Acipimox

Dyslipidemia is a core risk factor for atherosclerosis and cardiovascular diseases, and there has long been unmet demand in clinical treatment for hypertriglyceridemia and low high-density lipoprotein cholesterolemia. Acipimox is a nicotinic acid lipid-regulating drug. By inhibiting the lipolysis of adipose tissue, it reduces the release of free fatty acids and decreases the synthesis of triglycerides in the liver. Meanwhile, it can increase the level of high-density lipoprotein cholesterol. It is currently the only lipid-regulating drug that can simultaneously lower lipoprotein a. Clinically, it is mainly used for the treatment of hypertriglyceridemia, hypercholesterolemia and mixed hyperlipidemia, and is especially suitable for patients with dyslipidemia who are intolerant to statins or have poor control effect with statins alone.

At present, the global market size of lipid-regulating drugs exceeds 40 billion US dollars. Among them, nicotinic acid drugs account for about 3% by virtue of their unique action targets. As a variety with more controllable adverse reactions in this category, acipimox has achieved a global market compound annual growth rate of 5.2% in the past three years. In terms of the domestic market, the terminal sales of acipimox in public medical institutions exceeded 210 million yuan in 2023. With the continuous rise in the prevalence rate of people with dyslipidemia, the growth rate is expected to remain above 6% in the next two years. At present, the domestic generic drug market has gradually occupied a dominant position, with a total of 12 enterprises holding the approval documents of acipimox preparations. After winning the bid in the centralized procurement, the demand for API has increased by about 170% compared with that before the centralized procurement, and the stability of the supply chain has become the core concern of downstream preparation enterprises.

The original research enterprise of acipimox is Pfizer, and the original brand name is "乐知苹/Olbemox". Its core compound patent expired globally in 2001. The dosage forms approved by the original research include capsules and sustained-release tablets, with the mainstream specifications being 250mg regular capsules and 500mg sustained-release tablets. Among them, the 250mg capsule has been included in the Catalogue of Marketed Drugs in China as a reference preparation, and is also listed in the FDA Reference Preparation Catalogue. Up to now, a total of 18 acipimox API registration entries have been included in the API Registration Platform of China CDE, of which 9 have obtained A status. Multiple domestic manufacturers have obtained approval for the marketing of acipimox capsules and sustained-release tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of acipimox impurity reference standards. All series of products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most impurities are in sufficient stock. For stock orders placed before 16:00, delivery can be made on the same day, which can provide reliable reference material support for API and preparation enterprises in the links of quality research, stability study, registration and declaration, etc.