Colesevelam

Hyperlipidemia is a chronic metabolic disease with high incidence worldwide. Long-term dyslipidemia will significantly increase the risk of cardiovascular events such as atherosclerosis and coronary heart disease, and the clinical demand for efficient and well-tolerated lipid-lowering drugs continues to rise. Colesevelam is a non-absorbable polymer bile acid sequestrant lipid-lowering drug. Its mechanism of action is to specifically bind to bile acids in the intestinal tract, block the enterohepatic circulation of bile acids, prompt the liver to consume more cholesterol to synthesize new bile acids, and thereby reduce the level of low-density lipoprotein cholesterol (LDL-C) in the blood. In addition to being used as an adjuvant therapeutic drug with diet and exercise for primary hyperlipidemia, it can also be used alone or in combination with lipid-lowering drugs such as statins and ezetimibe. Meanwhile, it has also been approved for improving glycemic control in patients with type 2 diabetes mellitus, and its applicable population covers adult patients with dyslipidemia with or without glucose metabolism disorders.

At present, the global colesevelam-related market size is growing steadily. In 2023, the global market size was approximately USD 480 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the improvement of the diagnosis and treatment penetration rate of hyperlipidemia at the primary level and the increase in the demand for combined medication among people with diabetes complicated with dyslipidemia. In terms of the competitive landscape, the original research product still accounts for about 62% of the global market share, and the United States and the European Union are the core consumer markets; the domestic market is currently in the initial stage of import substitution, and 3 domestic enterprises have submitted marketing applications for generic drugs. With the expansion of the coverage of chronic disease medication under the centralized procurement policy, the market share of generic drugs is expected to gradually increase in the future.

The original research enterprise of colesevelam is Vectren Pharmaceuticals in the United States, and the original research brand name is WelChol. The core US compound patent of the original research product expired in 2015, and the Chinese compound patent also expired in 2015. The main dosage forms approved for the original research product are oral tablets, with specifications including 625 mg/tablet and 1.875 g/sustained-release tablet. It has been included in the FDA Orange Book Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Listed Drugs for Chemical Drugs (Third Batch)*. Up to now, there are 2 registration entries of domestic colesevelam active pharmaceutical ingredients on the API registration platform of China Center for Drug Evaluation (CDE), both with the status of "A" (approved for use in marketed preparations), and 2 domestic enterprises have obtained marketing approval for colesevelam generic drug preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of colesevelam impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA at the same time, and provide stable reference standard support for API R&D, quality research and generic drug consistency evaluation.