PRILOSEC (omeprazole magnesium) · AZURITY
Prilosec is a proton pump inhibitor (PPI) indicated for the short-term treatment of active duodenal ulcer and active benign gastric ulcer in adults. It is used to manage symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older, and to treat and maintain healing of erosive esophagitis (EE) in pediatric patients as young as 1 month and 1 year, respectively. Additionally, it is indicated in combination with antibiotics for the eradication of *H. pylori* to reduce the risk of duodenal ulcer recurrence, and for the long-term treatment of pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome) in adults.
How PRILOSEC Works
Omeprazole belongs to the substituted benzimidazole class of antisecretory compounds. It suppresses gastric acid secretion by specifically inhibiting the $H^+/K^+$ ATPase enzyme system—often referred to as the "proton pump"—at the secretory surface of the gastric parietal cell. By inhibiting this enzyme, omeprazole blocks the final step of acid production. This effect is dose-related and inhibits both basal and stimulated acid secretion, regardless of the stimulus.
Details
- Status
- Prescription
- First Approved
- 1989-09-14
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, DELAYED RELEASE, CAPSULE, DELAYED REL PELLETS
PRILOSEC Approval History
What PRILOSEC Treats
6 indicationsPRILOSEC is approved for 6 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duodenal Ulcer
- Helicobacter pylori Infection
- Gastric Ulcer
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathologic Hypersecretory Conditions
PRILOSEC 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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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02504554 BBT results posted | STUDY00001053 | Ph 1, Ph 2 | completed | Beneficial Bacteria Treatment for Autism |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT00674115 results posted | 18133 CL2007-17, P07813 | Ph 3 | completed | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) |
| NCT01337804 | 18136 P08050 | Ph 1 | completed | A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12) |
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.
PRILOSEC FDA Label Details
Indications & Usage
FDA Label (PDF)PRILOSEC is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adul...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.