Candesartan Cilexetil

Hypertension is one of the chronic cardiovascular diseases with the highest prevalence worldwide, and the number of adult patients in China has exceeded 270 million. The over-activation of the renin-angiotensin-aldosterone system (RAAS) is one of the core pathological mechanisms of elevated blood pressure. Candesartan cilexetil belongs to the angiotensin Ⅱ receptor antagonist (ARB) class of antihypertensive drugs. As a prodrug, it is rapidly hydrolyzed into the active metabolite candesartan after absorption in the gastrointestinal tract. By selectively blocking the binding of angiotensin Ⅱ to the AT1 receptor, it inhibits vasoconstriction and aldosterone release, thereby exerting a stable antihypertensive effect. Meanwhile, it also has cardiac and renal protective effects, and is suitable for patients with essential hypertension, especially for hypertensive populations complicated with diabetic nephropathy and left ventricular hypertrophy.

Currently, in the global antihypertensive drug market, ARB drugs account for approximately 22% of the market share, among which the global annual market size of candesartan cilexetil is close to 1.5 billion US dollars, and its domestic market size exceeds 1.8 billion RMB. With the continuous rise in the prevalence of hypertension and the improvement of patients' long-term medication adherence, its market size maintains an annual growth rate of around 3%. In terms of the competitive landscape, with the expiration of core patents, the number of applications from domestic generic pharmaceutical enterprises has exceeded 30, among which 17 enterprises have had their preparation products pass the consistency evaluation. In provincial centralized procurement, the average price reduction of its preparations exceeds 60%, and the overall market has entered a mature stage of full competition.

The original research enterprise of candesartan cilexetil is Takeda Pharmaceutical Company Limited of Japan, and the original brand name is Blopress®. Its core compound patent expired in 2011 in the United States and Europe, and the Chinese compound patent expired in 2012. The main dosage form approved by the original research enterprise is tablets, with specifications including 4mg, 8mg and 16mg. The original research tablets have been included in the Catalogue of Listed Drugs of China as reference preparations, and are also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, 29 domestic enterprises have obtained A status for their candesartan cilexetil APIs through CDE registration, and 2 enterprises have obtained A status for imported API registration. Multiple domestic enterprises have had their candesartan cilexetil preparations approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for candesartan cilexetil. Most products are in stock and can be shipped on the same day if the order is placed before 16:00 on the same day. All impurities comply with the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can fully meet various reference standard needs in the process of API research and development, quality research and compliance declaration.