NDAORALTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Approved
Oct 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
4/8 — Partial
ESOMEPRAZOLE MAGNESIUM (esomeprazole magnesium) by Bridge Therapeutics 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 2020.
Drug data last refreshed 1m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Esomeprazole magnesium is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system in gastric parietal cells. It is formulated as an orally disintegrating delayed-release tablet for patients requiring acid suppression. The drug blocks the final step of acid production, providing dose-related inhibition of both basal and stimulated gastric acid secretion.
Peak10.5 years to LOE
Product is at peak commercial stage with established market presence; commercial teams are focused on market maintenance and optimization rather than aggressive growth.
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 (6)
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
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
Started Aug 2006
40 enrolled
Endoscopically-Proven GERDReflux
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
Started Apr 2006
961 enrolled
AsthmaGERD
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
Started Dec 2002
1,000 enrolled
Erosive 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.