Clevidipine

Acute hypertension is a common acute and critical illness in perioperative and emergency scenarios. If blood pressure is not controlled in time, it can cause irreversible damage to multiple organs such as the heart, brain and kidneys, and there is an urgent clinical need for intravenous antihypertensive drugs with rapid onset and controllable metabolism. Clevidipine is a third-generation dihydropyridine calcium channel blocker. It selectively blocks L-type calcium channels in vascular smooth muscle, dilates peripheral arterial vessels to lower blood pressure, and does not affect myocardial contractility and atrioventricular conduction. Its half-life is only 1 minute, and blood pressure can quickly return to the baseline level after drug withdrawal. It is mainly used for patients with acute hypertension who are unsuitable for oral administration or do not respond to oral antihypertensive therapy, especially suitable for perioperative blood pressure control and rapid management of hypertensive emergencies, and is an important choice for clinical short-acting intravenous antihypertensive therapy.

Data show that the global market size of intravenous antihypertensive drugs for acute hypertension has exceeded 1.8 billion US dollars, with a compound annual growth rate of 7.2% in the past five years, among which ultra-short-acting calcium channel blockers account for more than 35%. In terms of the domestic market, the overall share of clevidipine is continuously increasing. At present, a number of pharmaceutical companies have deployed generic drug development. After the implementation of centralized procurement, its clinical utilization rate has increased by more than 120% compared with that before centralized procurement. With the popularization of perioperative blood pressure management specifications, the domestic market growth rate is expected to remain above 15% in the next three years.

The original research enterprise of clevidipine is AstraZeneca, with the original trade name Cleviprex. Its core compound patent in the United States expired in 2019, and the compound patent in China expired in 2021. The dosage form approved for the original research is injectable emulsion, with common specifications of 50ml:50mg and 100ml:100mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, more than 10 enterprises have obtained CDE registration numbers for clevidipine APIs, most of which are in Status A, and a number of domestic enterprises have obtained marketing approval for clevidipine injectable emulsion. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for clevidipine API, covering all categories such as process impurities and degradation impurities. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the use needs of different scenarios such as API R&D, quality research, and consistency evaluation.