Cinnarizine

Cerebrovascular diseases, as chronic diseases with high incidence in the middle-aged and elderly population, have long ranked among the top in the global disease burden. Calcium channel blockers are one of the core categories of drugs clinically used to improve cerebral circulation. Cinnarizine is a piperazine calcium antagonist. It dilates blood vessels by blocking calcium influx into vascular smooth muscle, and significantly improves cerebral circulation and coronary circulation. It has particularly high selectivity for cerebral blood vessels, and can relieve vasospasm and prevent migraine attacks. Clinically, it is mainly used for the treatment of cerebral thrombosis, cerebral embolism, cerebral arteriosclerosis, recovery period of cerebral hemorrhage, recovery period of subarachnoid hemorrhage, sequelae of brain trauma, as well as inner ear vertigo and diseases related to poor peripheral circulation. The applicable population covers patients in the recovery period of cerebrovascular diseases, patients with frequent chronic migraine attacks and people with vestibular dysfunction.

From the perspective of the global market, the stable demand for cerebrovascular chronic disease drugs supports the cinnarizine market to maintain a steady growth trend. In 2023, the global market size was approximately USD 180 million, with a compound annual growth rate maintained at around 2.1%. For the domestic market, oral preparations have been included in the Category B of the National Medical Insurance Catalogue, and the demand from primary medical institutions accounts for more than 40%. At present, the production side is dominated by generic drugs. There are a total of 32 approved domestic cinnarizine preparation approvals. The supply of APIs presents a pattern dominated by local enterprises and supplemented by imports. It has not yet been included in the scope of national centralized volume-based procurement, and the market competition is relatively mild.

The original developer of cinnarizine is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and the original brand name is Sibelium. The core compound patent expired globally in 1990. At present, the mainstream dosage form is tablet, with conventional specifications of 5mg and 25mg. The original tablet has been included in the FDA Reference Listed Drug Catalogue and the *Catalogue of Reference Preparations for Chemical Drugs* of China. With regard to domestic API registration, as of now, there are 8 cinnarizine registration numbers with A status on the CDE API registration platform, all of which are declared by local enterprises. The domestically approved cinnarizine preparations on the market include two dosage forms: tablets and capsules. (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 cinnarizine API. Most products are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of enterprises in the whole process of R&D, quality research and production.