Ethacrynic acid

Loop diuretics are the core drug category for the clinical management of edematous diseases. Compared with thiazide diuretics, they have stronger diuretic effect and faster onset of action, and have irreplaceable clinical value in scenarios such as severe edema, refractory heart failure combined with water and sodium retention. As a classic representative of loop diuretics, ethacrynic acid inhibits the Na+-K+-2Cl- cotransporter in the thick ascending limb of the medullary loop of renal tubules, reduces the reabsorption of sodium ions and chloride ions, and greatly increases urine excretion. It is mainly used for the treatment of edema caused by congestive heart failure, cirrhosis ascites and renal diseases, and can also be used for edema patients allergic to sulfonamide diuretics, filling the gap of clinical medication for specific allergic populations.

At present, the overall global market size of loop diuretics exceeds 3 billion US dollars. Among them, ethacrynic acid, due to its strong pertinence to the applicable population, accounts for about 3% of the overall loop diuretic market share. Driven by factors such as the rising prevalence of heart failure and the expansion of the elderly edema patient group in recent years, its annual compound market growth rate has remained at around 2.7%. In the domestic market, furosemide and torasemide are currently the main loop diuretic varieties, and the clinical application of ethacrynic acid is still in the stage of gradual promotion. The number of existing manufacturers is small, and it has not been included in the national centralized volume procurement catalogue, so the market competition pattern is relatively loose.

The original research enterprise of ethacrynic acid is Pfizer, and the original trade name is Edecrin. Its US compound patent expired in 1985. The main dosage forms approved by the original research include 25mg oral tablets and 50mg powder for injection. The original 25mg tablets have been included in the FDA Reference Listed Drug Catalogue, and this variety has not been included in the *Catalogue of Chemical Drugs* in China for the time being. According to the domestic API registration platform, no enterprise has submitted the marketing registration application for ethacrynic acid API at present. On the preparation side, only 25mg oral tablets from 1 enterprise were approved for marketing in 2011, and the clinical supply channels are relatively limited. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full series of impurity reference standards for ethacrynic acid, covering all research dimensions such as synthesis process impurities and degradation impurities. Most of the products are in stock regularly, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises in various scenarios such as quality research and registration declaration.