Overview
Rabeprazole is an antiulcer drug in the class of proton pump inhibitors. It is a prodrug - in the acid environment of the parietal cells it turns into active sulphenamide form. Rabeprazole inhibits the H+, K+ATPase of the coating gastric cells and dose-dependent oppresses basal and stimulated gastric acid secretion.
Indication
For the treatment of acid-reflux disorders (GERD), peptic ulcer disease, H. pylori eradication, and prevention of gastroinetestinal bleeds with NSAID use.
Associated Conditions
- Duodenal Ulcer
- Gastric Ulcer
- Gastro-esophageal Reflux Disease (GERD)
- Heartburn
- Helicobacter Pylori Infection
- Non-erosive Reflux Esophagitis Disease (NERD)
- Vomiting
- Zollinger-Ellison Syndrome
- Develop NSAID-induced gastric ulcers
- Erosive reflux esophagitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/04 | Not Applicable | Recruiting | |||
2025/04/08 | Phase 1 | Recruiting | |||
2025/03/27 | Phase 1 | Recruiting | |||
2024/07/01 | Not Applicable | Not yet recruiting | |||
2024/05/16 | Phase 1 | Completed | |||
2024/03/29 | Phase 1 | Completed | TenNor Therapeutics Inc. | ||
2024/02/20 | Phase 1 | Completed | |||
2023/10/30 | Phase 1 | Completed | |||
2023/10/11 | Phase 2 | Completed | TenNor Therapeutics (Suzhou) Limited | ||
2023/10/11 | Phase 1 | Completed | TenNor Therapeutics (Suzhou) Limited |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Torrent Pharmaceuticals Limited | 13668-107 | ORAL | 20 mg in 1 1 | 8/10/2023 | |
| A-S Medication Solutions | 50090-3430 | ORAL | 20 mg in 1 1 | 8/1/2017 | |
| Chartwell RX, LLC | 62135-503 | ORAL | 20 mg in 1 1 | 5/2/2023 | |
| Bryant Ranch Prepack | 71335-1100 | ORAL | 20 mg in 1 1 | 8/2/2023 | |
| Woodward Pharma Services LLC | 69784-243 | ORAL | 20 mg in 1 1 | 3/31/2022 | |
| Lannett Company, Inc. | 62175-302 | ORAL | 20 mg in 1 1 | 8/18/2023 | |
| Proficient Rx LP | 71205-292 | ORAL | 20 mg in 1 1 | 11/1/2022 | |
| Physicians Total Care, Inc. | 54868-4185 | ORAL | 20 mg in 1 1 | 1/10/2011 | |
| Asclemed USA, Inc. | 76420-107 | ORAL | 20 mg in 1 1 | 6/26/2020 | |
| A-S Medication Solutions | 50090-1424 | ORAL | 20 mg in 1 1 | 7/7/2018 |
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 |
|---|---|---|---|---|---|
| PARIET TABLET 20 mg | SIN11233P | ENTERIC COATED TABLET | 20 mg | 11/29/1999 | |
| PARIET TABLET 10 mg | SIN11232P | TABLET, FILM COATED | 10 mg | 11/29/1999 | |
| ACILESOL GASTRO- RESISTANT TABLET 20MG | SIN14910P | TABLET, ENTERIC COATED | 20 mg | 12/18/2015 | |
| BEPRAZ GASTRO RESISTANT TABLETS 10MG | SIN15260P | TABLET, DELAYED RELEASE | 10mg | 6/7/2017 | |
| ACILESOL GASTRO- RESISTANT TABLET 10MG | SIN14909P | TABLET, ENTERIC COATED | 10 mg | 12/18/2015 | |
| Rabeprazole Sandoz Gastro Resistant Tablet 20mg | SIN14319P | TABLET, ENTERIC COATED | 20mg | 3/8/2013 | |
| BEPRAZ GASTRO RESISTANT TABLETS 20MG | SIN15259P | TABLET, DELAYED RELEASE | 20mg | 6/7/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20247094 | 化学药品 | 片剂 | 5/7/2024 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20233776 | 化学药品 | 片剂 | 6/21/2023 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20233808 | 化学药品 | 片剂 | 6/27/2023 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20243719 | 化学药品 | 片剂 | 7/23/2024 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20234002 | 化学药品 | 片剂 | 8/1/2023 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20234543 | 化学药品 | 片剂 | 11/21/2023 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20233483 | 化学药品 | 片剂 | 4/17/2023 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20249315 | 化学药品 | 片剂 | 11/15/2024 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20223845 | 化学药品 | 片剂 | 11/15/2022 | |
| Rabeprazole Sodium Enteric-coated Tablets | 国药准字H20040715 | 化学药品 | 片剂(肠溶片) | 2/26/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| RAZOLE GASTRO-RESISTANT TABLETS 20MG | N/A | N/A | N/A | 4/1/2019 | |
| RAZOLE GASTRO-RESISTANT TABLETS 10MG | N/A | N/A | N/A | 4/1/2019 | |
| PARIET TAB 20MG (ENTERIC-COATED) | N/A | N/A | N/A | 6/8/1999 | |
| PARIET TAB 10MG (ENTERIC-COATED) | N/A | N/A | N/A | 6/8/1999 |
TGA Drug Approvals
Help Us Improve
Your feedback helps us provide better drug information and insights.