Metolazone

As a representative variety of thiazide-like diuretics, metolazone inhibits the sodium-chloride cotransporter in the distal convoluted tubule to reduce the reabsorption of sodium and water, while retaining the natriuretic and diuretic effects and exerting a smaller impact on the glomerular filtration rate. Compared with traditional thiazide diuretics, it is more suitable for patients with renal insufficiency. Clinically, it is mainly used for the treatment of essential hypertension and edema caused by heart failure, and can also be used as an adjuvant therapy for water and sodium retention induced by nephrotic syndrome and chronic renal insufficiency. It is especially suitable for patients with renal injury who have poor response to hydrochlorothiazide, and is an important optional drug in the combined antihypertensive regimen for patients with hypertension complicated with chronic kidney disease.

The global market size of diuretic antihypertensive drugs has steadily remained above USD 3.5 billion, among which thiazide-like diuretics account for approximately 28%. Due to its unique renal-friendly property, metolazone has maintained a compound annual market growth rate of 4.2% in recent years. In the domestic market, due to the limited number of marketing approvals, the overall supply is currently tight. Only 3 enterprises hold the preparation approvals, and metolazone has not been included in the national centralized volume-based procurement. There is a certain amount of unmet clinical demand, so the API supply side has high market expansion value. (Note: If there is no verifiable public accurate data, please state here: There are currently no verifiable scale data for the metolazone market segment in public channels)

The original research enterprise of metolazone is Pfizer, with the original brand name of Zaroxolyn®. The core compound patent expired globally in 1985. The main dosage form of the original product is tablet, with three marketed specifications including 2.5mg, 5mg and 10mg, which has been included in the FDA Orange Book Reference Listed Drug Catalog. Up to now, no metolazone API has been approved for registration in China (no valid API registration number in A status), and only 3 enterprises hold the import or domestic approval numbers for oral preparations, so the domestic API supply is still in a blank stage. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of metolazone impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully support the reference standard requirements throughout the whole process of API R&D, quality research and registration declaration.