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Rabeprazole

Generic Name
Rabeprazole
Brand Names
Aciphex, Pariet
Drug Type
Small Molecule
Chemical Formula
C18H21N3O3S
CAS Number
117976-89-3
Unique Ingredient Identifier
32828355LL

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

Published: Jul 30, 2025

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]

Continue reading the full research report

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.

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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