Estriol

As a commonly used clinical drug for the management of menopause-related symptoms, estriol is a natural short-acting estrogen drug that can selectively act on the urogenital mucosa. It binds to estrogen receptors to promote the proliferation of vaginal epithelial cells and repair the mucosal barrier, while not causing significant proliferative stimulation to the endometrium, so it has higher safety compared with other estrogens. Clinically, it is mainly used to treat atrophic vaginitis and urinary tract infections in postmenopausal women, as well as to relieve vasomotor symptoms such as hot flashes and night sweats during menopause. It can also be used as an adjuvant therapy to prevent postmenopausal osteoporosis, and its applicable population is mainly perimenopausal and postmenopausal women.

The global estriol market size is approximately USD 320 million, with a compound annual growth rate of about 4.1% from 2023 to 2029. The growth momentum mainly comes from the intensification of global population aging, the expansion of the size of the postmenopausal female group, and the improvement of women's awareness of health management. Generic drugs dominate the domestic market. At present, estriol-related preparations from more than 20 enterprises have been approved for marketing. In 2022, the terminal sales in public medical institutions exceeded RMB 230 million. With the improvement of diagnosis and treatment pathways for gynecological and urinary diseases, the market demand still has room for continuous growth.

The original research enterprise of estriol is Organon, and the original research brand name is Ovestin. Its core compound patent expired in the 1980s. The main dosage form of the original research product is estriol cream with the specification of 15g:15mg, which has been included in the *Catalogue of Chemical Drugs* of China and listed as a reference preparation by the FDA. In terms of domestic API registration, as of now, estriol APIs from more than 6 enterprises have obtained CDE registration numbers, among which more than 4 are in A status. Multiple domestic manufacturers have obtained approval for the marketing of estriol preparations such as creams and suppositories. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for estriol API, covering the full chain requirements including starting materials, intermediates and degradation impurities. Most of the products are in regular stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various testing needs of pharmaceutical enterprises in R&D, quality research and production release.