Prasterone

Cervical dysfunction related to perimenopause and childbirth is a common clinical gynecological and obstetric problem. Such conditions often lead to cervical maturation disorders due to insufficient endogenous androgen secretion, which greatly increases the risk of adverse pregnancy outcomes or perimenopausal symptoms. Prasterone is an adrenocortical hormone androgen prodrug. After entering the human body, it can be converted into estrogen through local metabolism without going through the systemic metabolic circulation. It can specifically promote the proliferation of fibroblasts in cervical tissue and the decomposition of collagen fibers, soften and dilate the cervix, and regulate the hormone level fluctuations of perimenopausal women. Clinically, it is mainly used for adjuvant treatment of labor induction in patients with incomplete cervical maturation in late pregnancy, and for the improvement of hypoestrogenic symptoms related to perimenopausal syndrome. The applicable population covers full-term pregnant women with labor induction indications and middle-aged female groups with perimenopausal symptoms such as hot flashes and night sweats.

At present, the global prasterone market size is about 180 million US dollars, and the compound annual growth rate remains at around 4.2%. The growth momentum mainly comes from the steady increase in demand for obstetric labor induction and the popularization of perimenopausal health management awareness. The Chinese market accounts for 19% of the global share, of which generic drugs account for more than 85%. Local enterprises have formed a dominant advantage in the supply end of active pharmaceutical ingredients (APIs). Only 3 enterprises have compliant API registration qualifications, the market competition pattern is relatively concentrated, and no centralized procurement-related policies have covered this variety yet.

The original research enterprise of prasterone is Mitsubishi Tanabe Pharma of Japan, and the original research brand name is "Mylis". Its core compound patent expired globally in 2010. The main dosage form approved for the original research is prasterone sodium sulfate for injection, with a specification of 100 mg per vial. It has been included in the Chinese *Catalogue of Chemical Reference Preparations* and also included in the FDA Reference Preparations Catalogue. In China, generic preparations from 6 enterprises have been approved for marketing. 3 valid A-status registration numbers can be found on the API registration platform, all of which are approved by local enterprises. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of prasterone impurity reference standards. Most products support spot supply. Spot orders paid before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises in quality research, impurity calibration and registration declaration.