ESOMEPRAZOLE SODIUM
Esomeprazole sodium is an injectable medication used to manage gastroesophageal reflux disease (GERD) and erosive esophagitis in adults and children as young as one month old. It serves as a short-term alternative for patients who are unable to take oral versions of the medication. This drug also helps adults by reducing the risk of gastric or duodenal ulcers rebleeding after they have undergone a procedure to treat an acute bleed.
How ESOMEPRAZOLE SODIUM Works
This drug works by targeting the H+/K+ ATPase enzyme system, often called the proton pump, located on the surface of gastric parietal cells. Once it enters the acidic environment of these cells, it converts into an active form that blocks the final step of acid production. This process effectively reduces the amount of acid the stomach secretes, regardless of the original stimulus.
Details
- Status
- Discontinued
- First Approved
- 2013-03-18
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
Companies
ESOMEPRAZOLE SODIUM Approval History
What ESOMEPRAZOLE SODIUM Treats
4 indicationsESOMEPRAZOLE SODIUM is approved for 4 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Gastric Ulcer
- Duodenal Ulcer
ESOMEPRAZOLE SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ESOMEPRAZOLE SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)ESOMEPRAZOLE SODIUM is indicated for the treatment of Gastroesophageal Reflux Disease; Erosive Esophagitis; Gastric Ulcer; Duodenal Ulcer.
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Full clinical data, patents, trials, and competitive landscape for esomeprazole sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.