Elagolix

Endometriosis is a chronic painful disease with high incidence among women of childbearing age. For a long time, clinical treatment has been dominated by hormonal drugs, which have the pain points of obvious adverse reactions and poor tolerance in long-term use. Elagolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It competitively blocks pituitary GnRH receptors, inhibits gonadotropin secretion in a dose-dependent manner, and then reduces ovarian estrogen levels. It is the first oral targeted therapeutic drug for moderate to severe pain in endometriosis. In addition to improving dysmenorrhea and non-menstrual pelvic pain related to endometriosis, its low-dose regimen can also be used for the treatment of moderate to severe menstrual bleeding related to uterine fibroids, providing a new option for women of childbearing age who cannot tolerate traditional hormone therapy.

The global market size related to elagolix has exceeded US$900 million in 2023. Driven by the increase in the consultation rate of endometriosis and uterine fibroids among women of childbearing age and the rising recognition of oral targeted treatment regimens in clinical practice, the compound annual growth rate is expected to remain at around 8.2% from 2025 to 2030. At present, the original research products occupy an absolute dominant position in the global market, and the Chinese market is still in the introduction period. Only the original research preparation has been approved for marketing, and no domestic generic drug has been approved. With the update and promotion of relevant domestic treatment guidelines, there is considerable space for domestic generic drugs in the future. There is no publicly verifiable information on the main production area and centralized procurement implementation records for relevant data.

The original research enterprise of elagolix is AbbVie, and the original research trade name is Orilissa. Its core compound patent in the United States will expire in 2026, and the compound patent in China will expire in 2027. The main dosage form approved by the original research is tablet, with specifications including 150mg and 200mg. The 200mg specification has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Chinese Catalog of Reference Preparations for Chemical Drugs. As of now, there is no domestic elagolix preparation approved for marketing in China, and there is no public valid API registration number on the CDE API registration platform. (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 elagolix API. All series of products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most impurities have sufficient spot inventory. Spot products ordered before 16:00 can be delivered on the same day, which can fully meet the supply needs of pharmaceutical enterprises in all stages of generic drug research and development, consistency evaluation and quality control.