Falecalcitriol

Chronic kidney disease-related secondary hyperparathyroidism is a common complication in patients undergoing long-term dialysis, which can induce serious adverse prognoses such as bone metabolism disorders and vascular calcification. As a novel vitamin D receptor agonist, paricalcitol highly selectively activates vitamin D receptors, inhibits excessive secretion of parathyroid hormone, exerts less impact on blood calcium and blood phosphorus levels, and reduces the risk of hypercalcemia. It is mainly clinically used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and can also be partially used for adjuvant intervention of osteoporosis, significantly improving the long-term treatment tolerance of patients.

The global market size related to paricalcitol was approximately USD 280 million in 2023, with a compound annual growth rate of 6.2% in the past three years. The growth is mainly driven by the expansion of the end-stage renal disease dialysis population and the increase in the diagnosis and treatment rate of osteoporosis. In terms of the competitive landscape, the original research product accounts for nearly 75% of the global market share, and there are fewer than 5 domestic enterprises engaged in the development of generic drugs of this variety. Currently, this variety has not been included in the national centralized procurement list. With the gradual improvement of clinical recognition, there is still considerable penetration space in the domestic market of related preparations and active pharmaceutical ingredients.

The original research enterprise of paricalcitol is Chugai Pharmaceutical Co., Ltd. of Japan, with the original brand name "Oxarol". Its core compound patent will expire in 2028 in the United States, and the core compound patent in China will expire in 2027. The main dosage form approved for the original research product is oral capsule, with two specifications of 0.25μg and 0.5μg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, no domestic enterprise has obtained the marketing registration approval for paricalcitol active pharmaceutical ingredient, and no domestic preparation has been approved for marketing. Only the original research product obtained the import approval from the China NMPA in 2021. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of paricalcitol impurity reference standards, covering all impurity types that may occur during production and degradation processes. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of the whole process of active pharmaceutical ingredient research and development, quality research and registration application.