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
Research Report
A Comprehensive Monograph on Rabeprazole: Pharmacology, Clinical Efficacy, and Therapeutic Profile
Section 1: Introduction and Drug Identification
1.1. Overview and Classification
Rabeprazole is a second-generation proton pump inhibitor (PPI), a class of potent antisecretory agents used extensively in the management of acid-related disorders of the upper gastrointestinal tract.[1] Chemically, it is classified as a substituted benzimidazole, a structural characteristic shared by all members of the PPI class.[3] Its primary therapeutic function is to reduce the production of gastric acid, making it a cornerstone therapy for conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease (including gastric and duodenal ulcers), and pathological hypersecretory states like Zollinger-Ellison syndrome.[1]
The mechanism of action of rabeprazole involves the selective and irreversible inhibition of the gastric hydrogen-potassium adenosine triphosphatase (H+/K+-ATPase) enzyme system, commonly referred to as the proton pump.[1] This enzyme represents the final step in the pathway of gastric acid secretion by parietal cells. By blocking this pump, rabeprazole effectively suppresses both basal and stimulated acid production, independent of the stimulus.[2] Unlike older classes of acid-suppressing medications, rabeprazole does not exhibit anticholinergic or histamine H2-receptor antagonist properties, targeting the acid secretion pathway more directly and potently.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/26 | Not Applicable | Not yet recruiting | Voronoi, Inc | ||
2025/08/14 | Not Applicable | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
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 |
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 | |
REMEDYREPACK INC. | 70518-2590 | ORAL | 20 mg in 1 1 | 7/30/2025 | |
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 |
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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MYLAN-RABEPRAZOLE | Mylan Pharmaceuticals ULC | 02408392 | Tablet (Delayed-Release) - Oral | 10 MG | 7/10/2013 |
RABEPRAZOLE | sivem pharmaceuticals ulc | 02385449 | Tablet (Enteric-Coated) - Oral | 10 MG | 6/10/2012 |
RABEPRAZOLE EC | meliapharm inc | 02320614 | Tablet (Enteric-Coated) - Oral | 10 MG | 2/18/2010 |
TARO-RABEPRAZOLE EC | sun pharma canada inc | 02419793 | Tablet (Delayed-Release) - Oral | 20 MG | N/A |
ABBOTT-RABEPRAZOLE | BGP Pharma ULC | 02422638 | Tablet (Delayed-Release) - Oral | 10 MG | 10/17/2014 |
TARO-RABEPRAZOLE EC | sun pharma canada inc | 02419785 | Tablet (Delayed-Release) - Oral | 10 MG | N/A |
PMS-RABEPRAZOLE EC | 02310805 | Tablet (Enteric-Coated) - Oral | 10 MG | 6/3/2008 | |
APO-RABEPRAZOLE | 02345587 | Tablet (Enteric-Coated) - Oral | 20 MG | 5/1/2012 | |
RABEPRAZOLE EC | sanis health inc | 02356538 | Tablet (Enteric-Coated) - Oral | 20 MG | 11/23/2010 |
JAMP RABEPRAZOLE | 02415283 | Tablet (Delayed-Release) - Oral | 10 MG | 2/17/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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