Relugolix

For the clinical treatment of sex hormone-dependent diseases such as advanced prostate cancer and uterine fibroids, the advent of gonadotropin-releasing hormone (GnRH) receptor antagonists has brought better medication options for patients. Relugolix, as an oral non-peptide GnRH receptor antagonist, can competitively block GnRH receptors in the anterior pituitary gland, reduce the secretion of luteinizing hormone and follicle-stimulating hormone, and thereby lower the production levels of testosterone in males and estrogen and progesterone in females, without experiencing the "flare-up effect" of initial hormone surge as required by traditional agonist drugs. At present, it has been approved for the treatment of adult patients with advanced prostate cancer, and has also been approved for female patients with moderate to severe symptoms related to uterine fibroids in some regions, providing an oral alternative for patients who are unwilling or unable to receive injection administration.

The global market size related to relugolix had exceeded 1.2 billion US dollars in 2023. With the expansion of indications in fields such as endometriosis, it is expected that the compound annual growth rate will remain at around 18% by 2028. The current market is still dominated by the original research product, and the layout of generic drugs is concentrated in China and India. More than 30 enterprises in China have submitted marketing applications for generic relugolix preparations. With the advancement of the centralized procurement policy, the market demand for API will be further released. If there is no verifiable data, please indicate it directly.

The original research enterprise of relugolix is Takeda Pharmaceutical Company Limited, Japan, with the original research trade name Relumina. The core compound patent will expire in 2033 in major markets such as China and the United States. At present, the main dosage form approved for the original research product is tablet, with two specifications of 120mg and 40mg, which has been included in the FDA Reference Listed Drug Catalog. China NMPA approved the import and marketing of the original research relugolix tablets in 2022. In terms of API registration, as of now, 3 domestic enterprises have submitted registration numbers for relugolix API on the CDE platform, all of which are in the status of "A" (approved for use in marketed preparations), and the registration applications of more than 10 other enterprises are under review. (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 relugolix API, which can perfectly meet the compliance requirements of all stages of drug development and quality research. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and help enterprises quickly advance the whole process of R&D declaration, production and quality control.