Isradipine

Hypertension is the chronic cardiovascular disease with the highest prevalence worldwide. Poor long-term control will significantly increase the risk of adverse events such as stroke and myocardial infarction. Calcium channel blockers are one of the core categories of first-line clinical antihypertensive regimens. Isradipine is a second-generation dihydropyridine calcium channel blocker, which can highly selectively block calcium influx in vascular smooth muscle, dilate peripheral arterial vessels while having minimal impact on cardiac conduction and myocardial contraction. It is mainly used clinically for the treatment of essential hypertension, especially suitable for patients with concomitant coronary heart disease and elderly isolated systolic hypertension. Long-term medication can stably control blood pressure fluctuations and reduce the risk of target organ damage.

At present, the global market size of isradipine is approximately USD 120 million, and the Chinese market size is approximately RMB 82 million. Driven by the rising prevalence of hypertension in the elderly and the popularization of combined medication regimens in recent years, the compound annual growth rate has remained at around 4.2%. The competitive landscape is dominated by generic drugs. At present, 12 domestic enterprises have obtained approval for isradipine preparation approval numbers. After centralized procurement, the terminal price has dropped by approximately 68%, and the demand of downstream preparation enterprises for cost-effective and compliant API continues to rise.

The original research enterprise of isradipine is Novartis, with the original research trade name "Dynacirc". Its US compound patent expired in 2003, and the core compound patent in China expired in 1999. The main dosage forms approved by the original research include tablets (2.5mg, 5mg) and sustained-release capsules (5mg, 10mg), which have been included in the FDA Reference Listed Drug Catalog, and are also included in the *Catalog of Reference Listed Drugs of Chemical Drugs (21st Batch)* of China. At present, there are 7 A-status registration numbers for isradipine API in China, and the approved preparation varieties cover two categories: conventional tablets and sustained-release capsules. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for isradipine API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API manufacturers in impurity research, quality control, registration and declaration, etc.