Danazol

In response to the chronic pelvic pain, dysmenorrhea and other symptoms caused by endometriosis, which have long troubled more than 30 million women of childbearing age worldwide, traditional hormone therapy regimens often face the clinical pain point of high incidence of adverse reactions. Danazol, a gonadotropin-inhibiting heterocyclic steroid drug, inhibits the function of the pituitary-gonadal axis to reduce the release of follicle-stimulating hormone and luteinizing hormone, thereby lowering estrogen levels and causing atrophy of ectopic endometrium. In addition to endometriosis, it can also be used to treat hereditary angioedema, fibrocystic breast disease, gynecomastia and other conditions, and the applicable population covers patients who have been long troubled by the above-mentioned diseases and have no hormonal contraindications.

At present, the global danazol market size is approximately USD 120 million in 2024. Driven by the expansion of the hereditary angioedema indication, the compound annual growth rate of the market remains at around 3.2%. In terms of the domestic market, there are more than 10 enterprises producing danazol preparations at present, and the concentration of API supply is relatively high, with the top 3 enterprises occupying more than 80% of the market share. After the implementation of the centralized procurement policy, the terminal price of preparations has dropped by more than 65%, and the clinical accessibility has been greatly improved, driving the demand for APIs to grow steadily year by year.

The original research enterprise of danazol is Sanofi, with the original brand name Danocrine, and the core compound patent expired in 1989. The original dosage forms that have been marketed in China are mainly capsules, with specifications of 100mg and 200mg. This product has been included in the FDA Reference Listed Drug Catalog, while the original research preparation has not been imported or marketed in China. At present, 7 enterprises have obtained marketing approval for danazol capsules. The CDE API registration platform shows that there are a total of 5 danazol API registration information at present, among which 3 are in activated status and eligible for associated review. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of danazol impurity reference standards. Most products are in stock, and for in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of API enterprises in all links of R&D and quality control.