TheraRadar
Data updated: May 26, 2026

RABEPRAZOLE SODIUM

Trial Activity: Declining 8 active trials
Gastrointestinal Approved 2013-11-08

Rabeprazole sodium is a proton pump inhibitor indicated in adults for the healing and maintenance of healing of erosive or ulcerative gastroesophageal reflux disease (GERD), the treatment of symptomatic GERD, and the short-term healing of duodenal ulcers. It is also used in combination regimens for *H. pylori* eradication to reduce the risk of duodenal ulcer recurrence and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Additionally, it is indicated for the short-term treatment of symptomatic GERD in adolescent patients 12 years of age and older.

Source: FDA Label • CHARTWELL RX
Jump to: Indications Approvals Trials Competitors Safety Patents

How RABEPRAZOLE SODIUM Works

Rabeprazole sodium belongs to the substituted benzimidazole class of antisecretory compounds. It suppresses gastric acid secretion by inhibiting the gastric H+, K+ ATPase enzyme (the proton pump) at the secretory surface of the gastric parietal cell. As a prodrug, rabeprazole is accumulated and protonated within the acidic environment of the parietal cells, where it is transformed into an active sulfenamide. This active form covalently binds to the enzyme, blocking the final step of gastric acid secretion.

Source: FDA Label

Development Insights

Eisai Co., Ltd. conducting 17 trials (25%)
34 indications explored (Broad Platform)
→ healthy (14 trials)
→ healthy volunteers (7 trials)
→ healthy volunteer (7 trials)
5
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2013-11-08
Routes
ORAL
Dosage Forms
TABLET, DELAYED RELEASE

Companies

CHARTWELL RX Aurobindo Pharma ALKEM LABS LTD Dr. Reddy's PHARMOBEDIENT LANNETT CO INC Teva TORRENT AMNEAL PHARMS RUBICON RESEARCH
Active Ingredient: RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
76 FDA actions from 2013 to 2024
Nov 2024 SUPPL
Label · Labeling
Apr 2024 SUPPL
Label · Labeling
Nov 2023 SUPPL
Label · Labeling

What RABEPRAZOLE SODIUM Treats

6 indications

RABEPRAZOLE SODIUM is approved for 6 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Erosive or ulcerative gastroesophageal reflux disease (GERD)
  • Maintenance of healed GERD
  • Symptomatic GERD
  • Duodenal ulcers
  • Helicobacter pylori eradication
  • Pathological hypersecretory conditions (including Zollinger-Ellison syndrome)
Source: FDA Label

RABEPRAZOLE SODIUM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

10

Same target(s) AND same indication — head-to-head.

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Baxter
2024 4 indic.
KONVOMEP
AZURITY
2022 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

TECHNETIUM TC-99M SULFUR COLLOID KIT
JUBILANT
2023 4 indic.
VOQUEZNA
PHATHOM PHARMACEUTICALS
2023 4 indic.
Unlock 16 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

67 trials
Trial Sponsor ID Phase Status Title
NCT07329972 GP46367 Ph 1 completed A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants
NCT07141381 VRN110755-001 Ph 1 completed A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
NCT07471867 EZ-STAR 9-2025-0234 Ph 4 recruiting Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention
NCT06916143 27274 J5C-MC-FOAH, DCE853105 Ph 1 active not recruiting Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid
NCT06899061 D9723C00002 2024-513692-41-00 Ph 1 active not recruiting Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
NCT07284173 C6231005 Ph 1 active not recruiting A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Healthy Chinese Adults.
NCT05380947 results posted 1479-0003 2022-000268-23 Ph 1 completed A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
NCT05407675 results posted CA099-003 Ph 1, Ph 2 completed A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
NCT07122024 Keverprazan Helicobacter pylo FK2024-6926 Ph 4 recruiting Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
NCT06417229 CA228-1011 Ph 1 completed Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants
NCT02475161 CR107627 42847922EDI1006 Ph 1 completed A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Participants
NCT05899829 results posted 221853 BUS-P1-11 Ph 1 completed Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant
NCT06054464 PMV-586-104 Ph 1 completed A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
NCT05918822 results posted TAK-620-1024 Ph 1 completed A Study of Maribavir Pediatric Formulation in Healthy Adult Participants
NCT06264440 283HV104 Ph 1 completed A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants
NCT03237741 GP39778 2017-000299-27 Ph 1 completed Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants
NCT06076694 results posted TNP-2198-06 Ph 2 completed Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
NCT06076681 results posted TNP-2198-04 Ph 1, Ph 2 completed A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
NCT05930119 2023-453-00CH1 Ph 1 completed HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study
NCT02135107 results posted E3810-J081-311 Ph 3 completed A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
NCT05330858 ESK-001-002 Ph 1 completed Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
NCT04564612 257HV105 2020-000682-16 Ph 1 completed Study of BIIB091 Formulations in Healthy Participants
NCT05571787 2022-523-00US1 Ph 1 completed HMPL-523 Food Effect and Proton Pump Inhibitor Study
NCT02986685 rRE KY-20162096-1 Ph 4 withdrawn Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
NCT05014334 KY20212155-C-1 Ph 4 completed Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication
NCT04697186 KY20202119 Ph 4 completed Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
NCT01287091 PIM4930g Ph 1 completed A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
NCT03530995 results posted KD025-107 2018-000316-16 Ph 1 completed Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers
NCT04944771 D3614C00005 2021-000836-74 Ph 1 completed Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants
NCT05061732 B2021-376 Ph 4 recruiting Helicobacter Pylori Eradication and Follow-up
NCT04622358 AD-214PK/PD-02 Ph 1 completed A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
NCT03464058 BOS172767-01 2017-004002-18, QCL118174 Ph 1 completed Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
NCT03979248 IM011-090 2019-001193-28 Ph 1 completed A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants
NCT04489797 D822FC00008 Ph 1 completed A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants
NCT04503629 3571-DU-2001 Ph 2 completed A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
NCT02655614 GN29823 2017-002931-41 Ph 1 completed A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis
NCT02638584 HUMC-ILA01 Ph 4 completed Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.
NCT04211545 CC-92480-CP-002 U1111-1242-7394 Ph 1 completed Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
NCT02699710 QCL117578 GP29832 2015-002471-25, QCL117578 Ph 1 completed Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
NCT03290703 GP39619 2017-000752-26 Ph 1 completed A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
NCT03789032 AKB-6548-CI-0033 Ph 1 completed Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
NCT03220191 A5481091 Ph 1 completed Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
NCT03130556 B1371026 B1371026 Ph 1 completed A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation
NCT02463643 Z215-01 Ph 2 completed To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
NCT01277718 results posted MEK4954g Ph 1 completed A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
NCT01408186 APH Study Ph 3 completed ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA
NCT00999128 GDC4740g Ph 1 completed A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
NCT01772290 GP28465 Ph 1 completed A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib
NCT02037477 results posted TAK-438/CPH-010 U1111-1152-3926, NCT02037477 Ph 3 completed Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)
NCT02569554 B7461008 2015-003416-21, PPI STUDY Ph 1 completed PPI And Food Effect Study For PF-06463922 In Healthy Volunteers

Showing 50 of 67 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RABEPRAZOLE SODIUM FDA Label Details

Indications & Usage

FDA Label (PDF)

RABEPRAZOLE SODIUM is indicated for the treatment of Erosive or ulcerative gastroesophageal reflux disease (GERD); Maintenance of healed GERD; Symptomatic GERD; Duodenal ulcers; Helicobacter pylori eradication; Pathological hypersecretory conditions (including Zollinger-Ellison syndrome).

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Data Sources

FDA Approval: ANDA078964 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment