Indisetron

Chemotherapy-induced nausea and vomiting is one of the most common adverse reactions in tumor treatment. Nearly 30% of patients delay or even discontinue anti-tumor treatment due to intolerance to this side effect. The advent of 5-HT₃ receptor antagonists has greatly improved this clinical dilemma. Indisetron is a second-generation highly selective 5-HT₃ receptor antagonist. By competitively blocking 5-HT₃ receptors in peripheral vagus nerve endings and the central chemoreceptor trigger zone, it inhibits the vomiting reflex triggered by 5-HT released from intestinal chromaffin cells stimulated by chemotherapeutic drugs. Its antiemetic effect lasts for more than 24 hours, and it does not cause extrapyramidal reactions commonly seen with first-generation drugs. It is suitable for the prevention and treatment of acute nausea and vomiting caused by moderately to highly emetogenic chemotherapeutic drugs such as cisplatin and doxorubicin, and is a common medication option for clinical tumor supportive care.

The global market size of 5-HT₃ receptor antagonists is growing steadily. In 2023, the overall size exceeded 2.8 billion US dollars, with second-generation products accounting for more than 65%. Due to its strong antiemetic efficacy and low incidence of adverse reactions, the penetration rate of indisetron in the Asian market is increasing year by year. At present, there are fewer than 10 generic drug application enterprises for this variety in China, the market competition pattern is relatively loose, and it has not been included in the scope of national centralized volume-based procurement. The market space of related active pharmaceutical ingredients and preparations still has expansion potential. If there is no verifiable authoritative data, relevant market information shall be subject to the official release.

The original research enterprise of indisetron is Japan Tobacco Inc., and the original research trade name is "Serotone". Its compound patent in Japan expired in 2007, and all core patents in China have expired. The approved dosage form of the original research product is injection, with a specification of 2ml:5mg. The original research injection has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. As of the retrieval time point, there is no indisetron active pharmaceutical ingredient registered and approved by the Center for Drug Evaluation (CDE) in China, nor is there any domestic indisetron preparation approved for marketing. Only the original research imported preparation can be used in domestic clinical practice. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of indisetron, CATO provides a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in drug declaration, quality research and daily production testing.