Omeprazole: clinical trials recruiting now
4
Recruiting trials
8
Conditions studied
17
US states with sites
20
Countries
FDA drug label
- FDA-approved
- Yes. Omeprazole appears in the FDA drug-label database. Marketed as omeprazole.
- Drug class
- Proton Pump Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Proton Pump Inhibitors; Cytochrome P450 2C19 Inhibitors (as stated on the FDA label)
FDA-approved use
Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. — Dr. Reddy's Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-06-30 |
| CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle. — Dr. Reddy's Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-10-05 |
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| Subpotent Drug: Out of specification for assay — Bausch Health Companies, Inc. | Class II (FDA: may cause temporary or reversible harm) | Completed | 2024-02-02 |
| Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance. — Kremers Urban Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-09-16 |
Phase breakdown
Phase 1 3
Phase 3 1
Conditions being studied
| Condition | Trials |
|---|---|
| Active Ulcerative Colitis | 1 |
| Breast Cancer | 1 |
| Epilepsy | 1 |
| KCNT1-Related Epilepsy | 1 |
| Obesity | 1 |
| Type 2 diabetes | 1 |
| Ulcerative colitis | 1 |
| Weight Management | 1 |
Recruiting trials involving Omeprazole
- 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
- 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
- An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
- Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
Common questions
Is Omeprazole FDA-approved?
Yes, marketed as omeprazole.
How many recruiting trials involve Omeprazole?
4 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.