预约演示
更新于：2026-02-27
Itopride Hydrochloride
盐酸伊托必利
更新于：2026-02-27
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1995-06-30), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C20H27ClN2O4 |
InChIKeyZTOUXLLIPWWHSR-UHFFFAOYSA-N |
CAS号122892-31-3 |
关联
47
项与 盐酸伊托必利 相关的临床试验NCT07254715
Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
CTR20254003
评估受试制剂与参比制剂盐酸伊托必利片在空腹/餐后状态下作用于中国健康成年研究参与者的单中心、开放、随机、单剂量、多周期、交叉生物等效性研究
CTR20253535
盐酸伊托必利片人体生物等效性研究
100 项与 盐酸伊托必利 相关的临床结果
登录后查看更多信息
100 项与 盐酸伊托必利 相关的转化医学
登录后查看更多信息
100 项与 盐酸伊托必利 相关的专利（医药）
登录后查看更多信息
255
项与 盐酸伊托必利 相关的文献（医药）2026-02-01Therapeutic Advances in Gastroenterology
Impact of itopride on functional dyspepsia symptom progression: a multicenter noninterventional postregistration study
Article
作者: Kroupa, Radek ; Pavlík, Tomáš ; Bortlík, Martin ; Tack, Jan ; Novotny, Michal ; Dolina, Jiri ; Schol, Jolien ; Forostyak, Serhiy ; Tachecí, Ilja
Background::
Functional dyspepsia (FD) is a prevalent condition characterized by symptoms such as postprandial fullness, early satiety, and epigastric pain, which significantly affect daily activities and quality of life.
Objectives::
This study aimed to assess the effectiveness of itopride hydrochloride, a prokinetic agent, in reducing the severity of these symptoms among patients with FD.
Design::
In this noninterventional, observational, post-authorization, prospective, multicenter study (without placebo or comparator) 339 patients with FD were treated with itopride and followed over a period of 12 weeks. The study clinical protocol ITO-NPS-01-PMCS-2021 was approved by the Ethical Committee of the University Hospital Brno and Faculty of Medicine, Masaryk University, Brno (ORG No: 100022981/LOC No:100031711), and reported to the Czech State Institute of Drug Control (identifier: 2110140000) following local legislation.
Methods::
The patients’ symptoms were quantified at baseline, 3–6 weeks, and 7–12 weeks using the modified “Leuven Postprandial Distress Scale.” Statistical analysis involved the Wilcoxon test, Mann–Whitney test, and Kruskal–Wallis test, focusing on changes in symptom scores and following potential adverse effects (AEs) over time.
Results::
Itopride hydrochloride treatment resulted in a statistically significant median reduction in symptom severity scores from baseline to the first and second follow-up assessments. The scores decreased by 5 points at the first follow-up and by 8 points at the second follow-up across all FD patient subgroups, regardless of age and gender. The study also observed minimal AEs, with only 2% of patients experiencing mild symptoms.
Conclusion::
Itopride appears to be a safe and effective treatment for reducing symptom severity in patients with FD. The findings support the use of itopride in clinical settings, providing evidence of its benefit in managing this challenging condition. This study brings additional clinical knowledge from the eastern European population (Czechs) to data published by the ROME IV foundation with various cohorts of patients with FD and its results further demonstrate the long-term benefits and safety profile of itopride with minimal non-AEs.
2026-02-01NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
Quality by design approach for optimization, in-vitro and in-vivo evaluation of compression-spheronized itopride hydrochloride loaded gastroretentive pellets for the treatment of gastroesophageal reflux disease
Article
作者: Dass, Rameshwar ; Lohan, Sunidhi ; Rani, Pooja ; Choudhary, Neeraj ; Mahmood, Syed ; Bhatia, Meenakshi ; Kumar, Dinesh
Gastroesophageal reflux disease (GERD) is the most common disorder with a significantly high global prevalence. Prokinetic drugs are commonly recommended for the treatment of gastric reflux, in addition to antacids and antisecretory agents. Itopride hydrochloride, a prokinetic agent, acts as a D2 receptor antagonist and an acetylcholinesterase inhibitor, improving GERD symptoms. The objective of this study was to develop a floating-type gastroretentive drug delivery system, which was further evaluated by in vitro and in vivo studies. Itopride hydrochloride-loaded gastroretentive pellets were prepared using pelletization followed by spheronization. The preparation of itopride-loaded gastroretentive pellets was optimized using a central composite experimental design (32), varying the concentrations of ethylcellulose and Eudragit S100 as independent variables, while floating time and percentage of drug release were considered dependent variables.The optimized batch was characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC), and Fourier-transform infrared spectroscopy (FTIR). It was then evaluated for mucoadhesion, in vivo gastric retention, and bioavailability in rabbits. The in vitro drug release from the optimized pellet formulation exhibited approximately 97.84% release over 10 h and maintained buoyancy for up to 9 h. In vivo gastric residence time was observed to be 6 h, with a bioavailability of 52.87 ± 0.15 µg/mL/h. Based on in vitro and in vivo findings, the developed gastroretentive mucoadhesive pellet formulation presents a promising drug delivery system for the treatment of GERD, potentially enhancing drug efficacy through prolonged gastric retention.
2026-01-01CURRENT PHARMACEUTICAL DESIGN
The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy
Article
作者: Saif, Ayesha ; Majeed, Muhammad Irfan ; Fatima, Rida ; Akbar, Haseeb ; Ijaz, Tehseen ; Nawaz, Haq ; Alshammari, Abdulrahman ; Naheed, Iqra ; Ali, Arslan ; Ehsan, Maida ; Albekairi, Norah A. ; Aziz, Aleena
Objective::
This study explores the application of Raman spectroscopy for identifying and quantifying
itopride in solid dosage forms with varying concentrations of active ingredients and excipients. Raman
spectroscopy provides a non-invasive, rapid, and accurate detection method that is ideal for pharmaceutical
analysis.
Methods::
The Raman spectral features of itopride in solid dosage forms were analyzed using Principal Component
Analysis (PCA) and Partial Least Squares Regression Analysis (PLS-RA) as multivariate data analysis
techniques.
Results::
PCA effectively distinguished Raman spectral data of various itopride drug samples. PLS-RA facilitated
quantitative analysis, yielding an R2 value of 0.999%, indicating an excellent explanation of model variability.
The root mean square error of calibration and prediction were 0.23 mg and 3.02 mg, respectively. Furthermore,
PLS-RA accurately determined the active pharmaceutical ingredient concentration in unknown
formulations, with a calculated concentration of 79.66/80 mg (w/w) compared to the actual concentration of
80/140 mg (w/w).
Conclusion::
These findings demonstrated that the concentration of itopride in pharmaceutical samples using
an established Partial Least Squares Regression calibration model can be determined with reliability.
100 项与 盐酸伊托必利 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 胃肠道疾病 | 印度 | 2003-01-20 | |
| 慢性胃炎 | 日本 | 1995-06-30 | |
| 心脏衰竭 | 中国 | - | - |
| 高血压 | 中国 | - | - |
| 恶心 | - | - | - |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 餐后窘迫综合征 | 临床3期 | 亚美尼亚 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 马来西亚 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 菲律宾 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 泰国 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 越南 | 2024-02-28 | |
| 胃灼热 | 临床3期 | 美国 | 2006-10-01 | |
| 肠道疾病 | 临床3期 | 美国 | 2005-11-01 | |
| 腹部膨胀 | 临床3期 | 加拿大 | 2004-07-01 | |
| 消化不良 | 临床3期 | 德国 | 2000-12-01 | |
| 便秘型肠易激综合征 | 临床2期 | 巴基斯坦 | 2008-06-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 798 | 範網網鏇窪積襯構築憲(廠淵鏇鑰鹹遞壓餘製齋) = The majority of adverse events were gastrointestinal. Prolactin elevations occurred in 3% of the cases but were not clinically significant. No ECG changes were identified. 鏇鬱淵醖積餘窪願壓願 (夢獵選糧鹹製遞鬱願觸 ) | 积极 | 2025-01-01 | |||
Placebo | |||||||
临床4期 | 180 | Treatment according to subtype (Epigastric Pain Syndrome) | 顧觸憲鏇遞餘範鏇網齋(簾鏇餘積築鑰遞艱構鹽) = 構顧壓襯憲繭襯餘願範 積積積餘遞夢餘醖餘顧 (顧蓋壓淵獵築艱膚選鏇 ) | 不佳 | 2024-12-02 | ||
Empirical Proton Pump Inhibitor (Esomeprazole) | 顧觸憲鏇遞餘範鏇網齋(簾鏇餘積築鑰遞艱構鹽) = 鏇淵壓膚窪醖遞選網夢 積積積餘遞夢餘醖餘顧 (顧蓋壓淵獵築艱膚選鏇 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用