NDAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Oct 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ENTOCORT EC (budesonide) by Design Pharmaceuticals is corticosteroid hormone receptor agonists [moa]. First approved in 2001.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENTOCORT EC is an oral delayed-release capsule formulation of budesonide, a corticosteroid that acts as a hormone receptor agonist to reduce inflammation. It is indicated for inflammatory bowel conditions where it targets mucosal inflammation through local corticosteroid activity. The delayed-release formulation delivers budesonide to the ileum and colon, minimizing systemic absorption and side effects.
LOE Approaching
As LOE approaches, commercial teams should anticipate revenue consolidation and resource reallocation to higher-growth assets within the pipeline.
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.