PANTOPRAZOLE SODIUM
Pantoprazole sodium is an injectable proton pump inhibitor indicated for the short-term treatment (up to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis. It is also indicated for the management of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. It is intended for use when oral therapy is not appropriate.
How PANTOPRAZOLE SODIUM Works
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step of gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of gastric parietal cells. This action inhibits both basal and stimulated gastric acid secretion, regardless of the stimulus. Because of the irreversible nature of this covalent binding, the antisecretory effect persists for more than 24 hours.
Details
- Status
- Discontinued
- First Approved
- 2007-08-02
- Routes
- ORAL, INTRAVENOUS, INJECTION
- Dosage Forms
- TABLET, DELAYED RELEASE, INJECTABLE, POWDER, FOR SUSPENSION, DELAYED RELEASE
Companies
PANTOPRAZOLE SODIUM Approval History
What PANTOPRAZOLE SODIUM Treats
4 indicationsPANTOPRAZOLE SODIUM is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis (EE)
- Pathological hypersecretory conditions
- Zollinger-Ellison (ZE) Syndrome
PANTOPRAZOLE 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.
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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3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
PANTOPRAZOLE SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)PANTOPRAZOLE SODIUM is indicated for the treatment of Gastroesophageal reflux disease (GERD); Erosive esophagitis (EE); Pathological hypersecretory conditions; Zollinger-Ellison (ZE) Syndrome.
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PROTONIX
Full clinical data, patents, trials, and competitive landscape for pantoprazole sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.