Ibudilast

As a small-molecule phosphodiesterase inhibitor with both anti-inflammatory and neuroprotective effects, ibudilast selectively inhibits the activity of PDE4 to reduce the release of inflammatory factors, while it can block the excessive activation of microglia and improve cerebral microcirculation. Clinically, it is mainly used to relieve symptoms such as dizziness and headache caused by bronchial asthma, sequelae of cerebral infarction, etc., and has unique clinical value in the cross-treatment field of neurodegenerative diseases and respiratory system diseases.

At present, the global market size of ibudilast is approximately USD 320 million, with a compound annual growth rate of 7.8% in the past three years. The growth is mainly driven by the clinical expansion of indications for rare diseases such as amyotrophic lateral sclerosis and multiple sclerosis. In terms of the domestic market, with the continuous rise in the prevalence of cerebrovascular diseases, the terminal medication scale of ibudilast has exceeded RMB 300 million. There are less than 5 generic drug manufacturers, the variety has not been covered by centralized procurement, and the supply pattern of API is relatively concentrated.

The original research enterprise of ibudilast is Kyorin Pharmaceutical Co., Ltd. of Japan, with the trade name "Ketan". The core compound patent expired in 2011 in major markets such as Japan and the United States, and expired in 2009 in China. The original dosage form marketed in China is sustained-release capsules, with a specification of 10 mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, there have been 7 registration entries of ibudilast on the CDE API registration platform, among which 5 are in Status A, and the ibudilast sustained-release capsules of multiple domestic enterprises have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for ibudilast, covering the whole chain of starting materials, intermediates and degradation impurities. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All products comply with the pharmacopeia of China, FDA and other pharmaceutical regulatory regulations of various countries, and can fully meet the reference standard requirements throughout the whole cycle of drug R&D, quality research and production release.