Cilostazol

Peripheral arterial disease is a common vascular degenerative disease among middle-aged and elderly people. Patients often experience symptoms such as intermittent claudication and pain, which seriously affect their quality of life. As a selective phosphodiesterase Ⅲ inhibitor, cilostazol exerts its effects by inhibiting platelet aggregation and dilating blood vessels. It can not only improve peripheral arterial blood perfusion and relieve symptoms of intermittent claudication, but also be used to prevent the recurrence of cerebral infarction. It is currently one of the core drugs in the field of peripheral vascular disease treatment, and its applicable population includes peripheral arterial disease patients without a history of heart failure and people for secondary prevention of non-cardioembolic ischemic stroke.

The global cilostazol market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 480 million, of which the Chinese market accounted for 32%. Due to the early expiration of patents, generic drugs dominate the market. There are nearly 30 marketing authorizations for cilostazol preparations in China. In the 2022 provincial-level centralized drug procurement, the average price reduction of this variety reached 58%, and the accessibility at the primary level has been greatly improved, driving the annual growth rate of API demand to maintain at around 7%. Domestic manufacturers are concentrated in Jiangsu, Zhejiang and other regions, and the production capacity of leading enterprises accounts for more than 60%.

The original developer of cilostazol is Otsuka Pharmaceutical of Japan, with the brand name Pletaal. The core compound patents have all expired in major markets. The US patent expired in 2007, and the Chinese compound patent expired in 2003. The dosage forms of the original marketed products include 50mg and 100mg tablets, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA Reference Preparation Catalogue. Up to now, there are more than 20 cilostazol registration numbers on the API registration platform of China CDE, most of which are in A status. A variety of dosage forms such as tablets and capsules have been approved for marketing in China. (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 cilostazol API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can effectively support pharmaceutical enterprises in API quality research, consistency evaluation and registration declaration, and efficiently meet the reference standard needs of the whole process of drug R&D and production.