NDAINHALATIONSUSPENSIONPriority Review
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
PULMICORT RESPULES (budesonide) by AstraZeneca is corticosteroid hormone receptor agonists [moa]. First approved in 2000.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PULMICORT RESPULES is a corticosteroid suspension delivered via inhalation for respiratory inflammatory conditions. It contains budesonide, which acts as a corticosteroid hormone receptor agonist to reduce airway inflammation and improve breathing. The product is indicated for patients requiring inhaled corticosteroid therapy for asthma and other obstructive airway diseases.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30), signaling transition planning and potential team restructuring ahead.
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
15 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.