麦角胺

Migraine is a recurrent neurovascular disease with more than 1 billion patients worldwide. Symptoms such as nausea and photophobia accompanying severe headache in the acute phase seriously affect the quality of life of patients. Ergotamine is an ergot alkaloid drug. By agonizing 5-hydroxytryptamine 1B/1D receptors and exerting weak agonistic effects on α-adrenergic receptors and dopamine receptors, it can constrict the dilated intracranial blood vessels and inhibit the pain signal conduction of the trigeminal nerve, thereby relieving the symptoms of acute migraine attacks. Clinically, it is mainly used for the treatment of acute migraine without obvious contraindications, especially suitable for the patient group with poor response to non-steroidal anti-inflammatory drugs.

At present, the global market size of acute migraine treatment drugs has exceeded 6 billion US dollars. As a classic treatment drug, although ergotamine has lost part of its market share to triptans, it still maintains a stable market demand by virtue of its price advantage and clinical value in refractory migraine. In the domestic market, ergotamine preparations are commonly used low-price clinical drugs, the suppliers are mainly domestic generic drug enterprises, the concentration of the raw material supply end has been high for a long time, and the annual growth rate of the overall market size remains in the range of 3% to 5%.

The original research enterprise of ergotamine is Novartis, and the original research brand name is Cafergot (compound preparation with caffeine). Its core compound patent expired worldwide before 1990. At present, the main dosage form of the original research product on the market is tablet, which is a compound preparation with the specification of 1mg ergotamine and 100mg caffeine, and this compound preparation has been included in the FDA Reference Listed Drug Catalog. In terms of the domestic market, there are no approved imported ergotamine-related preparations, and only ergotamine and caffeine tablets have been approved for marketing among domestic preparations; the API registration platform shows that no valid and listed ergotamine API registration number has been found so far. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of ergotamine impurity reference standards, which fully meet the needs of qualitative and quantitative impurity analysis, quality research and registration declaration in the process of API production. Most products are available in stock, and in-stock products ordered before 16:00 can be delivered on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can effectively help enterprises reduce quality research costs and accelerate the declaration progress.