NDAINHALATIONAEROSOL, METERED
Approved
Jul 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
BREZTRI AEROSPHERE (budesonide, glycopyrrolate, and formoterol fumarate) by AstraZeneca is corticosteroid hormone receptor agonists [moa]. Approved for corticosteroid [epc]. First approved in 2020.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BREZTRI AEROSPHERE is a triple-combination inhaled corticosteroid/long-acting muscarinic antagonist/long-acting beta-2 agonist (ICS/LAMA/LABA) containing budesonide, glycopyrrolate, and formoterol fumarate. It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in patients not adequately controlled on dual-therapy combinations. The product works through three complementary mechanisms: budesonide reduces airway inflammation via corticosteroid receptor agonism, glycopyrrolate provides bronchodilation through muscarinic antagonism, and formoterol provides additional rapid and sustained bronchodilation via beta-2 agonism. As a metered-dose aerosol, BREZTRI represents a convenient once- or twice-daily maintenance option in the crowded COPD market.
$0.8BPart D
12.4 years to LOEMechanism 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 (1)
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
Started Dec 2025
150 enrolled
Moderate to Severe COPD
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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.