Cyproterone

In the clinical treatment of androgen-dependent diseases such as polycystic ovary syndrome, hirsutism and prostate cancer, anti-androgen drugs have always been the core medication option. As a 17-hydroxyprogesterone derivative, cyproterone is a potent steroidal anti-androgen drug. It can block the effect of dihydrotestosterone by competitively binding to androgen receptors, and at the same time inhibit the secretion of gonadotropin to reduce androgen synthesis. Clinically, it can be used alone for the treatment of male paraphilia and severe androgenization symptoms in women, and can also be combined with estrogen to form a compound preparation for female contraception and improvement of acne and hirsutism symptoms caused by polycystic ovary syndrome. It is one of the most widely used anti-androgen drugs in clinical practice at present.

The global cyproterone market size has maintained a stable growth trend for a long time. In 2023, the market size was approximately USD 380 million, with a compound annual growth rate maintained at around 4.2%. China's market accounts for approximately 17% of the global market. With the increase in the diagnosis rate of polycystic ovary syndrome and the growth in demand for prostate cancer treatment, the growth rate is higher than the global average. It is estimated that the domestic market size will exceed USD 120 million by 2025. In terms of the competitive landscape, European enterprises dominate the original research and high-end preparation markets, while domestic generic pharmaceutical enterprises currently focus on preparation production, and there is still considerable room for domestic substitution in the supply of active pharmaceutical ingredients.

The original research enterprise of cyproterone is Bayer Pharma, and the original research brand name is "Androcur". Its core compound patent expired globally in 1999. The main dosage forms approved for the original research product include tablets, creams and compound oral contraceptives. Among them, the tablets have two specifications of 10mg and 50mg, and the relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, 3 A-status registration numbers of cyproterone APIs have been publicized on the CDE platform up to now, and cyproterone tablets and compound preparations from a number of other domestic enterprises have also been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for cyproterone API, which can fully meet the needs of impurity qualitative and quantitative research in different R&D stages. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for API and preparation enterprises in the whole process of R&D, registration and production.