PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE (pantoprazole sodium)
Pantoprazole sodium helps adults manage gastroesophageal reflux disease (GERD) and is used for those with a history of erosive esophagitis. This medication is intended for short-term use, typically for up to 10 days. It also treats pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, where the stomach produces excessive amounts of acid.
How PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE Works
This medication works by binding to the (H+, K+)-ATPase enzyme system on the surface of gastric parietal cells to block the final step of acid production. By inhibiting this enzyme, the drug suppresses both basal and stimulated gastric acid secretion regardless of the trigger. This binding creates a long-lasting effect that reduces stomach acid for more than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2024-02-14
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE Approval History
What PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE Treats
4 indicationsPANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathological Hypersecretory Conditions
- Zollinger-Ellison Syndrome
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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
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Key Completed Trials
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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.
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Gastroesophageal Reflux Disease; Erosive Esophagitis; Pathological Hypersecretory Conditions; Zollinger-Ellison Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.