Tropisetron

Overview

Tropisetron is an indole derivative with antiemetic activity. As a selective serotonin receptor antagonist, tropisetron competitively blocks the action of serotonin at 5HT3 receptors, resulting in suppression of chemotherapy- and radiotherapy-induced nausea and vomiting. Tropisetron appears to be well tolerated with the most frequently reported adverse effect being headache. Extrapyramidal side effects are rare upon using tropisetron.

Indication

For the prevention of nausea and vomiting induced by cytotoxic therapy and postoperative.

Associated Conditions

Chemotherapy-Induced Nausea and Vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer	2022/10/03	NCT05564286	Phase 3	Completed	Shantou University Medical College
Efficacy of Three Antiemetics in Preventing Nausea and Vomiting	2022/09/09	NCT05533281	Phase 4	Completed	The Second Affiliated Hospital of Chongqing Medical University
A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery	2019/12/11	NCT04195204	Phase 4	UNKNOWN	Beijing Chao Yang Hospital
The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium	2019/07/22	NCT04027751	Phase 4	UNKNOWN	Beijing Chao Yang Hospital
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis	2015/12/09	NCT02625181	Not Applicable	Completed	Vanderbilt University
A Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation	2015/10/15	NCT02576327	Phase 4	UNKNOWN	Jun Zhu
Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting	2015/06/23	NCT02478047	Not Applicable	UNKNOWN	Tianjin University of Traditional Chinese Medicine
Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting	2014/03/26	NCT02096835	Not Applicable	Completed	Huashan Hospital
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE	2013/07/10	NCT01895010	Phase 2	UNKNOWN	Fudan University
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)	2012/07/10	NCT01636947	Phase 4	Completed	Merck Sharp & Dohme LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TROPISETRON-AFT tropisetron (as hydrochloride) 5 mg/5 mL solution for injection ampoule	189944	AFT Pharmaceuticals Pty Ltd	Medicine	A	11/16/2012
TROPISETRON MYX tropisetron (as hydrochloride) 2 mg/2 mL solution for injection or infusion ampoules	246633	Juno Pharmaceuticals Pty Ltd	Medicine	A	4/28/2016
TROPISETRON-AFT tropisetron (as hydrochloride) 2 mg/2 mL solution for injection ampoule	189943	AFT Pharmaceuticals Pty Ltd	Medicine	A	11/16/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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