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 FormulaC16H21N3O6S

InChIKeyAIPFZZHNBUVELL-YWUHCJSESA-N

CAS Registry61336-70-7

View All Structures (3)

Author: Künze, Georg ; Geisslinger, Gerd ; Buchholz, Mirko ; Metzger, Marco ; Köhl, Ulrike ; Schmidt, Johannes R ; Windshügel, Björn ; Neser, Christina ; Haupt, Janine ; Biermann, Melina K ; Neurath, Markus F ; Siegmund, Britta ; Lehmann, Jörg ; Kalkhof, Stefan ; Müller, Claudia ; Claussen, Carsten ; Scholz, Ulrike ; Wiltzsch, Vivien ; Schiefke, Ingolf ; Keminer, Oliver ; Oliveira da Rocha, Gustavo Henrique ; Zdzieblo, Daniela ; Pliushcheuskaya, Palina

The aryl hydrocarbon receptor (AhR) was shown to be an important regulator of inflammatory processes at epithelial barriers, and is thus considered a therapeutic target for several chronic inflammatory diseases, such as inflammatory bowel disease. We aimed to identify and validate new AhR agonists that sustainably attenuate intestinal inflammation. Using a high-throughput luciferase reporter gene assay, 90 AhR ligands were identified out of 7448 approved and investigational drugs. Out of these, 15 AhR ligands were selected based on substance class, half maximal effective concentration, known toxicity and pharmacokinetic/pharmacodynamic profiles, and preclinical/clinical evaluation status for other indications. While Febuxostat, Nitazoxanide, Rabeprazole, 2-(1'H-indole-3'-carbonyl)-thiazole-4-carboxylic acid methyl ester, 3-Indolepropionic acid, and Indirubin, were already known as AhR agonists, Nabumetone, Teriflunomide, Timapiprant/OC000459, and Caffeic acid phenylethyl ester have not yet been directly described in this context. Six compounds (Daidzein/Equol, as well as compounds no. 19, 22, 49, and 64, not yet disclosed due to pending patent applications) were newly described as AhR agonists. Hit compounds were studied in silico for their molecular interactions with AhR and in vitro for potential immunotoxicity and their ability to induce interleukin (IL)-10 and/or to suppress IL-1β in murine macrophages without significant cytochrome P450 1A1 induction in Caco-2 cells. Five compounds that met these criteria were functionally tested using organoid-based Transwell®-like models derived from gut biopsies. Five candidates restored the epithelial barrier, as evidenced by increased transepithelial electrical resistance and induction of the tight junction proteins claudin-1/-2 and occludin, while exhibiting anti-inflammatory effects, i.e., decreased expression of toll-like receptor 4. Out of these, one compound was selected for future in vivo preclinical studies.

01 Sep 2025·AMERICAN HEART JOURNAL

Potassium-competitive acid blocker vs proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial

Article

Author: Lee, Jinho ; Park, Hwan-Cheol ; Kim, Byeong-Keuk ; Park, Han-Su ; Kim, Sang Min ; Choi, Kee Don ; Park, Seung-Jung ; Lee, Jong-Young ; Jin, Eun-Sun ; Yang, Tae-Hyun ; Lim, Young-Hyo ; Kim, Weon ; Yoon, Myeong-Ho ; Her, Sung-Ho ; Kim, Sang-Hyun ; Lee, Wang Soo ; Lee, Junghoon ; Park, Hanbit ; Hong, Soon Jun ; Suh, Jung-Won ; Kwon, Sung Uk ; Kang, Do-Yoon ; Park, Kyoung-Ha ; Nam, Chang-Wook ; Shin, Eun-Seok ; Ahn, Jung-Min ; Park, Duk-Woo ; Kang, Se Hun ; Yoon, Yong-Hoon ; Choi, Eue-Keun ; Choi, Young Jin ; Jeong, Jin-Ok

BACKGROUND:

Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI.

DESIGN:

The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes.

RESULTS:

As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027.

CONCLUSION:

PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding.

CLINICAL TRIAL REGISTRATION:

Potassium-Competitive Acid Blocker versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High GastroIntestinal Bleeding Risk Receiving Antithrombotic Therapy (PROTECT-HBR): NCT04416581.

01 Aug 2025·JOURNAL OF INFECTION

Lactiplantibacillus plantarum MH-301 reduces Helicobacter pylori treatment-related adverse events via gut-vaginal axis: A randomized, double-blind, placebo-controlled trial

Article

Author: Liu, Hui ; Liu, Zhiguo ; Gan, Lihong ; Liu, Peng ; Zheng, Li ; Chen, Tingtao ; Zhang, Kaige ; Fang, Nian ; Zeng, Yuyu ; Han, Xiaoni

BACKGROUND:

Adverse events and microbiota dysbiosis resulting from Helicobacter pylori eradication therapy have become increasingly evident. This study aims to investigate the adjunctive therapeutic effects of Lactiplantibacillus plantarum MH-301 in H. pylori eradication therapy, as well as its effects on the gut and vaginal microbiota.

METHOD:

257 sexually active, premenopausal women aged 18-50 years, diagnosed with H. pylori infection alongside chronic gastritis, were randomly allocated to undergo either bismuth-containing quadruple therapy (amoxicillin, furazolidone, potassium bismuth citrate, rabeprazole) combined with probiotics (L. plantarum MH-301) or a placebo for 14 days. Stool samples and vaginal swabs were collected before and after treatment to facilitate high-throughput sequencing analysis.

RESULT:

The probiotic group exhibited lower incidences of bloating (10.2% vs 19.4%, P=0.037), constipation (2.3% vs 7.8%, P =0.048), and excessive vaginal discharge (3.1% vs 9.3%, P=0.040), and showed better treatment tolerability compared to the placebo group (P<0.05), although no statistically significant difference in eradication rates between the two groups. High-throughput sequencing revealed that H. pylori eradication therapy led to a decrease in the relative abundance of Prevotella in the gut microbiota, and an increase in Streptococcus and Haemophilus. In the vaginal microbiota, Lactobacillus decreased while Gardnerella increased. Compared to the placebo group, the probiotic group showed a higher relative abundance of Megamonas, Prevotella, and Lactobacillus in the gut microbiota, and lower levels of Streptococcus and Haemophilus. In the vaginal microbiota, Gardnerella was significantly lower (P<0.05). Correlation analysis revealed a positive association between gastrointestinal and vaginal adverse events, and a positive correlation of Lactobacillus in both gut and vaginal microbiota (P<0.05).

CONCLUSION:

This study clinically demonstrates for the first time that L. plantarum MH - 301 may reduce H. pylori treatment - related adverse events via gut - vaginal axis. In addition, microbiota modulation may be the mechanism through which it exerts its clinical efficacy.

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
-	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)	uovrvgqybi(trrqzftkic) = 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 ) zsdmqkklya (eurfhylqki )	Positive	01 Oct 2019
NCT02135107 (EXTEND, CTgov)	Phase 3	Gastroesophageal Reflux	517	Rabeprazole (Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily)	fhebvpkivg = erpzvgtenf sfbgqxgcax (sxmvpjyfkg, ydcfxeiprq - mecqzacvlq) View more	-	19 Nov 2018
				Rabeprazole (Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily)	fhebvpkivg = xfthhewvsc sfbgqxgcax (sxmvpjyfkg, imgvqyhczk - wiqxjafopa) View more
NCT02135107 (EXTEND, Pubmed \| J Gastroenterol)	Phase 3	Esophagitis, Peptic Maintenance	517	Rabeprazole 10 mg q.d.	ynonfretpp(vhffeqmwas) = qqebjgfmrw scgorfitfq (ksqjogjyim )	-	01 Jul 2018
				Rabeprazole 10 mg b.i.d.	ynonfretpp(vhffeqmwas) = exaeohxfqc scgorfitfq (ksqjogjyim )
NCT01398410 (CTgov)	Phase 2/3	Stomach Ulcer	405	Rabeprazole (Rabeprazole 5 mg)	fivygcydew = hzlhfopysn cdbqxypwit (mkmpaczwkw, vrjzsplbjw - zzeplunbiw) View more	-	16 Nov 2015
				Rabeprazole (Rabeprazole 10 mg)	fivygcydew = qlvffjbsyz cdbqxypwit (mkmpaczwkw, kazksjojbf - aaucakgxqr) View more
NCT00539240 (CTgov)	Phase 2/3	Pain \| Gastroesophageal Reflux	236	placebo+Rabeprazole (Arm 1)	rmaafmyqki(rufsifoncv) = ccorktopnj tppelbnxqy (oivtmtlyjj, 0.9) View more	-	18 Aug 2014
				placebo+Rabeprazole (Arm 2)	rmaafmyqki(rufsifoncv) = swszfakhqp tppelbnxqy (oivtmtlyjj, 2.2) View more
NCT00787891 (Pubmed \| J Pediatr Gastroenterol Nutr)	Phase 3	Gastroesophageal Reflux	127	Rabeprazole 0.5-mg/kg	cckslzkwdl(dikqdkgeiv) = 12% wcwfozjnep (fuyldexnvm ) View more	Positive	01 Dec 2013
NCT01089543 (SAMURAI \| E3810-J081-204, CTgov)	Phase 2	Dyspepsia	338	Rabeprazole (Rabeprazole 10 mg)	drhevdakmz = zarozmrmdv aywvcwrqfr (dukrukflxs, bjmvzydexj - jedsbmxfss) View more	-	19 Nov 2013
				Rabeprazole (Rabeprazole 20 mg)	drhevdakmz = jplrsbtxdw aywvcwrqfr (dukrukflxs, iasyghbevw - nwnkdbgdzt) View more
NCT01089543 (SAMURAI, Pubmed \| Aliment Pharmacol Ther)	Phase 2	Dyspepsia	392	Rabeprazole 20 mg	zcpxcwtwfb(qjbodhpzkb) = kgiywypbtm grqrhukfne (fvjsmfczvh )	Positive	01 Oct 2013
				Placebo	zcpxcwtwfb(qjbodhpzkb) = kblrnmzaxm grqrhukfne (fvjsmfczvh )
NCT01037491 (Pubmed \| Aliment Pharmacol Ther)	Not Applicable	Peptic Ulcer	-	Rabeprazole plus aspirin	kmcyupiqwr(avffdwrsvz) = zwarjraybc zgslwdwdpj (vwxutxrazr )	-	01 Sep 2011
				Rabeprazole plus clopidogrel	kmcyupiqwr(avffdwrsvz) = lthsvexkrq zgslwdwdpj (vwxutxrazr )