Levosimendan

Acute decompensated heart failure is one of the acute and severe diseases in the cardiovascular field. Traditional positive inotropic drugs tend to increase myocardial oxygen consumption, and long-term use carries the risk of adverse prognosis. The clinical application of levosimendan provides a safer treatment option for such patients. As a new generation of calcium sensitizer class positive inotropic drugs, its mechanism of action is different from that of traditional β-receptor agonists. It can enhance myocardial contractility by binding to cardiac troponin C, and at the same time open ATP-sensitive potassium channels on vascular smooth muscle to dilate peripheral blood vessels, without significantly increasing myocardial oxygen consumption, and can also improve myocardial energy metabolism. At present, it is mainly clinically used for patients with acute decompensated heart failure who have poor response to traditional diuretics and vasodilators and need to enhance myocardial contractility, especially suitable for heart failure populations with concomitant coronary heart disease and myocardial ischemia.

The global market size of levosimendan has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 420 million, with the Chinese market accounting for nearly 35%, and the compound annual growth rate reaching 8.7%. In terms of the competitive landscape, the original research product still accounts for nearly 60% of the global market share. Domestic generic drug companies have been successively approved for marketing. At present, 5 local enterprises have obtained the approval of levosimendan injection through the consistency evaluation of generic drugs, and this product has been included in the National Medical Insurance Catalog (Class B). With the improvement of the diagnosis and treatment capacity for heart failure at the primary level, the market penetration space continues to expand.

The original research enterprise of levosimendan is Orion Corporation of Finland, and the original trade name is "Simdax". The expiration date of its core compound patent in major markets such as Europe and the United States is 2017, and the expiration date of the compound patent in China is 2016. The main dosage form of the original research product is injection, with the specification of 5ml:12.5mg, which has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. At present, there are 12 registration numbers of levosimendan API in China, among which 8 are in Status A (available for associated review and approval), and 7 generic varieties of levosimendan injection have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demand for impurity reference standards in the R&D and quality control process of levosimendan, CATO can provide a full set of impurity reference standards for this API. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All impurity reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support the consistency evaluation of generic drugs, impurity research and the establishment of quality standards.