盐酸吲地司琼(Indisetron Hydrochloride) - 药物靶点：5-HT3 receptor_在研适应症：恶心和呕吐，恶心，呕吐_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Indisetron、Indisetron Dihydrochloride、Indisetron hydrochloride (JAN)

+ [3]

靶点

5-HT3 receptor

作用机制

5-HT3 receptor拮抗剂(5-羟色胺受体3拮抗剂)

治疗领域

其他疾病

在研适应症

恶心和呕吐恶心呕吐

非在研适应症-

原研机构

Nisshin Flour Milling Co Ltd

在研机构

北京嘉林药业股份有限公司

KYORIN Pharmaceutical Co., Ltd.Nisshin Kyorin Pharmaceutical Co. Ltd.

非在研机构

SK Chemicals Co. Ltd.

最高研发阶段批准上市

首次获批日期

日本 (2004-01-29),

恶心呕吐

最高研发阶段(中国)临床2期

特殊审评-

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结构/序列

分子式C17H23N5O

InChIKeyMHNNVDILNTUWNS-XYYAHUGASA-N

CAS号141549-75-9

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关联

4

项与盐酸吲地司琼相关的临床试验

CTR20170613

/ Recruiting临床2期

盐酸吲地司琼片预防化疗所致恶心和呕吐的有效性和安全性的随机、双盲双模拟、自身交叉对照、多中心临床试验

评价盐酸吲地司琼片预防化疗所致恶心和呕吐的有效性和安全性

开始日期2017-03-03

申办/合作机构

北京嘉林药业股份有限公司

JPRN-UMIN000010162

/ Completed临床2期IIT

Randomized pilot study evaluating indisetron tablets for the prevention of acute-onset diarrhea, nausea and vomiting with IRIS or FOLFIRI for metastatic colorectal cancer patients: HGCSG 0704 - Randomized study to explore indisetron for the prevention of acute-onset diarrhea, nausea, vomiting with IRIS/FOLFIRI: HGCSG 0704

开始日期2008-04-01

申办/合作机构

Hokkaido University

JPRN-UMIN000017576

/ Completed临床2期IIT

Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703 - Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703

开始日期2008-01-09

申办/合作机构-

100 项与盐酸吲地司琼相关的临床结果

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100 项与盐酸吲地司琼相关的转化医学

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100 项与盐酸吲地司琼相关的专利（医药）

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9

项与盐酸吲地司琼相关的文献（医药）

2012-01-01·Chemotherapy4区 · 医学

Optimal Dose Period for Indisetron Tablets for Preventing Chemotherapy-Induced Nausea and Vomiting with Modified FOLFOX6: A Randomized Pilot Study

4区 · 医学

Article

作者: Nakatsumi, Hiroshi ; Muto, Shuichi ; Komatsu, Yoshito ; Uebayashi, Minoru ; Yuki, Satoshi ; Sogabe, Susumu ; Kudo, Mineo ; Oba, Koji ; Asaka, Masahiro ; Tateyama, Miki ; Kato, Kanji ; Meguro, Takashi ; Miyagishima, Takuto

Background: Indisetron is a serotonin (5-hydroxytryptamine type 3) receptor antagonist that also antagonizes 5-hydroxytryptamine type 4 receptors. We designed a pilot study in order to explore the optimal dosing period for indisetron during modified FOLFOX6 (mFOLFOX6). Patients and Methods: Forty-two chemotherapy-naive patients with advanced colorectal cancer scheduled to receive mFOLFOX6 were randomly assigned to either a 1- or 3-day indisetron regimen arm. The primary endpoint was complete protection from vomiting. Results: Proportions of patients with complete protection from vomiting were 85.7% [95% confidence interval (CI) 63.7–97.0] with the 3-day regimen and 81.0% (95% CI 58.1–94.6) with the 1-day regimen. Proportions of patients with complete protection from nausea were 47.6% in each arm (95% CI 25.7–70.2). No rescue therapy rates were 66.7% (95% CI 43.0–85.4) versus 57.1% (95% CI 34.0–78.2). No severe adverse events were observed in either arm. Conclusion: Both 1- and 3-day indisetron regimens were feasible for preventing nausea and vomiting induced by mFOLFOX6.

2009-12-01·International Journal of Clinical Oncology

Receptor occupancy theory-based analysis of interindividual differences in antiemetic effects of 5-HT3 receptor antagonists

Article

作者: Ozeki, Takeshi ; Ayuhara, Hideaki ; Yokoyama, Haruko ; Okuyama, Kiyoshi ; Yamada, Yasuhiko ; Yoshimoto, Koichi ; Takayanagi, Risa

BACKGROUNDThe aim of this study was to estimate interindividual differences in the antiemetic effects of 5-HT(3) receptor antagonists by evaluating the influence of pharmacokinetics on 5-HT(3) receptor occupancies, based on receptor occupancy theory.METHODSWe analyzed interindividual differences of 5-HT(3) receptor occupancies and antiemetic effects after the oral and/or intravenous administration of standard doses of the following 5-HT(3) receptor antagonists: azasetron, granisetron, indisetron, ondansetron, ramosetron, and tropisetron.RESULTSThe interindividual difference between maximum and minimum 5-HT(3) receptor occupancies after oral administration ranged from 0.6% to 64.0%, and that difference after intravenous administration ranged from 0.6% to 29.6%. Following oral administration, the interindividual difference between maximum and minimum complete vomiting inhibition rates ranged from 0.2% to 16.1%. After intravenous administration, that difference ranged from 0.8% to 52.5%.CONCLUSIONInterindividual differences in the clinical effects of 5-HT(3) receptor antagonists could be evaluated based on receptor occupancy theory, and the differences varied among drugs. Drug selection considering these individual variations might be useful for the patients who experienced vomiting associated with chemotherapy.

2009-09-01·Gan to kagaku ryoho. Cancer & chemotherapy

[The efficacy of indisetron hydrochloride for the management of chemotherapy-induced nausea and vomiting for lung cancer].

Article

作者: Nagai, Atsushi ; Isono, Kazuo ; Izumo, Takehiro ; Tamaoki, Jun ; Takeda, Naoko ; Kanemura, Toshinori ; Iritani, Eiichi

We set out to determine the efficacy of indisetron hydrochloride for the management of chemotherapy-induced nausea and vomiting including carboplatin for lung cancer. Indisetron hydrochloride was given orally to 32 patients (indisetron group), and intravenous 5-HT3 receptor antagonists were given to 24 patients (control group). The number of patients with nausea or vomiting occurring within 24 hours and 24 to 72 hours after chemotherapy was measured. The complete inhibition of the vomiting within 24 hours after chemotherapy was 100% in the indisetron group and 95.8% in the control group. Twenty-four to 72 hours after chemotherapy, the complete inhibition of vomiting rate was 97.1% and 95.8%, respectively. In addition, the complete inhibition of nausea rate within 24 hours after chemotherapy was 87.5% in the indisetron group and that was 95.8% in the control group. The complete inhibition of nausea rate 24 to 72 hours after chemotherapy was 56.3% and 70.8%, respectively. No serious adverse events were observed. The comparison of the efficacy between the indisetron group and control groups did not reach statistical significance (p> 0.05). These findings suggest that prophylactic administration of indisetron hydrochloride is useful for the inhibition of acute and delayed nausea and vomiting caused by chemotherapy in lung cancer patients.

100 项与盐酸吲地司琼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02632	盐酸吲地司琼	A04A	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
恶心和呕吐	日本	-	2004-09-20
恶心	日本	-	2004-01-29
呕吐	日本	-	2004-01-29

未上市

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适应症	最高研发状态	国家/地区	公司	日期
恶心	临床2期	中国	北京嘉林药业股份有限公司	2017-03-03
呕吐	临床2期	中国	北京嘉林药业股份有限公司	2017-03-03

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


HGCSG0703 (ASCO_GI2011)	N/A	化疗引起的恶心和呕吐一线	45	3-day regimen of indisetron	夢簾選齋繭艱餘遞餘鹹(鑰製範廠願糧壓獵鹹糧) = 餘夢衊積襯襯廠積願壓鹹壓選醖膚構窪壓糧淵 (繭膚選築醖鹽範顧鏇鹹 )	-	2011-02-01
				single dose of indisetron	夢簾選齋繭艱餘遞餘鹹(鑰製範廠願糧壓獵鹹糧) = 窪鬱顧鬱蓋壓衊餘憲網鹹壓選醖膚構窪壓糧淵 (繭膚選築醖鹽範顧鏇鹹 )