Overview
Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .
Background
Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .
Indication
Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes: • 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 • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. • 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 adults
Associated Conditions
- Ankylosing Spondylitis (AS)
- Duodenal Ulcer
- Erosive Esophagitis
- Gastric Ulcer
- Gastro-esophageal Reflux Disease (GERD)
- Healing
- Heartburn
- Helicobacter Pylori Infection
- Osteoarthritis (OA)
- Rheumatoid Arthritis
- Upper GI Bleeding
- Zollinger-Ellison Syndrome
- Benign, active Gastric Ulcer
- Develop NSAID-induced gastric ulcers
- Hypersecretory conditions
- Multiple endocrine adenomas
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Not yet recruiting | Rehman Medical Institute - RMI | ||
2025/06/26 | Phase 4 | Recruiting | |||
2025/05/31 | Phase 4 | ENROLLING_BY_INVITATION | |||
2025/04/28 | Phase 1 | Recruiting | |||
2025/04/24 | Phase 4 | Not yet recruiting | |||
2025/02/12 | Phase 1 | Completed | Ahon Pharmaceutical Co., Ltd. | ||
2024/12/06 | Phase 2 | ENROLLING_BY_INVITATION | Medical University of Warsaw | ||
2024/11/15 | Phase 4 | Recruiting | |||
2024/11/13 | Phase 1 | Active, not recruiting | |||
2024/09/20 | Phase 1 | Recruiting | Karuna Therapeutics |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-7018 | ORAL | 20 mg in 1 1 | 5/11/2023 | |
| NorthStar Rx LLC | 16714-123 | ORAL | 40 mg in 1 1 | 6/15/2023 | |
| Unit Dose Services | 50436-8158 | ORAL | 20 mg in 1 1 | 11/12/2020 | |
| Bryant Ranch Prepack | 71335-0559 | ORAL | 10 mg in 1 1 | 2/18/2022 | |
| Quallent Pharmaceuticals Health LLC | 82009-023 | ORAL | 40 mg in 1 1 | 4/20/2023 | |
| Direct Rx | 61919-176 | ORAL | 20 mg in 1 1 | 5/31/2023 | |
| RedPharm Drug, Inc. | 67296-0706 | ORAL | 20 mg in 1 1 | 1/19/2022 | |
| ScieGen Pharmaceuticals, Inc. | 50228-363 | ORAL | 20 mg in 1 1 | 11/6/2023 | |
| Aurobindo Pharma Limited | 59651-001 | ORAL | 10 mg in 1 1 | 4/17/2023 | |
| Ranbaxy Laboratories Inc. | 63304-445 | ORAL | 40 mg in 1 1 | 8/25/2009 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OMICAP CAPSULE 20 mg | SIN09987P | CAPSULE | 20 mg | 9/11/1998 | |
| OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL | SIN16330P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg/ vial | 9/22/2021 | |
| OMESEC CAPSULE 20 mg | SIN11519P | CAPSULE | 20 mg | 5/16/2001 | |
| PROCEPTIN 20 CAPSULE 20 mg | SIN10186P | CAPSULE | 20 mg | 10/6/1998 | |
| ZENPRO CAPSULE 20MG (PHARMACY ONLY) | SIN15725P | CAPSULE | 20.00 mg | 6/25/2019 | |
| PENRAZOL ENTERIC COATED CAPSULE 20 mg | SIN11747P | CAPSULE | 20 mg | 12/26/2001 | |
| PROMESEC GASTRO-RESISTANT CAPSULES 20 MG (PHARMACY ONLY) | SIN16251P | CAPSULE, ENTERIC COATED | 20.000 mg | 6/28/2021 | |
| OMEZOLE 20 CAPSULE 20 mg | SIN11981P | CAPSULE | 20.00 mg | 6/5/2002 | |
| OMEPRADEX EC TABLET 20mg | SIN14019P | TABLET, ENTERIC COATED | 20 mg | 9/22/2011 | |
| OCID CAPSULE 20 mg | SIN11893P | CAPSULE | 20 mg | 4/24/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Omeprazole Sodium Enteric-coated Tablets | 国药准字H20041601 | 化学药品 | 片剂 | 6/29/2020 | |
| Omeprazole Sodium Enteric-coated Tablets | 国药准字H20010184 | 化学药品 | 片剂 | 7/21/2020 | |
| Omeprazole Sodium Enteric-coated Tablets | 国药准字H20051864 | 化学药品 | 片剂 | 7/21/2020 | |
| Omeprazole Sodium Enteric-coated Tablets | 国药准字H20031216 | 化学药品 | 片剂 | 8/14/2020 | |
| Omeprazole Magnesium Enteric-Coated Tablets | 国药准字HJ20181234 | 化学药品 | 片剂 | 2/13/2023 | |
| Omeprazole Magnesium Enteric-Coated Tablets | 国药准字HJ20181232 | 化学药品 | 片剂 | 2/13/2023 | |
| Omeprazole Magnesium Enteric-Coated Tablets | 国药准字H20243342 | 化学药品 | 片剂 | 3/12/2024 | |
| Omeprazole Magnesium Enteric-Coated Tablets | 国药准字H20067766 | 化学药品 | 片剂 | 3/26/2020 | |
| Omeprazole Magnesium Enteric-Coated Tablets | 国药准字HJ20181231 | 化学药品 | 片剂 | 2/13/2023 | |
| Omeprazole Magnesium Enteric-Coated Tablets | 国药准字H20010579 | 化学药品 | 片剂 | 3/26/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| GASEC-20 CAP 20MG (E.C. PELLETS) | N/A | N/A | N/A | 7/30/2002 | |
| GOMEC CAP 20MG (E.C. GRANULES) | N/A | N/A | N/A | 7/9/2002 | |
| EPRAZOLE CAP 20MG | N/A | N/A | N/A | 2/14/2003 | |
| OMIZEC CAP 20MG (ENTERIC COATED PELLETS) | N/A | N/A | N/A | 11/16/2009 | |
| OMEPRAZOLE CAP 20MG (ENTERIC COATED PELLETS) | N/A | N/A | N/A | 8/11/2006 | |
| LOMAC-20 CAP 20MG (E.C. GRANULES) | N/A | N/A | N/A | 8/19/2002 | |
| LOSCID GASTRO RESISTANT CAPSULES 20MG | N/A | N/A | N/A | 9/4/2017 | |
| OMEPRAZOLE JEAN-MARIE GASTRO-RESISTANT CAPSULES 20MG | N/A | N/A | N/A | 12/22/2022 |