Nalfurafine

Chronic kidney disease-associated pruritus is a highly prevalent complication in patients on maintenance dialysis, with an incidence rate exceeding 60% and a response rate to conventional antihistamines of less than 30%. The advent of nalfurafine has filled this clinical gap. As a highly selective κ-opioid receptor agonist, it binds to κ-opioid receptors in the central and peripheral nervous systems to inhibit the transmission of pruritus signals, while avoiding the risks of addiction and respiratory depression associated with traditional μ-opioid receptor agonists. It is mainly used to improve refractory pruritus symptoms in patients undergoing hemodialysis and peritoneal dialysis, and is currently the preferred second-line or higher treatment option for pruritus recommended by multiple international guidelines.

The global market size of nalfurafine was approximately USD 210 million in 2023, with a compound annual growth rate of 11.2% from 2019 to 2023. The core growth drivers are the continuous expansion of the global dialysis patient base and the release of unmet clinical needs for refractory pruritus. The Chinese market is currently in a rapid introduction phase. After the preparation was approved for marketing in 2021, its sales scale has been increasing year by year. The current competitive landscape is relatively concentrated, with the original research product dominating, and only a small number of domestic enterprises have laid out generic drug research and development, resulting in an obvious supply gap for active pharmaceutical ingredients.

The original research enterprise of nalfurafine is Toray Industries, Inc. of Japan, with the original brand name "Remitch". Its core compound patent expires in 2024 in Japan and in 2022 in China. The main dosage form approved for the original research product is orally disintegrating tablet, with specifications including 2.5μg and 5μg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration of China. Up to now, there is no marketing registration information of nalfurafine active pharmaceutical ingredients submitted by domestic or foreign enterprises on the platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and the only preparation approved for marketing in China is the orally disintegrating tablet imported from the original research manufacturer. (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 nalfurafine API, which can cover the needs of all research scenarios such as process impurities and degradation impurities. Most products are available from stock. Orders for in-stock products 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 effectively support impurity research and application document preparation in the research and development stage.