Delving into the Latest Updates on Rabeprazole Sodium/Metronidazole/Amoxicillin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Clofezone, Rabeprazole, Rabeprazole Sodium/Amoxicillin Hydrate/Metronidazole

+ [4]

Target

Proton pump

Action

inhibitors

Mechanism

Proton pump inhibitors, Cell wall inhibitors

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

GastritisDuodenal UlcerHelicobacter pylori infection+ [2]

Inactive Indication

AsthmaDyspepsiaGastroesophageal Reflux+ [1]

Originator Organization

Eisai Co., Ltd.

Active Organization

Eisai Co., Ltd.

Inactive Organization

Eisai, Inc.

License Organization

Woodward Pharma Services LLC

Eisai Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

Japan (15 Aug 2013),

Duodenal UlcerHelicobacter pylori infectionPurpura, Thrombocytopenic, Idiopathic+ [1]

Regulation-

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Structure/Sequence

Molecular FormulaC18H21N3NaO3S

InChIKeyMLQSMKIAIQJZSZ-UHFFFAOYSA-N

CAS Registry117976-90-6

View All Structures (3)

As we know，Helicobacter pylori is closely related to many gastrointestinal diseases such as chronic gastritis, peptic ulcer disease,gastric carcinoma and gastric mucosa-associated lymphoid tissue lymphoma，as well as extra-digestive diseases such as urticaria and chronic obstructive pulmonary diseases and so on.The diagnosis of H. pylori infection is based on invasive methods requiring endoscopy and biopsy(e.g. histology, culture, rapid urease test, PCR) or on non-invasive methods (e.g. serology, 13C urea breath test, stool antigen test).Histology has the highest specificity among the others,and also allows us to determine the underlying disease and perform antibiotic sensitivity testing.Serological tests are widely available and more appropriate for epidemiological studies, their main weakness for clinical use is low specificity.The 13C urea breath test is the most accurate method in patients irrespective of age.Stool antigen testing,as a promising method, is easy to perform, and its accuracy may be improved by the use of monoclonal antibodies recently proposed for capturing H. pylori antigen in stool specimen.Sensitivity and specificity, usefulness,and limitation of tests should be considered for selection of detection methods of H. pylori. Our objective is to review the current methods that are used for the detection of H. pylori infection among patients with chronic atrophic gastritis.Except that,patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy.

Start Date28 Jun 2021

Sponsor / Collaborator

The Second Affiliated Hospital Zhejiang University

NCT04565574

/ CompletedPhase 1

An Open-Label, Single-Dose Study to Assess the Effect of Food Intake and Drug-Drug Interactions of E7090 When Co-administered With Rabeprazole (Gastric Acid-Reducing Agent), or Rifampin (Strong CYP3A Inducer) in Healthy Subjects

This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A is to evaluate the effect of food on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole (a gastric acid-reducing agent) on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part C is to evaluate the effects of rifampin (a strong Cytochrome P450 3A [CYP3A] inducer) on pharmacokinetics (PK) of single oral doses of E7090 in healthy participants.

Start Date16 Oct 2020

Sponsor / Collaborator

Eisai Co., Ltd.

100 Clinical Results associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

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100 Translational Medicine associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

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100 Patents (Medical) associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

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1,263

Literatures (Medical) associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

01 Sep 2026·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

The effect of pH stability and aqueous solubility on the oral bioavailability of a novel antileishmanial agent

Article

Author: Xie, Huan ; Adebusuyi, Tolulope ; Kaur, Manvir ; Liang, Dong ; Nigro, Maria Rincon ; Ma, Jing ; Olaleye, Esther

OJT007 is a novel drug class with potent antiproliferative effects against Leishmania Major. The drug is amphoteric with a key basic amine pKa of 5.8 and acid liable. Pre-systemic metabolism in gastric acidic compartment is suspected as a major factor for its low oral bioavailability. To validate this biopharmaceutical assumption, we evaluated in vitro stability and solubility profiles of OJT007 in various buffers (pH 1.2-7). We further conducted a pharmacokinetic drug-drug interaction study where OJT007 was orally administered alone or following pre-treatment of rabeprazole, a prescription proton pump inhibitor that reduces stomach acid using rat as an animal model. The in vitro degradation of OJT007 was rapid at pH 1.2-3 with less than 50% drug remaining within 30 min. Solubility of OJT007 was also pH-dependent with a solubility of 31.3 µg/mL at pH 1.2 and practically insoluble at pH above 6. Interestingly in the in vivo studies, there were approximately 40% reduction in the mean maximum plasma drug concentration (C_max) and the mean area under the plasma concentration versus time curve (AUC_0-∞) in the rat group pre-treated with rabeprazole as compared to OJT007 alone. As opposed to our initially hypothesized, OJT007 degradation under gastric acidic pH was not a major factor controlling oral bioavailability of the drug. Instead, low solubility at a higher pH might have contributed to the observed low bioavailability. The findings illustrate that optimizing oral bioavailability for OJT007 requires formulation strategies that simultaneously address solubility at intestinal pH and stability in the stomach.

01 Sep 2026·ACTA TROPICA

Repurposing the proton pump inhibitor "Rabeprazole sodium" in the treatment of acute experimental murine toxoplasmosis

Article

Author: Rashed, Hoda Adel ; Hussien, Hadeer Elsayed Abdelmoneam ; Kolaib, Nourhan Mohamed ; Gomaa, Maha Mohamed ; Sadaka, Hayam Abdel Moneim

Toxoplasmosis is a major health concern with serious consequences in immunocompromised patients and pregnant women. The currently available anti-Toxoplasma therapies have significant limitations including toxicity and emerging resistance. Therefore, there is an urgent need for safe and effective alternative drugs. Repurposing of proton pump inhibitors (PPI) represents a promising strategy because of their reported antiparasitic activities. This study aimed to evaluate the potential therapeutic effect of rabeprazole sodium, a PPI, in a murine model of acute toxoplasmosis in comparison with trimethoprim-sulfamethoxazole (TMP-SMZ). The employed mice were allocated into five groups. Uninfected control, Infected untreated, Infected DMSO-treated, Infected TMP-SMZ-treated, and Infected rabeprazole-treated. Two regimens of rabeprazole were applied; seven-day and ten-day regimens. The efficacy of drugs was assessed through various parameters: parasite load in peritoneal fluid and tissue impression smears, tachyzoite viability rate, scanning and transmission electron microscopy, histopathological and immunohistochemical studies and assay of cytoplasmic and apicoplast triose phosphate isomerase (TPI) enzyme activity. The ten-day regimen of rabeprazole elicited a statistically significant decrease in parasite count in peritoneal fluid, liver and spleen impressions with reductions of 92.16%, 93.83% and 90.91%, respectively. Additionally, tachyzoite viability and TPI activity were significantly affected, and numerous ultrastructural deformities were captured. Favorably, it has obviously ameliorated the tissue pathology through anti-apoptotic impacts and anti-inflammatory properties. To our knowledge, this is the first in vivo study to repurpose rabeprazole against acute toxoplasmosis. In this context, rabeprazole demonstrated superior efficacy to TMP-SMZ enforcing its potential as a promising safe, alternative therapeutic regimen for toxoplasmosis.

01 Aug 2026·JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Development of a novel rabeprazole modified release formulation to reduce the dosing frequency: A trial and triumph with physiologically based biopharmaceutics modeling

Article

Author: Naidu, Venkat Ramana ; Chaudhari, Sangmesh Mallikarjun ; Boddu, Rajkumar ; Kambam, Veena ; Maddukuri, Harika ; Saini, Anuj Kumar ; Singh, Sanjay Kumar ; Choudhury, Anup Avijit ; Kollipara, Sivacharan ; Khan, Sohel Mohammed

Advanced in silico tools, such as physiologically based biopharmaceutics models (PBBM) and physiologically based pharmacokinetic models (PBPK), play a pivotal role in model-informed formulation development (MIFD). In the present study, these methodologies were utilized in the development of a novel rabeprazole modified-release (MR) formulation for improved patient compliance by reducing the dosing frequency relative to existing delayed-release (DR) formulation. A MR formulation containing combination of delayed release and pulsatile release components was designed based on the hypothetical dissolution targets. A PBBM was first established using literature-derived clinical data and used to simulate the performance of formulations with varied dissolution profiles. Initial MR formulation prototypes (once a day) were evaluated in pilot-1 bioequivalence (BE) study against reference formulation (twice a day) but results indicated infra bioequivalence outcome. After pilot-1 study, the formulation and the dissolution method were optimized and then model was refined to predict the pilot 1 outcomes. The validated model was then employed to select suitable pilot-2 prototypes and to prospectively predict their BE outcomes under fasted and fed conditions. The predicted BE ratios were in good agreement with the observed pilot-2 study results. Therefore, the same model was used to make prospective predictions with increased subjects to understand the in vivo performance of pivotal test formulation and lead to the successful bioequivalence outcome, product commercialization, ultimately aiding in increased patient compliance. This work highlights the value of a model-informed strategy in accelerating formulation optimization, reducing development timelines and costs, and strengthening decision-making within pharmaceutical development programs.

5

News (Medical) associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

02 Jun 2025

·www.eisai.com

Eisai to Launch “Pariet® S,” the First Proton Pump Inhibitor RX-to-OTC in Japan

For Print June 2, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the launch of “Pariet® S” (pharmaceutical requiring guidance), which is highly effective in alleviating severe heartburn and stomach pain caused by gastric acid reflux, at pharmacies and drugstores throughout Japan. 1 "Pariet S" is the first proton pump inhibitor (PPI 2) to receive manufacturing and marketing approval as an over the counter (OTC) medicine in Japan. Rabeprazole sodium, in an amount equivalent to that used in the prescription product 3, works directly on the proton pumps that produce stomach acid, effectively alleviating severe heartburn caused by gastric acid reflux and stomach pain due to excessive acid secretion. The medicine comes in small, easy-to-swallow tablets, with a once-daily dosage providing 24-hour relief. Rabeprazole sodium, the active ingredient in “Pariet S”, is a PPI developed at Eisai’s Tsukuba Research Laboratories. The medicine was first launched in Japan in 1997 as a prescription pharmaceutical under the brand name “Pariet” and has since been approved more than 100 countries worldwide. It is widely prescribed to people struggling with acid-related disorders. In recent years, there is a tendency for increased stomach acid secretion due to disrupted eating habits, stress, and a decline in the infection rate of Helicobacter pylori. Moreover, the number of individuals experiencing gastric acid reflux has grown, driven by age-related weakening of the lower esophageal sphincter. Eisai will introduce “Pariet S” as a new treatment option in the OTC gastric medication market, aiming to alleviate sever heartburn and discomfort caused by gastric acid related conditions, and strongly support people in the daily living domain who wish for a comfortable and secure daily life. For further details, please refer to the product’s website for details about "Pariet S" (Japanese only) https://www.eisai.jp/products/pariet/pariets 1 "Pariet S" is classified as a drug that requires a pharmacist’s guidance at the time of sale 2 Proton Pump Inhibitor suppresses gastric acid secretion by inhibiting the “proton pump” which is the final step in the secretion process. 3 Contains rabeprazole10mg per tablet Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors] Product Outline 1. Product Name: “Pariet® S” (RX-to-OTC switch, pharmaceutical requiring guidance) 2. Ingredients: Per daily dose of one tablet: rabeprazole sodium 10mg Inactive Ingredients: Magnesium oxide, talc, hydroxy propyl cellulose, D-mannitol, ethylcellulose, carnauba wax, carmellose calcium, glycerin esters of fatty acids, titanium oxide, iron sesquioxide, magnesium stearate, hypromellose phthalate 3. Indications and Usage: Stomach pain, heartburn, and bloating (This medicine contains a proton pump inhibitor which suppresses stomach acid secretion.) 4. Dosage and Administration: Adults (15 years and older): 1 tablet once daily. Do not use this medicine consecutively for more than two weeks. 5. Packaging and Recommended Retail Price (excluding tax): Packaging: 6 tablets, Recommended retail price: 1,480 yen 6. Manufactured and marketed by: Eisai Co., Ltd. Inactive Ingredients: Magnesium oxide, talc, hydroxy propyl cellulose, D-mannitol, ethylcellulose, carnauba wax, carmellose calcium, glycerin esters of fatty acids, titanium oxide, iron sesquioxide, magnesium stearate, hypromellose phthalate Full text

Drug Approval

29 Mar 2025

·pharma.economictimes.indiatimes.com

103 drug samples fail CDSCO quality test, popular brand Telma H flagged as spurious

New Delhi: During its monthly quality review, the drug regulatory body identified 103 drug samples as ‘Not of Standard Quality’ ( NSQ ) and flagged a sample of the popular brand Telma H as ‘spurious.’ Of the 103 drug samples that failed to meet the quality standards, 47 were identified by central drug laboratories, while the remaining 56 were identified by state drug laboratories in the country. The drug sample that has been labeled as “spurious” is Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg), a popular brand prescribed for high blood pressure patients. As per the Union Health Ministry note, the sample was picked from West Bengal. As per the February drug alert issued by the Central Drugs Standard Control Organisation (CDSCO), the sample was manufactured in 2022 and the reason for the drug test failure as notified in the alert suggests that the sample “does not conform to I.P.” (Indian Pharmacopoeia). The branded generic drug is marketed by Glenmark and, as per an analysis from market research firm Pharmarack, it features among the top 50 brands in the country, with a moving annual total (MAT) value of around ₹447 crore. Regarding the identified spurious drug sample, the Health Ministry, in its quality review announcement, stated that the sample is “made by an unauthorized manufacturer using a brand name owned by another company. The matter is under investigation and action.” CDSCO, in its drug quality alert, has remarked that the product is purported to be spurious; however, the same is subject to the outcome of the investigation. The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The 47 NSQ samples identified by the central laboratories include Rabeprazole Tablets manufactured by Martin & Brown BioSciences Pvt. Ltd.; Paracetamol & Diclofenac Sodium Tablets manufactured by I.G. PHARMA LTD.; and Telmisartan Tablets IP by Orison Pharma International, among 44 others. Whereas, the list from state laboratories comprises Calcium & Vitamin D3 Tablets manufactured by Affy Parenterals Vill.; Phenytoin Tablets by Jackson Laboratories; and Cloprostenol Injection by Monatt Biotech, including 53 others. According to CDSCO, a drug shall be deemed spurious if it is manufactured under a name belonging to another drug; if it is an imitation of, or a substitute for, another drug; if it resembles another drug in a manner likely to deceive; or if it bears upon its label or container the name of another drug, among other provisions defined under Section 17-B of the Drugs and Cosmetics Act, 1940. Whereas drugs that fail to meet quality standards or specifications are notified as NSQ, a term defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. By Abhijeet Singh ,

13 Jun 2024

·www.pharmaindustrial-india.com

Akums Launches Rabeprazole + Levosulpiride SR Capsules

Akums Drugs & Pharmaceuticals Ltd. announced that it has launched Rabeprazole + Levosulpiride SR Capsules. Approved by the Drug Controller General of India (DCGI), the company claims this new formulation aims to enhance relief for patients suffering from gastrointestinal tract (GIT) disorders. GERD, or gastro-oesophageal reflux disease, is a debilitating condition characterised by the reflux of stomach contents into the oesophagus, leading to troublesome symptoms and potential complications. With GERD often dubbed as chronic acid reflux, its prolonged presence not only impacts the quality of life but also poses risks of serious health complications, including stomach and esophageal cancer. “Rabeprazole sodium, a potent antisecretory compound, selectively inhibits gastric acid secretion by targeting the H+ and K+ ATPase at the surface of gastric parietal cells. It has demonstrated efficacy in treating gastric and duodenal ulcers, as well as GERD. Complementing rabeprazole, Levosulpiride, the levo-enantiomer of sulpiride, exhibits significant central antidopaminergic activity and antiemetic effects,” the company said in a statement. Its peripheral anti-dopaminergic action modulates the motor activity of the upper digestive tract, making it valuable in gastro-enterology, it claimed. “We are excited to introduce a solution for patients suffering from GERD and related gastrointestinal disorders. GERD diagnosis and treatment rely on symptom management and acid suppression therapies. Our Rabeprazole + Levosulpiride SR Capsules aim to offer an effective remedy, ease symptoms, enhance gastrointestinal function, and boost patients’ overall well-being. Levosulpiride offers rapid relief and better healing outcomes with fewer side effects, elevating the overall treatment experience,” Arushi Jain, Director, Akums Drugs & Pharmaceuticals Ltd. said in a statement. Each hard gelatin capsule contains Rabeprazole Sodium IP 40 mg (as enteric-coated form) and Levosulpiride 75 mg (as uncoated sustained-release form). The recommended dosage is one capsule once daily or as directed by a physician.

Drug Approval

100 Deals associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

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External Link

KEGG	Wiki	ATC	Drug Bank
D07263 D10520	Rabeprazole Sodium/Metronidazole/Amoxicillin	J01CR02	DB01129

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastritis	Japan	Eisai Co., Ltd.	21 Nov 2013
Duodenal Ulcer	Japan	Eisai Co., Ltd.	15 Aug 2013
Helicobacter pylori infection	Japan	Eisai Co., Ltd.	15 Aug 2013
Purpura, Thrombocytopenic, Idiopathic	Japan	Eisai Co., Ltd.	15 Aug 2013
Stomach Ulcer	Japan	Eisai Co., Ltd.	15 Aug 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	United States	Eisai, Inc.	01 Sep 2002
Gastroesophageal Reflux	Phase 3	United States	Eisai, Inc.	01 Sep 2002
Dyspepsia	Phase 2	Japan	Eisai Co., Ltd.	01 Apr 2010
Nasopharyngeal Diseases	Phase 2	United States	Eisai, Inc.	01 Jun 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2019	Not Applicable	Helicobacter pylori infection	-	Quadruple therapy 10 days (QT-10)	twssovlbgr(lbfrlduidl) = The overall incidence of AEs was also significantly lower in the OST-14 group, compared to QT-10 and QT-14 groups (21.2%, 37.2% and 41.6% respectively, p=0.02 ) bgawhlpuit (kctgwgfgoz )	Positive	01 Oct 2019
NCT02135107 (EXTEND study \| EXTEND, CTgov)	Phase 3	Gastroesophageal Reflux	517	Rabeprazole (Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily)	jkgfhkeawb = fqyczqpkat diwyrpyoil (pawdikxwge, lydmvczvnj - jxwlcxbvli) View more	-	19 Nov 2018
				Rabeprazole (Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily)	jkgfhkeawb = ahfurytmbu diwyrpyoil (pawdikxwge, oxqcujcyms - yajcenxsac) View more
NCT01398410 (CTgov)	Phase 2/3	Stomach Ulcer	405	Rabeprazole (Rabeprazole 5 mg)	ltzngufrnh = bwfsupozok yssqajebud (sdkztvcsxa, astyegyomg - zsedocmoyp) View more	-	16 Nov 2015
				Rabeprazole (Rabeprazole 10 mg)	ltzngufrnh = hbicoxpnkk yssqajebud (sdkztvcsxa, rjpniqblix - azuewoxkfq) View more
NCT01922765 (Pubmed \| World J Gastroenterol)	Phase 4	Helicobacter pylori infection	680	Clarithromycin-based triple therapy	qgkjbnqntm(eddcjtqsne) = hshvsjbozc dxtnpbgxgh (jikgverilj )	-	01 Jan 2015
				Metronidazole-based triple therapy	qgkjbnqntm(eddcjtqsne) = youyrumdtd dxtnpbgxgh (jikgverilj )
NCT00539240 (CTgov)	Phase 2/3	Pain \| Gastroesophageal Reflux	236	placebo+Rabeprazole (Arm 1)	drbdxxosrn(ergdgpxhyn) = svkbtkhyxc vnylvgqoin (lxyktqriiz, 0.9) View more	-	18 Aug 2014
				placebo+Rabeprazole (Arm 2)	drbdxxosrn(ergdgpxhyn) = dnoopfwfje vnylvgqoin (lxyktqriiz, 2.2) View more
NCT01089543 (SAMURAI \| E3810-J081-204, CTgov)	Phase 2	Dyspepsia	338	Rabeprazole (Rabeprazole 10 mg)	olqxdewqld = obrdrxxctt toettlllwd (yrcwnqvxhr, gmdodzvorp - pqftgmevvt) View more	-	19 Nov 2013
				Rabeprazole (Rabeprazole 20 mg)	olqxdewqld = xesqokpfpd toettlllwd (yrcwnqvxhr, twbcwfahsw - rybypzpkif) View more
NCT01089543 (SAMURAI, Pubmed \| Aliment Pharmacol Ther)	Phase 2	Dyspepsia	392	Rabeprazole 20 mg	qcjsxcbbzk(poimyexqti) = milxvpjcdg dmhofprfca (xqfamstltf )	Positive	01 Oct 2013
				Placebo	qcjsxcbbzk(poimyexqti) = ipqillykmh dmhofprfca (xqfamstltf )
NCT00787891 (CTgov)	Phase 3	Gastroesophageal Reflux	127	Rabeprazole Sodium (Rabeprazole Sodium 0.5 mg/kg)	owacoigybs = jgscmbhwyt swzdklrvzb (zgxmuqdymh, pllghetryz - hjjqnfccag) View more	-	11 Oct 2012
				Rabeprazole Sodium (Rabeprazole Sodium 1.0 mg/kg)	owacoigybs = vqlbvkektr swzdklrvzb (zgxmuqdymh, qulsghiqiv - ibnzjkbead) View more
NCT00165841 (CTgov)	Phase 2	Gastroesophageal Reflux	200	Rabeprazole 20 mg (Rabeprazole 20 mg)	goavbuklbf(rypynfoxcb) = ezkmpdlyfd davkprqjua (lfaarjrled, 14.39) View more	-	03 Dec 2009
				Rabeprazole 20 mg (Placebo)	goavbuklbf(rypynfoxcb) = reigvqfimo davkprqjua (lfaarjrled, 29.93) View more