Ciprofibrate

Dyslipidemia is a core risk factor for cardiovascular diseases such as atherosclerosis and coronary heart disease. In clinical lipid-lowering therapy, fibrates are one of the preferred options for patients with hypertriglyceridemia and mixed dyslipidemia. Ciprofibrate is a phenoxyfibric acid lipid-regulating drug. It activates peroxisome proliferator-activated receptor α (PPARα) to enhance the activity of lipoprotein lipase and accelerate the catabolism of very low-density lipoprotein (VLDL) and triglycerides, while slightly increasing the level of high-density lipoprotein cholesterol (HDL-C). Clinically, it is mainly used for type Ⅱa, Ⅱb and Ⅳ hyperlipoproteinemia that is unresponsive to dietary control, especially suitable for dyslipidemia patients with comorbid diabetes.

In the global lipid-lowering drug market, fibrates, as an important supplement to statins, maintain stable demand in the hypertriglyceridemia segment. In 2023, the domestic market size of fibrate APIs was approximately RMB 420 million, with an annual compound growth rate of around 6%. As a third-generation fibrate product, ciprofibrate has better tolerance than first-generation products such as fenofibrate, so its market share is increasing year by year. At present, there are less than 5 domestic enterprises applying for its generic marketing, and the competitive landscape is relatively relaxed.

The original developer of ciprofibrate is Sanofi, France, with the original brand name "Lipanor". Its core European compound patent expired in 2002. The main dosage form approved for the original product is tablets with a specification of 100 mg per tablet, which has been included in the reference preparation catalog of the European Medicines Agency (EMA). Up to now, there is no ciprofibrate preparation approved for marketing in China, and no enterprise has submitted an A-status registration number for ciprofibrate on the CDE API registration platform, so the generic development of relevant domestic preparations is still in the early stage. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ciprofibrate API. All products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities are in regular stock, and orders placed before 16:00 can be shipped on the same day. They can fully meet the full-process requirements such as quality research and stability investigation in the generic drug development process, and help R&D enterprises accelerate the progress of project application.