Terazosin

Benign prostatic hyperplasia (BPH) and hypertension are high-prevalence chronic diseases among the middle-aged and elderly population. Previously, commonly used clinical drugs often had limitations such as slow onset of action and frequent adverse reactions. The advent of α₁ adrenoceptor blockers has provided a better option for the treatment of these two types of diseases. As a highly selective α₁ receptor blocker, terazosin can block the α₁ receptors on the surface of smooth muscles in the prostate and bladder neck, relax smooth muscles, and relieve lower urinary tract symptoms such as dysuria, frequent urination and urgent urination caused by BPH. At the same time, it can dilate peripheral blood vessels, reduce peripheral vascular resistance, and achieve the effect of stable blood pressure reduction. It is especially suitable for BPH patients with comorbid hypertension, has been clinically applied for more than 30 years, and its safety and effectiveness have been fully verified.

The global terazosin market size is stable at around USD 1.2 billion, with a compound annual growth rate of approximately 2.3%, and the growth mainly comes from the expansion of the base of BPH and hypertension patients under the process of aging. The market size in China is approximately RMB 870 million, among which public hospital channels account for 62% and retail channels account for 38%. In terms of the competitive landscape, the original research product accounts for about 28% of the global market share, and generic drugs account for more than 70%. More than 30 generic drug preparations have been approved for marketing in China, among which 27 products have passed the consistency evaluation. After centralized procurement, the price of preparations has dropped by more than 85%, the demand for upstream API is stable, and multiple domestic enterprises have realized localized supply of API.

The original research enterprise of terazosin is Abbott Laboratories, and the original research brand name is Hytrin. The core compound patent in the United States expired in 2003, and the compound patent in China expired in 2001. The original research dosage forms include tablets and capsules, with specifications covering three commonly used specifications of 1mg, 2mg and 5mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, terazosin APIs from 12 enterprises have currently obtained Class A status through CDE registration, and can be legally supplied to domestic preparation manufacturers. More than 40 terazosin oral preparation varieties have 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 terazosin API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can meet the application needs of the whole process including API R&D, quality research, registration and declaration, etc.