预约演示
更新于：2025-05-16
Itopride Hydrochloride
盐酸伊托必利
更新于：2025-05-16
概要
基本信息
药物类型 小分子化药 |
别名 Itax、Itopride、Itopride Hydrochloridc + [19] |
作用方式 抑制剂、拮抗剂 |
作用机制 AChE抑制剂(乙酰胆碱酯酶抑制剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂) |
非在研适应症 |
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- |
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结构/序列
分子式C20H27ClN2O4 |
InChIKeyZTOUXLLIPWWHSR-UHFFFAOYSA-N |
CAS号122892-31-3 |
关联
38
项与 盐酸伊托必利 相关的临床试验TCTR20241012004
A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Generic Itopride Hydrochloride 50 mg Film Coated Tablets and Reference Product (Ganaton) in Healthy Thai Subjects under Fasting Conditions
CTR20241978
盐酸伊托必利片在健康受试者中单剂量、随机、开放、空腹两周期/餐后四周期、两序列、交叉设计的生物等效性试验
NCT06217393
Randomized Multicentre Open-label Study to Investigate the Non-inferiority of Itopride Hydrochloride 150mg Once Daily Versus Itopride Hydrochloride 50 mg Thrice Daily in Subjects With Functional (Non-ulcer) Dyspepsia or Chronic Gastritis
100 项与 盐酸伊托必利 相关的临床结果
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100 项与 盐酸伊托必利 相关的转化医学
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100 项与 盐酸伊托必利 相关的专利（医药）
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424
项与 盐酸伊托必利 相关的文献（医药）2025-05-05CURRENT PHARMACEUTICAL DESIGN
The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy
Article
作者: Majeed, Muhammad Irfan ; Saif, Ayesha ; Fatima, Rida ; Akbar, Haseeb ; Ijaz, Tehseen ; Nawaz, Haq ; Alshammari, Abdulrahman ; Ehsan, Maida ; Ali, Arslan ; Albekairi, Norah A. ; Naheed, Iqra ; 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.
Method::
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.
2025-01-02Expert Opinion On Drug Safety
Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database
Article
作者: Li, Jiayu ; Zhou, Ying ; Jia, Boying ; Zhou, Shuang ; Wan, Liyan ; Cui, Yimin
BACKGROUND:
Drug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).
RESEARCH DESIGN AND METHODS:
Delirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.
RESULTS:
Of the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.
CONCLUSION:
Drug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.
2025-01-01Therapeutic Advances in Gastroenterology
Itopride in functional dyspepsia: open-label, 1-year treatment follow-up of two multicenter, randomized, double-blind, placebo-controlled trials
Article
作者: Tack, Jan ; Broeders, Bert ; Talley, Nicholas J.
Background::
Functional dyspepsia (FD) is common but few efficacious therapies exist. Itopride, a prokinetic, acts via dopamine D2 receptor antagonism and acetylcholinesterase inhibition, and is now approved in Japan, Mexico, and Europe for FD. However, long-term efficacy and safety data have not been published.
Objective::
To evaluate the long-term safety and potential effectiveness of itopride.
Design::
A long-term open-label drug effectiveness study.
Methods::
Males and females, 18–65 years, with FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. After the double-blind treatment phase, patients were treated in an open-label extension phase.
Results::
A total of 798 patients were included in these two open-label trials and received at least one dose of study medication; 551 patients (69.0%) completed 6 months of treatment, and 294 patients (36.8%) completed a 12-month period. Response rates based on the global physician assessment were 61.7%, 64.8%, 69.0 %, 69.1%, 70.1%, 73.1%, and 77.9% at weeks 8, 16, 24, 32, 40, 48, and 52, respectively. Compliance was above 95%. The safety and tolerability profiles were as expected, with the majority of adverse events being gastrointestinal. Prolactin elevations occurred in 3% of the cases but were not clinically significant. No ECG changes were identified.
Conclusion::
In this population, itopride, given for up to 12 months, was safe, and up to two-thirds appeared to maintain symptom benefit.
Trial registration::
NCT00110968 and NCT00112203.
100 项与 盐酸伊托必利 相关的药物交易
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研发状态
批准上市
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| 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
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| 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 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | - | 繭簾膚鏇艱獵齋鑰齋醖(蓋繭淵觸築鬱鹹襯襯蓋) = 築壓艱衊製鬱製網窪衊 壓鏇築淵壓糧齋鏇簾襯 (選醖鏇築願鏇顧範衊製, 25) | - | 2018-10-01 | ||
繭簾膚鏇艱獵齋鑰齋醖(蓋繭淵觸築鬱鹹襯襯蓋) = 鑰鹽簾餘壓衊衊餘膚糧 壓鏇築淵壓糧齋鏇簾襯 (選醖鏇築願鏇顧範衊製, 32) | |||||||
N/A | - | 艱製選鑰窪艱蓋鏇鹽蓋(餘築築鹽網憲壓憲蓋獵) = 廠窪艱觸願鬱襯窪簾構 鑰鹹齋糧壓衊築衊艱憲 (選襯憲蓋鏇遞遞簾繭襯 ) 更多 | - | 2005-06-01 | |||
Placebo | 艱製選鑰窪艱蓋鏇鹽蓋(餘築築鹽網憲壓憲蓋獵) = 齋鹹觸獵網壓構觸繭齋 鑰鹹齋糧壓衊築衊艱憲 (選襯憲蓋鏇遞遞簾繭襯 ) 更多 |
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