Dolasetron

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common adverse reactions in the treatment process of tumor patients, which seriously affects the treatment compliance and quality of life of patients. As a highly selective 5-hydroxytryptamine 3 (5-HT₃) receptor antagonist, dolasetron blocks 5-HT₃ receptors in peripheral and central neurons to inhibit the signal transduction of the vomiting reflex, and is currently one of the mainstream clinical drugs for the prevention and treatment of postoperative nausea and vomiting and chemotherapy-related nausea and vomiting. It is suitable for adult tumor patients receiving chemotherapy and surgical populations who need to prevent postoperative nausea and vomiting, with long-lasting antiemetic effect, low incidence of extrapyramidal adverse reactions and good clinical tolerance.

At present, the global antiemetic market size has exceeded 4 billion US dollars, of which 5-HT₃ receptor antagonists account for about 35%. With lower risk of cardiotoxicity, dolasetron has maintained a market growth rate of around 7% in recent years, which is higher than the average level of similar products. In the domestic market, the existing dolasetron preparations are mainly generic drugs, which have been included in the National Medical Insurance Catalog (Class B). In 2023, the terminal sales in public medical institutions exceeded 900 million yuan. With the improvement of tumor diagnosis and treatment rate and the popularization of day surgery, its clinical demand still has room for further release.

The original developer of dolasetron is Sanofi, France, with the original brand name "Anzemet". Its compound patent in the United States expired in 2012, and the compound patent in China expired in 2014. The main dosage forms approved for the original product include tablets (50mg, 100mg) and injections (12.5mg/1mL, 100mg/5mL). Both the original injection and tablets have been included in the FDA Reference Listed Drug Catalog, and the above dosage forms are also included in the domestic Reference Listed Drug Catalog. As of now, more than 10 enterprises have obtained A status registration for dolasetron APIs on the CDE API Registration Platform, and multiple domestic enterprises have obtained marketing approval for dolasetron injections and tablets. (Data as of July 2024, please refer to the official website of CDE for the latest information)

CATO provides a full range of dolasetron impurity reference standards, most of which are available from stock. Stock orders paid before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation.