Data updated: Jun 28, 2026
PRILOSEC (omeprazole) · AstraZeneca
Gastrointestinal
Approved 1989-09-14
Prilosec is a proton pump inhibitor (PPI) indicated for the short-term treatment of active duodenal ulcer and active benign gastric ulcer in adults. It is used to manage symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older, and to treat and maintain healing of erosive esophagitis (EE) in pediatric patients as young as 1 month and 1 year, respectively. Additionally, it is indicated in combination with antibiotics for the eradication of *H. pylori* to reduce the risk of duodenal ulcer recurrence, and for the long-term treatment of pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome) in adults.
How PRILOSEC Works
Omeprazole belongs to the substituted benzimidazole class of antisecretory compounds. It suppresses gastric acid secretion by specifically inhibiting the $H^+/K^+$ ATPase enzyme system—often referred to as the "proton pump"—at the secretory surface of the gastric parietal cell. By inhibiting this enzyme, omeprazole blocks the final step of acid production. This effect is dose-related and inhibits both basal and stimulated acid secretion, regardless of the stimulus.
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Indications
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Phase 3 Trials
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Priority Reviews
36
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1989-09-14
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, FOR SUSPENSION, DELAYED RELEASE
PRILOSEC Approval History
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314 FDA actions from 1989 to 2023 · 9 indication expansions
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Sep 1989 ORIGINAL Priority
New Drug
What PRILOSEC Treats
6 indicationsPRILOSEC is approved for 6 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duodenal Ulcer
- Helicobacter pylori Infection
- Gastric Ulcer
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathologic Hypersecretory Conditions
Source: FDA Label
PRILOSEC Competitive Set
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Direct competitors
10
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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Clinical Trial Registry
157 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy |
| NCT07214662 | GO46057 | Ph 1 | recruiting | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer |
| NCT06686628 | INT18404 U1111-1303-3406, 2024-513495-17 | Ph 1 | completed | An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates |
| NCT02783040 results posted | 1346.22 2015-001371-41 | Ph 1 | completed | Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin |
| NCT07223671 | CA127-1088 | Ph 1 | completed | Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants |
| NCT06562907 | GS-US-506-6610 | Ph 1 | recruiting | Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT07235748 | S095032-230 | Ph 1 | completed | Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants |
| NCT05444556 results posted | 18413 J2J-MC-JZLI | Ph 1 | completed | A Study of Imlunestrant (LY3484356) in Female Healthy Participants |
| NCT04840888 results posted | 18204 J2J-MC-JZLD | Ph 1 | completed | A Study of LY3484356 in Healthy Female Participants |
| NCT02950259 results posted | 16-126B IRX-2 2016-B | Ph 1 | completed | Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) |
| NCT06494761 results posted | 1479-0014 2023-510263-35-00, U1111-1301-9035 | Ph 1 | completed | A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body |
| NCT07156201 | ABS1230-1001 | Ph 1 | recruiting | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Given Orally Compared With Placebo in Healthy Participants Aged 18 to 55 Years |
| NCT07149415 | 296HV104 | Ph 1 | completed | 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 |
| NCT05468164 results posted | 17752 J2G-MC-JZJQ, LOXO-RET-18015 | Ph 1 | completed | A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants |
| NCT02504554 BBT results posted | STUDY00001053 | Ph 1, Ph 2 | completed | Beneficial Bacteria Treatment for Autism |
| NCT05680870 | MS.22.12.2244.R1 | Ph 3 | completed | The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients |
| NCT06383338 PEGASUS | PEGASUS 2023/ETH01954 | Ph 1 | recruiting | A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma. |
| NCT06948006 | D9441C00003 | Ph 1 | completed | A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants |
| NCT06605950 | CN012-0030 | Ph 1 | completed | A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants |
| NCT05487235 | GO43712 2021-006479-40 | Ph 1 | completed | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors |
| NCT07037888 Keto | 16671 | Ph 4 | recruiting | Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective Double-Blinded Randomized Controlled Trial |
| NCT06279234 | C4001002 NCT06279234 | Ph 1 | completed | A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus |
| NCT03267680 results posted | 5GYN-16-2 NCI-2017-01402, 5GYN-16-2 | Ph 2 | terminated | IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 |
| NCT06162169 | JAB-21822-1010 | Ph 1 | completed | A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects |
| NCT05581992 | 20190320 | Ph 1 | completed | Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants |
| NCT03556592 | LP0162-1342 2018-000534-35 | Ph 1 | completed | Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 |
| NCT06322706 | ABSK021-105 | Ph 1 | completed | A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021 |
| NCT06822166 | ET-26-HCL-CP-006 | Ph 1 | completed | Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride |
| NCT02638116 | CR108106 2015-005015-32, PCI-32765CLL1005 | Ph 1 | completed | A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults |
| NCT01499368 results posted | LAF-BR-CT-302 | Ph 3 | completed | A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients |
| NCT05134350 results posted | LOXO-BTK-20014 J2N-OX-JZNH | Ph 1 | completed | Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants |
| NCT05599828 | 20200199 | Ph 1 | completed | A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants |
| NCT05981365 results posted | GBT440-0122 C5341029 | Ph 1 | completed | Voxelotor CYP and Transporter Cocktail Interaction Study |
| NCT05338502 results posted | 17574 J2G-OX-JZJL, LOXO-RET-19075 | Ph 1 | completed | Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants |
| NCT03864042 results posted | ARRAY-818-103 C4221003, 2019-001036-66 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors |
| NCT04246762 results posted | CL04041026 | Ph 1 | completed | Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4 |
| NCT05067439 results posted | B7451092 | Ph 1 | completed | A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants |
| NCT06031454 | RAY1216-23-05 | Ph 1 | completed | Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin |
| NCT05635110 | VX22-548-013 | Ph 1 | completed | Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants |
| NCT02609386 INSPIRE results posted | IRX-2 2015-A | Ph 2 | completed | IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity |
| NCT05497557 results posted | 20220024 | Ph 1 | completed | A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers |
| NCT04028466 | RP 19-007 | Ph 4 | terminated | Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features |
| NCT05932277 | CN007-1000 | Ph 1 | completed | A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants |
| NCT05852769 | IM038-022 | Ph 1 | completed | A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants |
| NCT05319912 results posted | WTX101-102 CA13895 | Ph 1 | completed | A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults |
| NCT05319899 results posted | WTX101-101 CA12887 | Ph 1 | completed | A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults |
| NCT03531762 results posted | MS200095_0039 2017-002832-18 | Ph 1 | completed | Effect of a Proton Pump Inhibitor on the PK of Tepotinib |
| NCT03028103 results posted | EZH-105 | Ph 1 | completed | Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT02740712 DDI | CO-338-044 | Ph 1 | completed | Pharmacokinetic Drug-Drug Interaction Study of Rucaparib |
Showing 50 of 157 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRILOSEC FDA Label Details
Indications & Usage
FDA Label (PDF)PRILOSEC is a proton pump inhibitor (PPI) indicated for the: • 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 • 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 adul...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.