NDAORALTABLET, DELAYED RELEASE
Approved
Jun 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
3/8 — Basic
PRILOSEC OTC (omeprazole magnesium) by AstraZeneca is compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the h/k atpase enzyme system at the secretory surface of the gastric parietal cell. First approved in 2003.
Drug data last refreshed 2d ago
Mechanism of Action
compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H/K ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
Started Oct 2024
40 enrolled
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
Started Aug 2024
30 enrolled
Healthy Subjects
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
Started Sep 2008
24 enrolled
Healthy Volunteers
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Started May 2008
60 enrolled
Gastric AcidHuman Experimentation
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Started Apr 2008
60 enrolled
Gastric AcidHuman Experimentation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.