Tienilic Acid

As an important branch of diuretic antihypertensive drugs, tienilic acid specifically inhibits the uric acid transporter URAT1 in the proximal renal tubule. While promoting sodium and water excretion and reducing peripheral vascular resistance, it also has the clinical value of reducing uric acid reabsorption. Different from the adverse reaction of traditional thiazide diuretics that easily induce hyperuricemia, tienilic acid is more suitable for patients with essential hypertension complicated with hyperuricemia. It can simultaneously achieve blood pressure control and regulation of blood uric acid level, effectively reduce the superimposed risk of gout attacks and cardiovascular events, and provide a differentiated medication option for the clinical hypertensive population with metabolic abnormalities.

At present, the scale of China's domestic antihypertensive drug market has exceeded 100 billion yuan, diuretics account for about 8% of the overall antihypertensive drug market, and the annual compound growth rate of the segmented track of new diuretics with uric acid-lowering effect reaches 12.7%. As a representative variety in this segmented field, there are currently no local enterprises in China that have achieved large-scale production of tienilic acid, and clinical demand has long relied on imported API, with a market supply gap of about 23 tons per year. With the continuous rise in the prevalence of hypertension complicated with hyperuricemia in China, the future market expansion space is considerable.

The original research enterprise of tienilic acid is SmithKline Beecham in the United States, with the trade name Tienilic Acid, and its core compound patent expired worldwide in 1982. The main dosage form approved by the original research is oral tablet, with a specification of 125 mg per tablet. This original research dosage form has been included in the FDA Orange Book Reference Listed Drug Catalog. Up to now, no valid API registration number of tienilic acid has been found on the API registration platform of China CDE, and no preparation product of this variety has been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for tienilic acid, most of which are in stock regularly. Orders placed before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, can fully meet the reference standard use needs in the links of API R&D, quality research and production, and provide stable technical support for the project advancement of relevant enterprises.