Nicergoline

In response to the clinical needs for cognitive decline caused by cerebrovascular disorders and peripheral circulatory disorders, nicergoline, a semi-synthetic ergot derivative, has become a commonly used treatment option in relevant fields. It dilates blood vessels by blocking α-adrenergic receptors, while inhibiting phosphodiesterase activity, promoting energy metabolism of brain cells and the conversion of the neurotransmitter dopamine. It can effectively improve hypowill and affective disorders caused by sequelae of cerebral infarction, and can also be used for acute and chronic peripheral circulatory disorders, especially meeting the long-term intervention needs of middle-aged and elderly patients with cerebrovascular diseases and people with peripheral vascular diseases.

At present, the global market size of nicergoline is stable at around USD 1.2 billion, and the annual growth rate of the Chinese market remains at around 7%. With the acceleration of the domestic aging process, the prevalence of cerebrovascular diseases continues to rise, and there is still considerable room for the release of clinical demand. The domestic preparation market has formed a pattern of coexistence of original research drugs and generic drugs. More than 20 enterprises have obtained approval for marketing of their generic drugs, among which oral dosage forms have been included in the seventh batch of national centralized drug procurement, with an average price reduction of over 70% for the selected products, which further reduces the medication burden of patients and also drives the continuous rise of demand for upstream API.

The original research enterprise of nicergoline is Pfizer, and the original research brand name is "Sermion". Its core compound patent expired globally in 2009. At present, the dosage forms of the original research drug approved in China include tablets and injections. The specification of the tablets is 10mg, and the specification of the injections is 4mg. Both dosage forms have been included in the Catalogue of Marketed Drugs in China as reference preparations. In terms of API registration, as of now, there are more than 30 nicergoline registration entries on the CDE API registration platform, among which the registration status of multiple enterprises is "A", which can meet the associated review requirements for domestic preparation production. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of nicergoline impurity reference standards. Most products 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 regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for the whole process of drug research and development, quality research and production quality control.