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Prilosec (omeprazole)
Prilosec (generic name: omeprazole) is a Proton pump inhibitor (PPI) Small molecule drug developed by AstraZeneca (originally Astra AB). It is currently FDA-approved (first approved 1989) for Duodenal Ulcer due to H. Pylori, Duodenal ulcer disease, Erosive esophagitis. Also known as: Prilosec, Losec, Omez.
Irreversibly inhibits the hydrogen-potassium ATPase (proton pump) in gastric parietal cells, potently suppressing stomach acid secretion.
Prilosec, also known as omeprazole, is a small molecule inhibitor of the potassium-transporting ATPase. It is used to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger–Ellison syndrome.
At a glance
| Generic name | omeprazole |
|---|---|
| Also known as | Prilosec, Losec, Omez |
| Sponsor | AstraZeneca (originally Astra AB) |
| Drug class | Proton pump inhibitor (PPI) |
| Target | ATP-binding cassette sub-family G member 2, Cytochrome P450 1A2, Cytochrome P450 2C19 |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
| First approval | 1989-09-14 (United States) |
| Annual revenue | 1041 |
Mechanism of action
Omeprazole was the first proton pump inhibitor, revolutionizing the treatment of acid-related disorders. It works by irreversibly binding to the hydrogen-potassium ATPase enzyme system on the surface of gastric parietal cells, blocking the final step of acid production. A single dose suppresses about 90% of daily gastric acid output. Developed by Astra AB, it became one of the best-selling drugs in pharmaceutical history and is now available OTC.
Approved indications
- Duodenal Ulcer due to H. Pylori
- Duodenal ulcer disease
- Erosive esophagitis
- Gastric Hypersecretory Conditions
- Gastric ulcer
- Gastroesophageal reflux disease
- Maintenance of Healing Erosive Esophagitis
- Pathological Gastric Hypersecretory Condition
- Peptic reflux disease
- Peptic ulcer
- Reduction of risk of upper gastrointestinal bleeding
- Zollinger-Ellison syndrome
Common side effects
Key clinical trials
- An Open-Label, Parallel-Group, Multi-Centre Study to Determine the Effect of Treatment With Esomeprazole for Six Months on Histological Markers of Esophageal Epithelial Acid-Related Disease in Patient (Phase 3)
- Clinical Study on Bifidobacterium Quadruple Live Bacteria Tablets (Si Lian Kang) Reducing the Incidence Rate of Adverse Reactions in Helicobacter Pylori Quadruple Eradication Therapy and on the Effect (Phase 4)
- A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia. (Phase 2)
- A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in Patients With Castration-resis (Phase 1)
- Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endos (Phase 3)
- Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; a Double-Blind Placebo-Controlled Randomised Study. (Phase 4)
- A Phase 1, Open-label, Single-sequence, Non-randomized, Crossover, Drug-Drug Interaction Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Heal (Phase 1)
- Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants (Phase 4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10835488 | 2036-12-08 | Formulation |
| 10076494 | 2036-12-08 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prilosec CI brief — competitive landscape report
- Prilosec updates RSS · CI watch RSS
- AstraZeneca (originally Astra AB) portfolio CI
Frequently asked questions about Prilosec
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Related
- Drug class: All Proton pump inhibitor (PPI) drugs
- Target: All drugs targeting ATP-binding cassette sub-family G member 2, Cytochrome P450 1A2, Cytochrome P450 2C19
- Manufacturer: AstraZeneca (originally Astra AB) — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Duodenal Ulcer due to H. Pylori
- Indication: Drugs for Duodenal ulcer disease
- Indication: Drugs for Erosive esophagitis
- Also known as: Prilosec, Losec, Omez
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing