Balsalazide

As a recurrent chronic digestive tract disease, inflammatory bowel disease has long led the clinical field to constantly pursue treatment regimens with better efficacy and lower adverse reactions. The advent of balsalazide provides a more precise option for the maintenance treatment of mild to moderate ulcerative colitis. As a 5-aminosalicylic acid prodrug, it is only decomposed by bacterial enzymes in the colon to release the active ingredient after oral administration, which not only avoids the adverse reactions caused by absorption in the upper digestive tract, but also maintains a high drug concentration at the lesion site. At present, it has been recommended by domestic and foreign guidelines for the induction of remission of mild to moderate active ulcerative colitis in adults and children over 5 years old, as well as for the long-term maintenance treatment of ulcerative colitis in adults, and is a commonly used intestinal anti-inflammatory API in the digestive field.

At present, the global balsalazide market size is stable at around USD 320 million, with a compound annual growth rate of 4.7%. The growth momentum mainly comes from the continuous rise in the prevalence of inflammatory bowel disease and the increasing clinical demand for low-toxicity anti-inflammatory drugs. In terms of the domestic market, the currently approved balsalazide preparations are mainly generic drugs. After the coverage of centralized procurement, the terminal price has dropped by more than 60%, and the overall market volume has increased significantly. The supply demand for upstream APIs has increased by 124% compared with that in 2019. The competitive landscape is relatively concentrated, with the top 3 API enterprises accounting for nearly 85% of the domestic supply share.

The original research enterprise of balsalazide is Tillotts Pharma, with the original research brand name "Colazal". Its core compound patent in the United States expired in 2010, and its core preparation patent in China expired in 2014. The main dosage form approved for the original research product is capsules, with a specification of 750mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. At present in China, 6 enterprises have obtained A status for their balsalazide APIs through CDE registration, and another 11 balsalazide preparations (including tablets, capsules and granules) have been approved for marketing, covering all clinically commonly used dosage forms. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of balsalazide API, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA at the same time, and can provide reliable reference standard support for pharmaceutical enterprises in impurity research, stability investigation and quality standard establishment.