Epristeride

Benign prostatic hyperplasia (BPH) is a high-incidence urinary system disease among middle-aged and elderly men. Its incidence increases with age, reaching 50% in people over 50 years old, and severe cases can cause complications such as urinary retention and renal function impairment. Epristeride is a new type of selective 5α-reductase inhibitor. It can irreversibly block the conversion of testosterone to dihydrotestosterone, reduce the content of dihydrotestosterone in the prostate, thereby shrinking the volume of the hyperplastic prostate and significantly improving lower urinary tract symptoms such as dysuria and frequent urination. Clinically, it is mainly used for the treatment of benign prostatic hyperplasia at all stages, and is suitable for middle-aged and elderly patients who have no surgical indications or need to reduce the prostate volume before surgery. Compared with non-selective drugs of the same category, it has less impact on normal physiological functions and a lower incidence of adverse reactions.

The market size of anti-prostatic hyperplasia drugs in China has exceeded 9 billion yuan, of which 5α-reductase inhibitors account for about 32%, and they are the core category for long-term drug treatment of BPH. Epristeride, as a drug of this category independently developed in China, has maintained a market growth rate of about 8% in recent years. At present, the preparations marketed in China are mainly generic drugs, which have been included in the National Medical Insurance Catalog (Class B). In the sixth batch of national centralized drug procurement, the average price reduction of epristeride tablets exceeded 60%, the supply of winning bidders covers most provinces across the country, and the accessibility in the primary market has been greatly improved, driving a steady increase in the demand for APIs.

The original research enterprise of epristeride is Jiangsu Lianhuan Pharmaceutical Co., Ltd., with the original brand name "Chuanliu". The core compound patent expired in 2021. At present, the mainstream dosage form marketed in China is tablet with a specification of 5mg, and the original preparation has been included in the *Reference Preparation Catalog of Chemical Drugs* issued by the National Medical Products Administration. Up to now, the CDE API Registration Platform has included a total of 3 epristeride API registration information, of which 2 have passed the A-status public notification, and 7 domestic enterprises have obtained approval for the marketing of epristeride generic preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for epristeride API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs in the stages of API R&D, quality research and consistency evaluation.