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Prilosec OTC®
Prilosec OTC inhibits the proton pump in gastric parietal cells, reducing stomach acid production.
Prilosec OTC inhibits the proton pump in gastric parietal cells, reducing stomach acid production. Used for Frequent heartburn (≥2 days per week), Over-the-counter acid reflux symptom relief.
At a glance
| Generic name | Prilosec OTC® |
|---|---|
| Sponsor | Procter and Gamble |
| Drug class | Proton pump inhibitor (PPI) |
| Target | H+/K+-ATPase (proton pump) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Omeprazole, the active ingredient, irreversibly binds to and inhibits the H+/K+-ATPase enzyme (proton pump) on the secretory surface of gastric parietal cells. This blocks the final step of gastric acid secretion, significantly reducing intragastric acidity. The effect is sustained and dose-dependent, providing relief from acid-related symptoms over several days of treatment.
Approved indications
- Frequent heartburn (≥2 days per week)
- Over-the-counter acid reflux symptom relief
Common side effects
- Headache
- Diarrhea
- Abdominal pain
- Nausea
Key clinical trials
- Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir (PHASE1)
- A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005) (PHASE1)
- Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers (PHASE1)
- Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression (PHASE4)
- A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED) (PHASE3)
- A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) (PHASE3)
- A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12) (PHASE1)
- A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540 (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prilosec OTC® CI brief — competitive landscape report
- Prilosec OTC® updates RSS · CI watch RSS
- Procter and Gamble portfolio CI