Etrasimod

Ulcerative colitis, as a chronic idiopathic intestinal inflammatory disease, has long been plagued by clinical treatment pain points of high recurrence rate and frequent adverse reactions of traditional drugs. The launch of etrasimod provides patients with such conditions a safer option for long-term maintenance therapy. As a new generation of oral sphingosine-1-phosphate (S1P) receptor modulator, it can selectively bind to S1P1 receptors, prevent lymphocytes from migrating out of lymph nodes, and reduce inflammatory infiltration in the intestinal mucosa, while avoiding the cardiotoxicity risk caused by non-selective S1P receptor modulators. At present, its approved indication is mild to moderate active ulcerative colitis in adults, and it has been listed as a second-line recommended drug for mild to moderate ulcerative colitis in a number of clinical guidelines, especially suitable for patients with insufficient response or intolerance to traditional aminosalicylic acid drugs.

The global number of patients with ulcerative colitis exceeds 12 million, driving the continuous expansion of the S1P receptor modulator market. As the first oral small molecule drug targeting this indication for ulcerative colitis, etrasimod's global sales in 2023 have exceeded 900 million US dollars, with an annual growth rate of more than 65%. At present, only the original research manufacturer has realized the large-scale supply of this API worldwide, and no generic drug has been approved in China. With the gradual release of domestic patients' medication demand, there is still a large room for improvement in its market penetration rate.

The original research manufacturer of etrasimod is Takeda Pharmaceutical of Japan, with the trade name RIZMOD® (瑞莫迪®), and its core compound patent will expire in China in 2032. The currently approved and marketed dosage form is oral tablet, with three specifications of 0.5mg, 1mg and 2mg, which has been included in the FDA Reference Listed Drug Catalog, and the imported preparation has also been approved for marketing in China. Up to now, there is no etrasimod API approved for marketing in China, and no relevant API registration information in A status has been found. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of etrasimod impurity reference standards, which meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most of the products are available from stock, and orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable reference standard support for qualitative and quantitative analysis of impurities in the stages of drug development and quality research.