Azilsartan

As the chronic cardiovascular disease with the highest prevalence in the world, hypertension always has renin-angiotensin-aldosterone system (RAAS) inhibitors as the first-line medication option in clinical treatment. Azilsartan is a new generation of selective angiotensin Ⅱ type 1 receptor (AT1) antagonist. It blocks the binding of AT1 receptor to angiotensin Ⅱ with high affinity, inhibits vasoconstriction and aldosterone release, exerts a long-acting and stable antihypertensive effect, and has a lower incidence of adverse reactions. This drug is mainly used for the treatment of adult primary hypertension, especially suitable for hypertension patients with concurrent target organ damage (such as left ventricular hypertrophy, renal insufficiency), and can effectively reduce the risk of cardio-cerebrovascular events.

In recent years, the global market size of antihypertensive drugs has maintained steady growth, among which azilsartan has continued to increase its market share by virtue of its clinical advantages. In 2023, the global market size of azilsartan-related preparations was approximately USD 1.48 billion, with a compound annual growth rate of around 7.2%. In the domestic market, with the advancement of the centralized procurement policy, the generic drug substitution process has accelerated. At present, more than 10 domestic enterprises have obtained approval for the marketing of generic azilsartan preparations, and local enterprises have gradually become the main force in the API supply side. In 2023, the domestic market size of azilsartan API exceeded RMB 320 million, and it is expected to maintain a growth rate of more than 8% in the next three years.

The original research enterprise of azilsartan is Takeda Pharmaceutical of Japan, and the original brand name is "Edarbi/艾可拓". The core compound patent will expire in 2025 in major markets such as Japan and the United States, and the compound patent in China expired in 2021. The main dosage form of the original drug is tablet, with specifications including 20mg, 40mg and 80mg. The original tablet has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also listed in the FDA Reference Preparations Catalogue. Up to now, there are 23 azilsartan API registration entries on the API registration platform of China CDE, among which 16 are registered with the status of "A" (approved for use in marketed preparations). Multiple preparation varieties such as azilsartan tablets and azilsartan medoxomil tablets have been approved for marketing in China. (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 azilsartan API. Most products are available directly from stock. Stock orders paid before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with complete data on impurity structure confirmation and purity calibration, which can directly support API registration, declaration and quality research work.