Ticlopidine

Cardiovascular and cerebrovascular diseases are the disease category with the highest fatality rate globally, and antiplatelet therapy is the core strategy for the prevention and treatment of thromboembolic diseases. Ticlopidine is a thienopyridine ADP receptor antagonist, which irreversibly inhibits the P2Y12 receptor on the platelet membrane, blocks the ADP-mediated platelet aggregation and activation pathway, and reduces the risk of thrombosis. Clinically, it is mainly used to prevent the recurrence of stroke, myocardial infarction and peripheral arterial thrombotic diseases, especially suitable for high-risk populations with ischemic events who are intolerant or allergic to aspirin, and is a classic alternative drug in the field of antiplatelet therapy.

At present, the global antiplatelet drug market size exceeds 20 billion US dollars. As an early launched thienopyridine drug, although ticlopidine is squeezed by new generation products such as clopidogrel and ticagrelor, it still maintains stable demand in the primary care market and low- and middle-income countries, with an annual market size of approximately 320 million US dollars. In the domestic market, ticlopidine preparations have been included in the Class B Medical Insurance Catalog. There are currently 12 preparation approvals, with manufacturers mainly dominated by local generic pharmaceutical companies, and the competition landscape is fragmented. The demand for active pharmaceutical ingredients (APIs) is showing a steady upward trend along with the expansion of the coverage of primary thrombosis prevention and treatment drugs.

The original developer of ticlopidine is Sanofi, France, with the original brand name "Ticlid". Its core compound patent expired globally in 1999. The originally approved dosage form is mainly 250mg tablets, which have been included in the FDA Reference Listed Drug Catalog and the *Catalogue of Reference Preparations for Chemical Drugs (Second Batch)* of China. According to the domestic API registration platform, there are currently 6 valid registration numbers (status A) for ticlopidine APIs, all of which can be associated with preparation declarations. The domestically approved ticlopidine preparations include tablets and capsules, with a total of 12 marketing approvals, which can meet the demand for routine clinical use. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of ticlopidine impurity reference standards. All products meet the requirements of relevant regulations of the Chinese Pharmacopoeia and the FDA. Most impurities are in sufficient stock, and orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for pharmaceutical companies in API R&D, quality research and consistency evaluation work.