Delving into the Latest Updates on Indisetron Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Indisetron, Indisetron Dihydrochloride, Indisetron hydrochloride (JAN)

+ [3]

Target

5-HT3 receptor

Mechanism

5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists)

Therapeutic Areas

Other Diseases

Active Indication

Nausea and vomitingNauseaVomiting

Inactive Indication-

Originator Organization

Nisshin Flour Milling Co Ltd

Active Organization

Beijing Jialin Pharmaceutical Co., Ltd.

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

Inactive Organization

SK Chemicals Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

JP (29 Jan 2004),

NauseaVomiting

Regulation-

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Structure

Molecular FormulaC17H23N5O

InChIKeyMHNNVDILNTUWNS-XYYAHUGASA-N

CAS Registry141549-75-9

View All Structures (2)

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

Start Date01 Apr 2008

Sponsor / Collaborator

Hokkaido University

JPRN-UMIN000017576 / CompletedPhase 2IIT

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

Start Date09 Jan 2008

Sponsor / Collaborator-

100 Clinical Results associated with Indisetron Hydrochloride

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100 Translational Medicine associated with Indisetron Hydrochloride

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100 Patents (Medical) associated with Indisetron Hydrochloride

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8

Literatures (Medical) associated with Indisetron Hydrochloride

01 Jan 2012·ChemotherapyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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.

01 Sep 2009·Gan to kagaku ryoho. Cancer & chemotherapy

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

Article

Author: 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.

01 Jul 2008·Gan to kagaku ryoho. Cancer & chemotherapy

[The efficacy and safety of indisetron hydrochloride for the management of nausea/vomiting caused by chemotherapy for gynecologic cancer].

Article

Author: Hachisuga, Toru ; Ushijima, Kimio ; Kawarabayashi, Tatsuhiko ; Masuzaki, Hideaki ; Kobayashi, Hiroaki ; Kotera, Kohei ; Emoto, Makoto ; Wake, Norio ; Toki, Naoyuki ; Kamura, Toshiharu

This clinical trial was designed to evaluate the efficacy and safety of indisetron hydrochloride an oral 5-HT3 receptor antagonist, for the management of nausea/vomiting caused by chemotherapy for gynecologic cancer with paclitaxel/ carboplatin or docetaxel/carboplatin. Indisetron hydrochloride(8 mg)was administered orally to 46 gynecologic cancer patients at 0.5 hours before administration of the above chemotherapy agents. Number of patients who showed nausea or vomiting for 24 hours was counted. The complete vomiting inhibition rate at 24 hours after chemotherapy was 89.1%(41/46), and nausea inhibition rate was 71.7%(33/46). No serious adverse events were observed. These findings indicate that prophylactic administration of indisetron hydrochloride is safe and useful for inhibition of nausea/vomiting caused by cancer chemotherapy.

100 Deals associated with Indisetron Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D02632	Indisetron Hydrochloride	A04A	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Nausea and vomiting	JP	-	20 Sep 2004
Nausea	JP	-	29 Jan 2004
Vomiting	JP	-	29 Jan 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nausea	Phase 2	CN	Beijing Jialin Pharmaceutical Co., Ltd.	03 Mar 2017
Vomiting	Phase 2	CN	Beijing Jialin Pharmaceutical Co., Ltd.	03 Mar 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


HGCSG0703 (ASCO_GI2011)	Not Applicable	Chemotherapy-induced nausea and vomiting First line	45	3-day regimen of indisetron	srqcqclqni(wzdufimftd) = skmyfzvzaa uleoeafbon (lqiyyztwhq )	-	01 Feb 2011
				single dose of indisetron	srqcqclqni(wzdufimftd) = hqdacyjnad uleoeafbon (lqiyyztwhq )