Sarpogrelate

Symptoms such as intermittent claudication and rest pain caused by peripheral arterial disease seriously affect the quality of life of patients, and antiplatelet therapy is one of the core intervention regimens for this type of disease. Sarpogrelate is a selective serotonin 2A (5-HT2A) receptor antagonist. By specifically blocking the 5-HT2A receptors on platelets and vascular smooth muscle, it can not only inhibit serotonin-mediated platelet aggregation, but also antagonize vasoconstriction and improve peripheral circulation, with a lower risk of bleeding compared with traditional antiplatelet drugs. It is mainly used clinically to improve ischemic symptoms such as ulcer, pain and cold sensation caused by chronic arterial occlusive disease, and is one of the preferred therapeutic drugs for patients with peripheral arterial disease combined with diabetes.

The global market size of sarpogrelate maintains a steady growth trend. In 2023, the global market size was approximately USD 320 million, with a compound annual growth rate of around 4.8%. The core growth drivers come from the rising prevalence of peripheral arterial disease and the increasing demand for the management of diabetes-related vascular complications. In terms of the Chinese market, the terminal sales in public hospitals in 2023 were approximately RMB 210 million, and the penetration rate in primary medical institutions is increasing year by year. At present, the original research product still occupies the dominant share in the domestic market, and 3 enterprises have passed the generic drug consistency evaluation. With the expansion of the coverage of centralized procurement, the market share of generic drugs is expected to increase to more than 40% in 2026.

The original research enterprise of sarpogrelate is Mitsubishi Tanabe Pharma of Japan, and the original brand name is "Anplag". Its core compound patent expired in 2013 in major markets such as Japan and the United States, and the expiration date of the compound patent in China is 2012. The main dosage form approved for the original research product is tablet with a specification of 100mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and also listed in the FDA Reference Preparation Catalogue. In terms of domestic API registration, there are currently 7 sarpogrelate API registration entries on the CDE platform, among which 5 have been publicized with A status; on the preparation level, in addition to the original research product, 4 domestic generic drugs have been approved for marketing, all of which have passed the consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sarpogrelate API, which can cover all research dimensions such as synthetic process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet various testing needs in the stages of API R&D, quality research and registration application.