NDAORALCAPSULE, DELAYED REL PELLETSPriority Review
Approved
Sep 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
PRILOSEC (omeprazole) by AstraZeneca is proton pump inhibitors [moa]. First approved in 1989.
Drug data last refreshed 8h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRILOSEC (omeprazole) is a proton pump inhibitor (PPI) that reduces gastric acid production by blocking H+/K+-ATPase in parietal cells. It is indicated for gastroesophageal reflux disease (GERD), peptic ulcer disease, and acid-related conditions. The drug is available as an oral delayed-release capsule and has been a cornerstone of acid-suppression therapy since FDA approval in 1989.
$3MPart D
LOE ApproachingDeclining
As LOE approaches, brand roles are contracting; focus shifts to generics optimization and specialty indications to extend franchise value.
Mechanism of Action
Proton Pump Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants
Started Jul 2026
30 enrolled
Healthy Participants
Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
Started Oct 2025
28 enrolled
Healthy Adult Participants
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
Started Sep 2025
22 enrolled
Healthy Volunteer
Effects of Omeprazole Ingestion on Postprandial Amino Acid Concentrations in Response to a Mixed Meal
Started Sep 2025
4 enrolled
Digestive HealthGastrointestinal Health
A Study of Food Effect and Esomeprazole on LY4064809 in Healthy Adult Participants
Started May 2025
36 enrolled
Healthy
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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.