Lacidipine

Hypertension is the chronic cardiovascular disease with the highest prevalence worldwide. Long-term poor blood pressure control will significantly increase the risk of myocardial infarction, stroke and renal failure, and there is an urgent clinical need for therapeutic drugs with both long-acting and stable antihypertensive effects and target organ protection. Lacidipine is a third-generation dihydropyridine calcium channel blocker. It highly selectively blocks L-type calcium channels on the membrane of vascular smooth muscle cells, reduces calcium ion influx, and dilates peripheral arterial vessels, thereby continuously reducing peripheral resistance to achieve antihypertensive effects. Due to its high lipophilicity, it can be slowly released in the lipid layer of the vascular smooth muscle cell membrane, and its antihypertensive effect can last for 24 hours and is not easy to cause reflex tachycardia. In addition to the routine treatment of essential hypertension, it is especially suitable for patients with combined atherosclerosis and elderly isolated systolic hypertension.

In recent years, the global market size of antihypertensive API has continued to expand, among which the annual compound growth rate of long-acting calcium channel blocker API has remained at around 4.2%. With its unique clinical advantages, the overall market demand for lacidipine has grown steadily. In 2023, the sales volume of lacidipine preparations at the terminal of domestic public medical institutions exceeded 800 million yuan. At present, the market competition concentration of its generic drugs is relatively high. Nearly 10 domestic enterprises have passed the consistency evaluation for lacidipine tablets, and the winning bid price in centralized procurement has a maximum decrease of more than 70% compared with the original research drug. With the further penetration of the grassroots hypertension drug market, the rigid demand attribute of upstream API continues to be prominent.

The original research enterprise of lacidipine is GlaxoSmithKline, and the original brand name is "Lacipil". Its core compound patent expired in China in 2012. The main dosage form of the original research drug approved in China is tablet, with specifications of 4mg and 2mg. It has been included in the *National Catalogue of Medicines for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance*, and is also the reference preparation of domestic lacidipine preparations, which is included in the Catalogue of Reference Preparations for Chemical Drugs issued by the National Medical Products Administration. Up to now, more than 15 domestic enterprises have obtained A status for their lacidipine API through CDE registration, which can be associated with the marketing application or change of downstream preparations, and the supply of domestic API has achieved independent controllability. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for lacidipine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs in various links such as API R&D, quality research, and registration application.