Upacicalcet Sodium

There have long been unmet clinical needs in the treatment of chronic kidney disease-related hyperparathyroidism, especially for the population of dialysis patients with hyperphosphatemia combined with hyperparathyroidism. As an innovative calcimimetic active pharmaceutical ingredient, upacacerse sodium allosterically modulates the calcium-sensing receptor to enhance the receptor's sensitivity to extracellular calcium ions, and inhibits the synthesis and secretion of parathyroid hormone without increasing serum calcium and phosphorus levels. It is mainly used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and can also be combined with other therapies to control hypercalcemia in patients with parathyroid carcinoma, providing a new medication option for long-term dialysis populations to reduce the risk of cardiovascular complications.

The current global market size of drugs for secondary hyperparathyroidism has exceeded 5 billion US dollars, with a compound annual growth rate of 7.2% in the past three years. Among them, calcimimetic drugs account for more than 40%, making them the fastest-growing sub-category in this field. The number of domestic dialysis patients has exceeded 900,000, and the clinical demand for upacacerse sodium-related preparations continues to rise. At present, the domestic supply of this active pharmaceutical ingredient is still dominated by the original imported products and a small number of compliant generic pharmaceutical companies. With the acceleration of generic drug research and development, the market gap is gradually being released.

The original research enterprise of upacacerse sodium is Amgen, and the original brand names are Sensipar / 盖平. The core compound patent expires in 2028 in the United States and in 2026 in China. The main marketed dosage form of the original product is tablet, with specifications including 30mg, 60mg and 90mg. This product has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, multiple domestic enterprises have submitted the API registration applications for upacacerse sodium on the CDE API Registration Platform, some of which are in Status A, and multiple domestic pharmaceutical companies have been approved to produce upacacerse sodium tablets. (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 upacacerse sodium, which can meet enterprises' needs for impurity reference standards throughout the whole process from API process development to quality research and registration application. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia and the FDA, and complete structure confirmation and quality control data can be provided simultaneously, helping enterprises shorten the research and development cycle.