Cilazapril

Cardiovascular diseases are chronic non-communicable diseases with high incidence globally, and renin-angiotensin-aldosterone system (RAAS) inhibitors are one of the core categories for the treatment of hypertension and chronic heart failure. Cilazapril belongs to long-acting angiotensin-converting enzyme inhibitors (ACEI). It inhibits the activity of angiotensin-converting enzyme to reduce the production of angiotensin Ⅱ, and at the same time inhibits the degradation of bradykinin, thus exerting multiple effects of dilating blood vessels, reducing peripheral resistance and improving ventricular remodeling. Clinically, it is mainly used for the treatment of essential hypertension and renal hypertension, and can also be used as an adjuvant therapeutic agent for chronic heart failure. Its applicable population covers hypertension patients with mild to moderate renal insufficiency, as well as cardiovascular disease patients with poor tolerance to other ACEI drugs.

Driven by the continuous rise in the global prevalence of hypertension and the growing demand for the treatment of chronic heart failure, the overall market size of ACEI drugs to which cilazapril belongs has remained stable in recent years. The market size of the cilazapril segment is approximately 320 million yuan, with a compound annual growth rate maintained at around 2.8%. At present, the market is dominated by the original research product, and the number of approved domestic generic drugs is small, so the overall competitive landscape is relatively loose. As the R&D progress of generic drugs accelerates after the expiration of the original research patent, the market accessibility will be further improved in the future.

The original research enterprise of cilazapril is Roche, and the original research trade name is "Inhibace". Its core compound patent expired in 2011. The main dosage form of the original research product is tablet, covering two common specifications of 2.5mg and 5mg. The original research preparation has been included in the Chinese *Catalogue of Chemical Reference Preparations* and also included in the FDA Reference Preparation Catalogue. Up to now, no valid A-status registration number of cilazapril API has been found on the domestic API registration platform. A number of domestic enterprises have submitted marketing applications for generic cilazapril tablets, but no generic drug has been officially approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

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