Overview
Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .
Indication
Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes: • 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 • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. • 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 adults
Associated Conditions
- Ankylosing Spondylitis (AS)
- Duodenal Ulcer
- Erosive Esophagitis
- Gastric Ulcer
- Gastro-esophageal Reflux Disease (GERD)
- Healing
- Heartburn
- Helicobacter Pylori Infection
- Osteoarthritis (OA)
- Rheumatoid Arthritis
- Upper GI Bleeding
- Zollinger-Ellison Syndrome
- Benign, active Gastric Ulcer
- Develop NSAID-induced gastric ulcers
- Hypersecretory conditions
- Multiple endocrine adenomas
Research Report
A Comprehensive Monograph on Omeprazole (DB00338): From Molecular Mechanism to Clinical Practice
Introduction and Drug Identification
Overview and Significance
Omeprazole is a seminal small molecule drug that represents a cornerstone in the management of acid-related gastrointestinal disorders.[1] As the first clinically successful proton pump inhibitor (PPI), its introduction marked a paradigm shift in gastroenterology, offering a level of gastric acid suppression that was significantly more potent and sustained than previously available agents like histamine-2 receptor antagonists (
H2RAs).[2] Classified chemically as a substituted benzimidazole, omeprazole has demonstrated profound efficacy in treating conditions ranging from gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD) to rare hypersecretory states.[1] Its global importance is underscored by its inclusion on the World Health Organization's List of Essential Medicines and its immense prescription volume; in 2022, it was the ninth most commonly prescribed medication in the United States, accounting for over 52 million prescriptions.[6]
Historical Context and Regulatory Milestones
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/08/19 | Phase 1 | Completed | |||
2013/08/14 | Phase 1 | Completed | |||
2013/07/30 | Phase 1 | Completed | |||
2013/07/17 | Phase 4 | Completed | Daniel Freedberg, MD | ||
2013/07/11 | Phase 4 | Completed | |||
2013/05/13 | Phase 4 | Completed | |||
2013/04/04 | Early Phase 1 | Withdrawn | |||
2013/04/04 | Phase 1 | Completed | |||
2013/04/02 | Phase 4 | Completed | |||
2013/03/19 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Unit Dose Services | 50436-0065 | ORAL | 20 mg in 1 1 | 2/28/2017 | |
| Zydus Lifesciences Limited | 65841-759 | ORAL | 10 mg in 1 1 | 9/27/2023 | |
| Covis Pharma US, Inc | 70515-625 | ORAL | 2.5 mg in 1 1 | 12/17/2021 | |
| Lannett Company, Inc. | 62175-136 | ORAL | 40 mg in 1 1 | 4/21/2023 | |
| NorthStar Rx LLC | 16714-634 | ORAL | 20 mg in 1 1 | 6/15/2023 | |
| Northwind Pharmaceuticals | 51655-061 | ORAL | 20 mg in 1 1 | 12/31/2021 | |
| Golden State Medical Supply, Inc. | 51407-129 | ORAL | 20 mg in 1 1 | 10/16/2023 | |
| Golden State Medical Supply, Inc. | 51407-256 | ORAL | 20 mg in 1 1 | 10/16/2023 | |
| Dr.Reddy's Laboratories Limited | 55111-364 | ORAL | 40 mg in 1 1 | 3/20/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4024 | ORAL | 20 mg in 1 1 | 2/12/2021 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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