Fezolinetant

As the first orally administered neurokinin-3 (NK3) receptor antagonist approved worldwide, fezolinetant reversibly blocks NK3 receptors on KNDy neurons in the hypothalamus, reduces the pulsatile secretion of gonadotropin-releasing hormone, and thereby lowers the production levels of ovarian estrogen and progesterone. This drug is mainly indicated for the treatment of moderate to severe menopause-related vasomotor symptoms (hot flashes), providing a brand-new non-hormonal treatment option for perimenopausal women who are intolerant to hormone replacement therapy or have contraindications to hormone therapy, and greatly reducing the risks of thrombosis and breast diseases caused by traditional hormone regimens.

The global market size related to fezolinetant had exceeded USD 470 million in 2023, and the compound annual growth rate is expected to remain above 21% by 2028. The core growth drivers are the continuous release of treatment demands from the perimenopausal population and the increasing penetration rate of non-hormonal treatment regimens. At present, the global market is still dominated by the original research product, and generic drug enterprises in China, India and other countries have successively launched bioequivalence studies. With the expiration of core patents, the launch of generic versions in the next 3-5 years is expected to further reduce the medication burden of patients and drive the rapid expansion of the market size.

The original research enterprise of fezolinetant is AstraZeneca, and the original brand name is Veozah. Its core compound patent will expire in 2030 in China, and the core patent for the US market will expire in 2031. The currently approved main dosage form is oral tablet, with a specification of 45 mg. The original research preparation has been included in the FDA Reference Listed Drug Catalog, and was approved for import and marketing by the China NMPA in 2023. In terms of domestic API registration, there is no approved API registration number with A status at present, and 3 enterprises have submitted API DMF registration applications which are under the review stage. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for fezolinetant API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable and reliable reference standard support for impurity control in drug R&D declaration, quality research and production processes.