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 21h ago · AI intelligence enriched 1mo 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 diseases, particularly Crohn's disease and ulcerative colitis. The delayed-release formulation targets drug delivery to the distal ileum and colon, minimizing systemic absorption.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting transition planning and potential team restructuring within the commercial organization.
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 2029
100 enrolled
Ulcerative Colitis
QUARTZ: Comparative Effectiveness of Switching From Albuterol to Albuterol/Budesonide Versus Adding Low-dose ICS or LTRA to Albuterol
Started Aug 2026
8,681 enrolled
Asthma
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
16 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
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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.