Istradefylline

As a common neurodegenerative disease, Parkinson's disease is seeing a continuously rising clinical demand for treatments to improve motor complications amid the accelerating global population aging process. Istradefylline is an adenosine A2A receptor antagonist. By selectively blocking adenosine A2A receptors in the striatum, it regulates dopaminergic nerve conduction and γ-aminobutyric acid release, can significantly prolong the "on-time" and shorten the "off-time" without increasing the dosage of levodopa, and meanwhile reduces the risk of dyskinesia. It is mainly used for adult Parkinson's disease patients receiving levodopa-based therapy, and is currently one of the first-choice adjuvant drugs for motor complications recommended by domestic and foreign guidelines.

At present, the global market size of istradefylline has exceeded 300 million US dollars, with a compound annual growth rate maintained at around 7.2%. The core growth drivers come from the rising prevalence of Parkinson's disease and the improved clinical awareness of motor complication management. The domestic market is still in the rapid introduction stage. Due to the relatively recent expiration of the original research patent, there are currently a small number of enterprises engaged in generic drug development and layout, and the market concentration is relatively high. With the subsequent approval and launch of generic drugs and the advancement of medical insurance negotiations, it is expected that the compound annual growth rate of the domestic market size will exceed 18% in the next 3 years, presenting a large market increment space.

The original research enterprise of istradefylline is Kyowa Kirin Co., Ltd. of Japan, with the original research brand name "No URIA". Its core compound patent will expire in China in 2024. The main dosage form approved for the original research product is tablet, with a specification of 20mg. 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. Up to now, 3 domestic enterprises have had their istradefylline API pass the pre-marketing review and publicity of CDE and obtained Class A registration numbers. The original research istradefylline tablets and those from 2 domestic enterprises have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for istradefylline API, fully covering impurities generated in the synthesis process, degradation impurities and specific isomers. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are available in stock, and in-stock orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process needs of pharmaceutical enterprises in R&D, quality research and routine production inspection.