Promestriene

Atrophic genital tract diseases caused by decreased estrogen levels in postmenopausal women are common diagnosis and treatment needs in gynecological clinical practice. As a topical estrogen drug, promestriene provides a treatment option with low systemic exposure for such patients. Its mechanism of action is to exert estrogen-like effects locally on the vaginal mucosa, promote the repair of genital tract mucosal epithelium, and regulate the local microenvironment. Meanwhile, since the drug is rarely absorbed into the systemic circulation, it will not produce estrogen effects on other organs of the whole body. It can not only effectively improve the symptoms related to vulvar and vaginal atrophy such as dryness, itching, and dyspareunia, but also avoid the potential risks of systemic estrogen therapy. It is suitable for postmenopausal women and people with genital tract atrophy caused by estrogen deficiency due to other reasons, and can also be used for vaginal mucosa preparation before and after gynecological surgery.

The global market size of promestriene maintains a steady growth trend. In 2023, the global market size was approximately USD 280 million, with a compound annual growth rate of around 4.2%. Benefiting from the increasing health needs of the menopausal population and the improvement of the standardization of clinical gynecological medication in the domestic market, the market growth rate has remained above 6% in the past 3 years. Currently, the market is dominated by original research products, and a number of domestic pharmaceutical companies have started the R&D of generic drugs. With the advancement of the consistency evaluation of generic drugs, the market share of domestic preparations is gradually increasing.

The original research enterprise of promestriene is Merck KGaA in France, with the original trade name "Colpotrophine". Its core compound patent expired in 2007 in major markets such as Europe and the United States, and the compound patent in China has also expired and become invalid. The main dosage forms approved for the original research are vaginal soft capsules (10 mg per capsule) and cream (1% concentration, 15 g per tube). Both dosage forms have been included in the Catalogue of Marketed Drugs in China, and are used as the reference preparations for this variety. As of now, there are 5 promestriene API registration information on the API registration platform of the Center for Drug Evaluation (CDE) of China, among which 3 have obtained A status through joint evaluation with preparations. Multiple domestic manufacturers have obtained marketing approval for promestriene soft capsules and cream preparations 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 promestriene API. All products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities have sufficient spot inventory. Spot orders placed before 16:00 can be shipped on the same day, which can efficiently meet the demand for impurity reference standards in the process of pharmaceutical R&D, quality research and production.