Emodepside

Acute ischemic stroke is one of the cerebrovascular diseases with the highest disability and mortality rates worldwide. Clinical thrombolytic therapy often faces a treatment gap of reperfusion injury after administration, and the advent of edaravone dexborneol provides a new solution to this clinical difficulty. As a new type of neuroprotective drug belonging to the free radical scavenger category, it can scavenge excess reactive oxygen free radicals generated during the ischemia-reperfusion process, inhibit lipid peroxidation, and reduce oxidative damage to neurons, thereby reducing cerebral edema and the volume of cerebral tissue infarction. At present, it is mainly used to improve the early neurological symptoms and daily activity disorders of patients with acute ischemic stroke after onset, and the applicable population is adult patients with acute ischemic stroke within 72 hours of onset.

Currently, the global market size of neuroprotective drugs for acute ischemic stroke has exceeded 12 billion US dollars, with a compound annual growth rate maintained at around 8.7%. As one of the few innovative drugs with clear mechanisms in this field in the past decade, the market penetration rate of edaravone dexborneol is increasing rapidly. In terms of the domestic market, only the original research enterprise has obtained marketing approval for this variety at present, and no generic drugs have entered the market. Coupled with the clinical demand driven by the continuous rise in the prevalence of stroke, the market incremental space is expected to exceed 2 billion yuan in the next 3 to 5 years, making it a potential variety attracting high attention in the fields of API and generic drug development.

The original research enterprise of edaravone dexborneol is Mitsubishi Tanabe Pharma of Japan, and the original research trade name is Radicava®. The core compound patent of edaravone dexborneol expires in 2032 in the United States, and the core compound patent in China expires in 2031. The main dosage form approved by the original research is injection, with a specification of 100ml:30mg, and its reference preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of the NMPA. Up to now, no domestic edaravone dexborneol API has been approved for registration in China, only the imported injection dosage form of the original research has been approved for marketing, and no domestic generic drug preparation has been approved. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for edaravone dexborneol, which fully meets the reference standard requirements of the whole process of API and preparation R&D and quality research. Most products on the platform are in stock, and spot orders placed before 16:00 can be shipped on the same day. All impurity reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, which can effectively help enterprises shorten the R&D cycle and reduce compliance risks.