Omeprazole clinical trials
Omeprazole is named as an intervention in 16 current clinical trials in our USA, Belgium, Poland, China, Australia, UK, Germany, Spain, Canada, Mexico, Singapore, France, Italy, Turkey, Brazil, South Korea, Taiwan and Denmark registers. 11 are recruiting patients now. The most common phase is Phase 1. The sponsor with the most trials is Hoffmann-La Roche (2). The most-studied condition is Active Ulcerative Colitis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Omeprazole is approved
All regulators →Of the three regulators tracked here, the first to approve Omeprazole was the US, on 14 Sep 1989. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Omeprazole patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Omeprazole, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 8 Dec 2036 (US 10835488).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Omeprazole
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Omeprazole works
All drug targets →- Potassium-transporting ATPase inhibitor InhibitorTarget: Potassium-transporting ATPase✓ In ChEMBL and the Guide to Pharmacology
- Arterial thrombosisPhase 3
- Helicobacter pylori infectious diseasePhase 3
- Parkinson diseasePhase 3
- Colorectal cancerPhase 3
- Malignant pancreatic neoplasmPhase 3
- NeuropathyPhase 3
- Pancreatic neoplasmPhase 3
- Peptic esophagitisPhase 3
- Type 1 diabetes mellitusPhase 3
- Crohn diseasePhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1503, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4279, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Omeprazole
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Omeprazole.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| The clinical and cost effectiveness of proton pump inhibitors for the treatment of dyspepsia NICE TA7 | Recommended | 23 Jul 2000 | Replaced |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Omeprazole
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 29 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Omeprazole
- ATC code
- A02BC01
- ChEMBL
- CHEMBL1503
- DrugBank
- DB00338
- PubChem CID
- 4594
- CAS number
- 73590-58-6
- FDA UNII
- KG60484QX9
- Wikidata
- Q422210
- Wikipedia
- Omeprazole
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Omeprazole
16 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Omeprazole in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Omeprazole. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial
2026-527509-39-01 · CTIS ↗ · Neoplasms
|
Phase 1 | Authorised | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Netherlands |
Omeprazole across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
29 single-substance products containing Omeprazole on the HPRA medicines list.
- Losec Control 20 mg gastro-resistant tabletsBayer Limited · PA1410/066/001 · Marketed
- Losec MUPS 10 mg gastro-resistant tabletsCHEPLAPHARM Arzneimittel GmbH · PA2239/009/001 · Marketed
- Losec MUPS 10 mg gastro-resistant tabletsPCO Manufacturing Ltd. · PPA0465/423/003 · Marketed
- Losec MUPS 20 mg gastro-resistant tabletsCHEPLAPHARM Arzneimittel GmbH · PA2239/009/002 · Marketed
- Losec MUPS 40 mg gastro-resistant tabletsCHEPLAPHARM Arzneimittel GmbH · PA2239/009/003 · Marketed
Supply shortages
No entry for Omeprazole in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Omeprazole
23 conditionsAll 23 conditions
| Condition (as registered) | Trials |
|---|---|
| Active Ulcerative Colitis | 1 |
| Breast Cancer | 1 |
| Healthy | 1 |
| Weight Management | 1 |
| Healthy Subjects | 1 |
| Chemotherapy Effect | 1 |
| Helicobacter Pylori Infection | 1 |
| Dyspepsia | 1 |
| Gastrointestinal Adverse Effects | 1 |
| Early-stage Breast Cancer | 1 |
| Estrogen-receptor-positive Breast Cancer | 1 |
| Gastroesophageal Reflux | 1 |
| Infant, Newborn, Diseases | 1 |
| Crohn Disease (CD) | 1 |
| Venous Thromboembolism | 1 |
| Gastro Intestinal Bleeding | 1 |
| Blood Clot | 1 |
| Morbidity | 1 |
| Metabolite | 1 |
| Idiopathic Granulomatous Mastitis | 1 |
| Hodgkin Lymphoma | 1 |
| Non Hodgkin Lymphoma | 1 |
| KCNT1-Related Epilepsy | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Omeprazole trials
How many clinical trials are testing Omeprazole?
16 current trials in our USA, Belgium, Poland, China, Australia, UK, Germany, Spain, Canada, Mexico, Singapore, France, Italy, Turkey, Brazil, South Korea, Taiwan and Denmark registers name Omeprazole as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Omeprazole trials recruiting patients?
Yes. 11 of the 16 trials are recruiting: 3 with sites in USA, 3 with sites in Belgium, 2 with sites in Poland, 2 with sites in China, 3 with sites in Australia, 2 with sites in UK, 2 with sites in Germany, 1 with sites in Spain, 2 with sites in Canada, 2 with sites in Mexico, 1 with sites in Singapore, 1 with sites in France, 1 with sites in Italy, 1 with sites in Turkey, 1 with sites in Brazil, 1 with sites in South Korea, 1 with sites in Taiwan and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Omeprazole clinical trials?
Hoffmann-La Roche (2), National University Hospital, Singapore (2), Eli Lilly and Company (1) and Gilead Sciences (1), among 14 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Omeprazole licensed in Ireland?
Yes. The HPRA medicines list includes 29 single-substance products containing Omeprazole, for example Losec Control 20 mg gastro-resistant tablets (Bayer Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Omeprazole shortage?
Not in the lists we track: Omeprazole has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Omeprazole works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Omeprazole works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Omeprazole (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.