Trimetazidine

Cardiovascular disease is the category of chronic diseases with the highest fatality rate globally, and abnormal myocardial energy metabolism is one of the core incentives for the progression of ischemic heart disease. Trimetazidine is a piperazine derivative, the first widely clinically recognized myocardial energy metabolism optimiser. Its mechanism of action is different from that of traditional nitrates or β-blockers. It selectively inhibits 3-ketoacyl coenzyme A thiolase, reduces myocardial free fatty acid oxidation, and in turn promotes glucose oxidation, so as to increase myocardial energy output under the same oxygen consumption without affecting the hemodynamic state. It is mainly used clinically for the preventive treatment of angina pectoris attacks, and can also be used as an auxiliary symptomatic medication for vertigo and tinnitus. The applicable population includes adult patients who are intolerant to traditional anti-angina drugs, or still have frequent ischemic symptoms after standardized medication.

The global trimetazidine market size was approximately USD 1.27 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain around 3.2%. The core growth drivers are the continuous increase in the number of patients with chronic coronary heart disease and the improvement of awareness of metabolic cardiovascular drugs in primary medical institutions. The domestic market is currently dominated by generic drugs. As of 2023, oral preparations from more than 20 enterprises have passed the consistency evaluation. In the 2021 provincial-level centralized procurement, the average price reduction of trimetazidine sustained-release dosage forms reached 68%, and the accessibility at the primary level has been greatly improved. On the API side, domestic production capacity accounts for more than 72% of the total global supply.

The original research enterprise of trimetazidine is Servier in France, and the original research brand name is "Vastarel". Its core compound patent expired globally in 2007, and the preparation patent in China also expired in 2009. The main dosage forms approved by the original research globally include 20mg conventional tablets and 35mg sustained-release tablets. Both dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and are also listed as FDA reference preparations. In terms of domestic API registration, as of October 2024, there are 17 trimetazidine API registration numbers on the CDE platform, of which 13 have been approved for use in marketed preparations, and more than 30 trimetazidine oral preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of trimetazidine impurity reference standards, covering all research dimensions such as process impurities and degradation impurities. Most products are in stock. Orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support the requirements of API registration and declaration, quality research and daily release testing.