Trandolapril

Excessive activation of the renin-angiotensin-aldosterone system (RAAS) is one of the core pathological mechanisms for the progression of cardiovascular diseases such as hypertension and heart failure. As a third-generation long-acting angiotensin-converting enzyme inhibitor (ACEI), trandolapril highly specifically inhibits the activity of angiotensin-converting enzyme to reduce the production of angiotensin II, and meanwhile inhibits the degradation of bradykinin, exerting multiple effects including dilating blood vessels, improving ventricular remodeling and protecting target organs. It is mainly used clinically for the treatment of essential hypertension and heart failure, especially suitable for hypertensive patients complicated with myocardial infarction or diabetic nephropathy, and can significantly reduce the incidence of major adverse cardiovascular events. Once-daily administration can maintain stable blood pressure lowering for 24 hours, leading to higher patient compliance.

The continuous rise in the global prevalence of hypertension drives the steady growth of market demand for RAAS inhibitors. At present, the global market size of trandolapril is approximately USD 420 million, with a compound annual growth rate of 3.7% in the recent three years. In terms of the domestic market, with the expansion of the hypertension patient base and the consolidation of the first-line recommendation status of ACEIs in guidelines, the growth rate of the trandolapril preparation market is higher than the global average, with a compound annual growth rate of 6.2%. The current market is still dominated by the original research product, and the generic drug market is in the initial stage. There are only 3 preparation enterprises in China that have passed the consistency evaluation, and the supply gap of upstream API is relatively obvious.

The original research enterprise of trandolapril is Abbott, with the original brand name Mavik. Its core US compound patent expired in 2010, and the Chinese compound patent expired in 2008. The main dosage form approved for the original research product is tablet, with specifications including 0.5mg, 1mg and 2mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and is also collected in the *Catalog of Reference Preparations for Chemical Drugs (5th Batch)* of China. According to the domestic API registration platform, at present, 6 enterprises have obtained A-status registration numbers for trandolapril APIs, and a total of 4 enterprises have obtained marketing approval for trandolapril tablets, among which 3 have passed the generic drug consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of trandolapril impurity reference standards, covering all impurity types involved in the synthesis process and degradation pathways. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, with complete and traceable data of structure confirmation and purity testing. Most of the products are in stock. For in-stock orders paid before 16:00, delivery can be made on the same day, which can quickly match the supply demands of different stages such as API R&D, quality research and consistency evaluation, effectively shortening the impurity research cycle.