Delving into the Latest Updates on Rebamipide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

MCT-SR, Pramipide, Proamipide

+ [11]

Target

UBASH3B

Mechanism

UBASH3B inhibitors(ubiquitin associated and SH3 domain containing B inhibitors)

Therapeutic Areas

Digestive System DisordersEye Diseases

Active Indication

GastritisStomach UlcerDry Eye Syndromes

Inactive Indication

Acute gastritisAnkylosing SpondylitisChronic gastritis+ [9]

Originator Organization

Otsuka Pharmaceutical Co., Ltd.

Active Organization

Otsuka Pharmaceutical Co., Ltd.Otsuka Holdings Co., Ltd.

Hokkaido University

+ [2]

Inactive Organization

PT Otsuka IndonesiaKorea Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Development & Commercialization, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (28 Sep 1990),

Stomach Ulcer

Regulation-

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Structure/Sequence

Molecular FormulaC19H15ClN2O4

InChIKeyALLWOAVDORUJLA-UHFFFAOYSA-N

CAS Registry90098-04-7

主要研究目的：研究空腹和餐后状态下单次口服受试制剂瑞巴派特片（规格：0.1g，浙江浙北药业有限公司生产）与参比制剂瑞巴派特片（Mucosta®，规格：0.1g，大塚制药株式会社生产）在健康成年受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评价健康受试者在空腹和餐后状态下，单次口服瑞巴派特片受试制剂和参比制剂后的安全性。

[Translation]

Main research purpose: To study the single oral administration of the test preparation Rebamipide Tablets (specification: 0.1g, produced by Zhejiang Zhebei Pharmaceutical Co., Ltd.) and the reference preparation Rebamipide Tablets (Mucosta®, Specification: 0.1g, produced by Otsuka Pharmaceutical Co., Ltd.) in healthy adult subjects to evaluate the bioequivalence of the two oral preparations in fasting and postprandial states. Secondary study purpose: To evaluate the safety of healthy subjects after a single oral administration of the test preparation and reference preparation of rebamipide tablets in fasting and postprandial states.

Start Date04 Dec 2024

Sponsor / Collaborator

Zhejiang Zhebei Pharmaceutical Co. Ltd.

CTR20242604

/ CompletedNot Applicable

瑞巴派特片采用单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计，分为空腹给药和餐后给药的人体生物等效性研究。

[Translation] Rebamipide tablets were studied in a single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design, divided into a human bioequivalence study with fasting administration and postprandial administration.

本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的瑞巴派特片（100 mg）的药代动力学特征；以大塚製薬株式会社生产的瑞巴派特片（Mucosta®，100 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This trial aims to study the pharmacokinetic characteristics of rebamipide tablets (100 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after a single fasting and postprandial oral administration; The special tablet (Mucosta®, 100 mg) is the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations are compared to evaluate the human bioequivalence of the two preparations.

Start Date14 Aug 2024

Sponsor / Collaborator

Anhui Pioneer Pharmaceutical Co. Ltd.

CTR20240809

/ CompletedNot Applicable

健康受试者单次口服瑞巴派特片的随机、开放、两周期、两序列、双交叉，空腹和高脂餐后给药条件下的人体生物等效性试验。

[Translation] A randomized, open-label, two-period, two-sequence, double-crossover bioequivalence study of a single oral dose of rebamipide tablets in healthy subjects under fasting and high-fat meal administration conditions.

主要目的：以药代动力学参数为终点指标，比较空腹和高脂餐后给药条件下，安徽金太阳生化药业有限公司生产的瑞巴派特片与OTSUKA PHARMACEUTICAL Co.,Ltd.（大塚制薬株式会社）原研的瑞巴派特片在健康成年人群中吸收程度和速度的差异，对两制剂的生物等效性进行评价。次要目的：评价空腹和高脂餐后给药条件下，安徽金太阳生化药业有限公司生产的瑞巴派特片在健康成年人群中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as endpoints, compare rebamipide tablets produced by Anhui Golden Sun Biochemical Pharmaceutical Co., Ltd. and OTSUKA PHARMACEUTICAL Co., Ltd. under fasting and high-fat postprandial administration conditions. The bioequivalence of the two preparations was evaluated based on the differences in the degree and rate of absorption of rebamipide tablets originally developed by Tsuka Seiki Co., Ltd. in healthy adults. Secondary purpose: To evaluate the safety of rebamipide tablets produced by Anhui Golden Sun Biochemical Pharmaceutical Co., Ltd. in healthy adults under fasting and high-fat meal administration conditions.

Start Date13 Mar 2024

Sponsor / Collaborator

Anhui Golden Sun Biochemical Pharmaceutical Co. Ltd.

100 Clinical Results associated with Rebamipide

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100 Translational Medicine associated with Rebamipide

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100 Patents (Medical) associated with Rebamipide

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691

Literatures (Medical) associated with Rebamipide

01 Jan 2025·European Journal of Pharmaceutics and Biopharmaceutics

Preparation and characterization of the ground mixture of rebamipide commercial tablets and Hydroxypropyl Cellulose-SSL by ball-milling: Application to the dispersoid of mouthwash suspension

Article

Author: Mizobuchi, Senri ; Hirose, Kaoru ; Ishii, Naoko ; Hanawa, Takehisa ; Kawano, Yayoi

In the present study, to prepare dispersoids with high dispersion stability that can be used as mouthwash, ground mixtures of commercial rebamipide (RB) tablets and hydroxypropyl cellulose (HPC-SSL) samples were prepared by dry milling. The physicochemical properties of the ground mixture of HPC-SSL and the powder obtained from the preliminary ground RB tablets were then compared. The dispersoids' physicochemical properties, dispersion stability, retention, and diffusiveness to the mucosal surfaces were evaluated in vitro. By co-grinding with HPC-SSL, RB transformed into fine particles around 303.6 - 361.5 nm that tended to prevent particle agglomeration in solution over time. The sample microparticles formed with HPC-SSL also avoided agglomeration on the mucosal surface for 24 h, improving oral retention. Furthermore, the ground mixture of HPC-SSL and the powder obtained from the preliminary ground RB tablets dispersed and permeated the mucus gel layer on the mucosal surface (24.2 %) but not the mucosal cells, indicating that RB remained on the mucosal surface. These results suggest that ground mixtures of commercial rebamipide (RB) tablets and hydroxypropyl cellulose (HPC-SSL) samples can be applied as a powdered suspension preparation because they showed high dispersion stability and oral mucosal retention.

01 Jan 2025·Early Intervention in Psychiatry

Psychometric properties of the Spanish version of the measure of insight into cognition‐self‐report in psychosis‐risk and non‐clinical Mexican young adults

Article

Author: Flores, Yvonne ; Domínguez, Tecelli ; Fresán, Ana ; Sheinbaum, Tamara ; Medalia, Alice ; Nieto, Lourdes ; Robles, Rebeca

AbstractAimCognitive disturbances typically precede the onset of overt psychotic symptoms and represent a neurobiological marker for psychosis risk that is also associated with poor functional outcomes. The Measure of Insight into Cognition‐Self Report (MIC‐SR) is a widely used 12‐item questionnaire that assesses the perceived frequency of cognitive impairment in the domains of executing functioning, attention, and memory. However, the MIC‐SR is not available in Spanish, one of the most widely spoken languages worldwide. The present study aimed to provide a Spanish version of the MIC‐SR and examine its psychometric properties in psychosis‐risk and non‐clinical Mexican young adults.MethodsThe sample comprised 621 participants who completed a battery of self‐report measures via an online survey. Of the participants, 478 were non‐clinical, and 143 met the screening criteria for a clinical high‐risk for psychosis (CHR‐positive).ResultsConfirmatory Factor Analyses supported a one‐factor model, consistent with the findings for the original MIC‐SR. The results showed adequate fit indices for the general model and the independent models for both groups, with high Cronbach's alpha coefficients. Furthermore, the CHR‐positive group showed more frequent subjective cognitive problems on each of the 12 items, higher total scores, and higher average frequency than the non‐clinical group.ConclusionTo our knowledge, this is the first translation of the MIC‐SR into Spanish. Using the MIC‐SR at the CHR stage may contribute to our understanding of cognitive processes associated with the onset of a psychotic disorder and provide valuable information in the context of detection and early intervention efforts.

01 Dec 2024·Journal of Ocular Pharmacology and Therapeutics

Effects of Rebamipide for Dry Eye on Optical Quality and Efficacy: A Systematic Review and Meta-Analysis

Review

Author: Ling, Xin-Ru ; Chang, Jing-Yao ; Yan, Yu-Ling ; Xue, Chun-Yan

Purpose: To evaluate the effects of rebamipide ophthalmic suspension on optical quality and efficacy of patients with dry eye under different conditions. Methods: A comprehensive search across five databases (PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure, and Wan Fang) was conducted for studies published through May 13, 2024, focusing on rebamipide for dry eye treatment. Results: A total of 11 studies including 334 patients with dry eye were included. Tear breakup time (TBUT) values of patients with dry eye increased significantly after 2 weeks (standardized mean difference [SMD] =1.07, 95% confidence interval [CI] = [0.05, 2.09]), 4 weeks (SMD = 1.26, 95% CI = [0.77, 1.75]), and 12 weeks (SMD = 1.04, 95% CI = [0.37, 1.71]) of rebamipide treatment. Subgroup analysis revealed that patients with dry eye wearing soft contact lens (SCL) exhibited higher TBUT values after 4 weeks of rebamipide treatment compared with those who received rebamipide alone. In addition, rebamipide significantly improved fluorescein staining score of patients with dry eye after 4 weeks of treatment (SMD = -0.34, 95% CI = [-0.63, -0.06]). However, 4 weeks of rebamipide treatment showed no significant effect on Schirmer I test values (SMD = -0.04, 95%, CI = [-0.43, 0.35]) and higher-order aberrations (SMD = -0.73, 95% CI = [-1.77, 0.30]). Conclusions: These results indicate a significant improvement in the efficacy of rebamipide treatment for patients with dry eye, particularly for those wearing SCL. The effect of rebamipide on visual quality was found to correlate with the underlying dry eye status.

100 Deals associated with Rebamipide

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External Link

KEGG	Wiki	ATC	Drug Bank
D01121	Rebamipide	A02BX14	DB11656

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastritis	JP	Otsuka Holdings Co., Ltd.	01 Jun 1994
Stomach Ulcer	JP	Otsuka Holdings Co., Ltd.	28 Sep 1990

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	NDA/BLA	KR	SAMIL PHARMACEUTICAL Co., Ltd.	-
Acute gastritis	Phase 3	KR	Korea Otsuka Pharmaceutical Co., Ltd.	30 Dec 2019
Ankylosing Spondylitis	Phase 3	KR	Korea Otsuka Pharmaceutical Co., Ltd.	01 Dec 2007
Osteoarthritis	Phase 3	KR	Korea Otsuka Pharmaceutical Co., Ltd.	01 Dec 2007
Rheumatoid Arthritis	Phase 3	KR	Korea Otsuka Pharmaceutical Co., Ltd.	01 Dec 2007
Toxicity	Phase 3	KR	Korea Otsuka Pharmaceutical Co., Ltd.	01 Dec 2007
Chronic gastritis	Phase 3	ID	PT Otsuka Indonesia	01 Oct 2007
Dyspepsia	Phase 3	ID	PT Otsuka Indonesia	01 Oct 2007
Sjogren's Syndrome	Phase 3	JP	Otsuka Pharmaceutical Co., Ltd.	15 Apr 2005
Kerato conjunctivitis sicca	Phase 3	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 May 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2024	Not Applicable	Post Acute COVID 19 Syndrome CRP	62	Rebamipide 100 mg + Omeprazole 20 mg	osaozyemrh(qpaiqajruw) = dfonvqpvhu coxeziorkd (pghvgucddk, [1.85 - 2.62])	Positive	23 Feb 2024
				Omeprazole 20 mg	osaozyemrh(qpaiqajruw) = wdreiamswg coxeziorkd (pghvgucddk, [2.68 - 3.9])
NCT00463151 (CTgov)	Phase 2	Colitis, Ulcerative	124	Rebamipide (Rebamipide 60 mg)	wgpazgspju(yerdqigezp) = pzvrxrmima ajjfhmtohz (obznyjxtzf, rmzvnycnwm - aimtkxcbde) View more	-	20 Jul 2021
				Rebamipide (Rebamipide 150 mg)	wgpazgspju(yerdqigezp) = cbuuzjfoje ajjfhmtohz (obznyjxtzf, pkmzgwcetw - svnveblpig) View more
NCT01471093 (CTgov)	Phase 1	Dry Eye Syndromes	100	OPC-12759 (OPC-12759 Solution With Nasal Root Pressed/Not Pressed)	yiaegufogn(jelvhzjzqr) = aomuvsgokq iyvlpcednu (ljvvlnenip, reinybvylr - uqijwhfjgp) View more	-	29 Jun 2021
				OPC-12759 (OPC-12759 Suspension With Nasal Root Pressed/Not Pressed)	yiaegufogn(jelvhzjzqr) = snkafvszma iyvlpcednu (ljvvlnenip, nyuvxvzfqz - sujayynocj) View more
NCT01660256 (CTgov)	Phase 3	Dry Eye Syndromes	209	Placebo	ergevbjoeo(qmvnbhmqjl) = fafxbhsdng hbubskpupo (ojjniiukwd, kvvlxjpsoz - yrrttffegl) View more	-	05 May 2021
NCT02085460 (CTgov)	Phase 2	radiation oral mucositis \| Head and Neck Neoplasms	94	2% Rebamipide liquid (2% Rebamipide Liquid)	wuexyuhahd(pqazomgsbd) = umeigmxkhn udxvavlrdy (vlnpemrnnw, vpcewqfuxo - somwlvxaix) View more	-	06 Apr 2021
				4% Rebamipide liquid (4% Rebamipide Liquid)	wuexyuhahd(pqazomgsbd) = rehiipzoul udxvavlrdy (vlnpemrnnw, ocvlaxkpmv - rzymdbmncr) View more
UEGW2018	Not Applicable	Esophagitis	-	PPI+rebamipide	(zfbhjrobxu) = pmxrwcfogp dqwvtwalzo (ufjtufbbwi ) View more	-	01 Oct 2018
				PPI	(zfbhjrobxu) = higktqkhgj dqwvtwalzo (ufjtufbbwi ) View more
UEGW2017	Not Applicable	Gastroesophageal Reflux Adjuvant IL-8 \| PAF	109	Lansoprazole	umbkzfvvrw(qpkfinlcex) = lxrneiosyp zfzavfaemu (rufdyrrcaj )	Negative	01 Oct 2017
				Lansoprazole+Rebamipide	umbkzfvvrw(qpkfinlcex) = gfqwluulqt zfzavfaemu (rufdyrrcaj )
NCT01493180 (CTgov)	Phase 2	Corneal epithelial defect	102	OPC-12759 ophthalmic suspension (OPC-12759 Ophthalmic Suspension)	hztywanibp(dzqzkpbfxp) = uwodapkzsa awaccayddw (xlohcptlib, cdadfquphu - vmjtcdtuoq) View more	-	03 Mar 2014
				Sodium hyaluronate ophthalmic solution (Sodium Hyaluronate Ophthalmic Solution)	hztywanibp(dzqzkpbfxp) = nszxcvjejo awaccayddw (xlohcptlib, reybxztrrf - movgcbenqj) View more
NCT00234078 (CTgov)	Phase 2	Dry Eye Syndromes	290	0.5% OPC-12759 (0.5% OPC-12759)	rjuryqvwge(oxlwgwqnoy) = wonyfibucq olcloggxvr (rcmflcpcze, wtxdttkvcp - gaobwzggkh) View more	-	28 Feb 2014
				1% OPC-12759 (1% OPC-12759)	rjuryqvwge(oxlwgwqnoy) = nveidpwigm olcloggxvr (rcmflcpcze, cxqhfsebgg - dqrhutakpv) View more
NCT00818324 (CTgov)	Phase 3	Dry Eye Syndromes	154	rebamipide	yyewopthcm(lpxhpzlqlp) = ndhmtevsdw rwvdxtylyu (wjuqsetksq, zpttmkpxtd - mtwpwjdsax) View more	-	26 Feb 2014