Cyclandelate

Cerebrovascular disease is a chronic disease with a high incidence in the middle-aged and elderly population. Symptoms such as vertigo and memory decline caused by insufficient blood supply to brain tissue affect the quality of life of patients for a long time, so there is an urgent clinical need for treatment options with both vasodilatory activity and medication safety. Cyclandelate is a peripheral vasodilator belonging to the calcium antagonist class, which can directly relax vascular smooth muscle and selectively dilate the blood vessels of the brain, kidney, limbs and coronary arteries, increasing local blood flow without increasing myocardial oxygen consumption. It is clinically used for the treatment of cerebral arteriosclerosis, post-traumatic brain sequelae, acroarteriospasm, acrocyanosis, obliterative endarteritis and other diseases, and has high applicability for elderly patients with vascular disease complicated by hyperlipidemia.

At present, the global market size of cyclandelate is approximately USD 230 million, with a compound annual growth rate of around 4.2% in the past three years. The growth drivers mainly come from the improvement of the coverage of primary-level cerebrovascular disease diagnosis and treatment and the expansion of the patient population with peripheral vascular disease. In terms of the domestic market, this variety is a mature drug, with generic enterprises accounting for more than 90%. It has been included in the local medical insurance catalogs of multiple provinces, the overall price system is stable, and the annual growth rate of API demand remains at about 5%. East China is the core domestic API production cluster area.

The original research enterprise of cyclandelate is Sanofi, France, with the original brand name "Cyclospasmol". Its core compound patent expired globally in 1989, and there is currently no valid core patent restriction. The main dosage form approved for the original product is capsule, with a specification of 100 mg per capsule, which has been included in the FDA Orange Book Reference Listed Drug Catalog, and the original preparation has not been imported into China for the time being. According to the domestic API registration platform, there are currently 7 enterprises that have obtained A-status registration numbers for cyclandelate APIs, and there are 32 domestic preparation approval documents, all of which are oral capsule dosage forms. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for cyclandelate API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of process R&D, quality research and declaration.