Tropisetron

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common adverse reactions in tumor patients during radiotherapy and chemotherapy, with an incidence rate of over 70%, which seriously affects the treatment compliance and quality of life of patients. Tropisetron is a highly selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonist. It specifically blocks the excitation of presynaptic 5-HT3 receptors in peripheral neurons, and simultaneously inhibits the signal transmission of the central vagal afferent pathway. Through this dual action, it reduces the trigger of vomiting reflex. It is a first-line drug for clinical prevention and treatment of acute and delayed CINV, and can also be used for the intervention of nausea and vomiting after surgical anesthesia. The applicable population covers tumor patients receiving radiotherapy and chemotherapy, patients needing vomiting prevention during the perioperative period, etc.

The global market size of tropisetron is approximately USD 230 million, with the Chinese market accounting for over 45%, and the compound annual growth rate maintains at around 3.2%. As a variety with lower incidence of adverse reactions among the first-generation 5-HT3 receptor antagonists, its clinical recognition continues to improve. At present, the domestic market is dominated by generic drug supply. After the centralized procurement, the terminal price has dropped by over 60%, the accessibility has been greatly improved, the overall competitive landscape tends to be stable, and the top 3 generic drug enterprises account for nearly 70% of the market share.

The original research enterprise of tropisetron is Novartis, and the original trade name is "Navoban". The core compound patent of it expired globally in 2004. The main dosage forms of the original product are capsules and injections. The specification of capsules is 5mg, and the specification of injections is 5mg/5mL. The original product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and also included in the FDA Reference Preparation Catalogue. As of now, more than 20 enterprises in China have obtained A status for their tropisetron API through CDE registration, and more than 30 preparation varieties have been approved for marketing, covering multiple dosage forms such as injections, capsules, orally disintegrating tablets, etc. (Data as of May 2025, please refer to the official website of CDE for the latest information.)

CATO provides a full set of tropisetron impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the demands of API enterprises for impurity reference standards during R&D, quality research and production processes.