suggesting potential off-label pulmonary use or a data classification issue. Budesonide works by binding corticosteroid receptors to reduce inflammation in affected tissues. The product is positioned as a cost-effective corticosteroid option in the treatment of inflammatory bowel disease.
$0.0BPart D
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
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.