NDAORALCAPSULE, DELAYED REL PELLETSPriority Review
Approved
Feb 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
NEXIUM (esomeprazole magnesium) by AstraZeneca is compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the h+/k+ atpase enzyme system at the secretory surface of the gastric parietal cell. First approved in 2001.
Drug data last refreshed 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEXIUM (esomeprazole magnesium) is an oral proton pump inhibitor approved in 2001 for the treatment of frequent heartburn occurring 2 or more days per week. It works by specifically inhibiting the H+/K+ ATPase enzyme system in gastric parietal cells, blocking the final step of gastric acid production. The drug is supplied as delayed-release capsules and is not intended for immediate heartburn relief, requiring 1-4 days for full therapeutic effect. It represents a standard-of-care agent in the acid suppression therapy category.
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Mechanism of Action
compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Esomeprazole is protonated and converted in the acidic compartment of the parietal cell forming the active…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
Started Oct 2024
40 enrolled
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
Started Aug 2024
30 enrolled
Healthy Subjects
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
Started Jul 2022
53 enrolled
Erosive Esophagitis
S-CEI of Nexium in Paediatric Patients
Started Jun 2018
240 enrolled
Peptic Ulcer, Gastroesophageal Reflux
Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
Started Jul 2015
1,595 enrolled
Reflux Esophagitis
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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.