Vazegepant

As a common neurovascular disease, migraine has a global prevalence rate of more than 12%, and the acute phase treatment has long been plagued by the pain points of slow onset and frequent side effects. Zavegepant belongs to a new generation of oral calcitonin gene-related peptide (CGRP) receptor antagonists. It can rapidly relieve migraine attacks without activating 5-hydroxytryptamine receptors by highly selectively blocking the binding of CGRP to its receptors, inhibiting neurogenic inflammation and intracranial vasodilation. This drug is approved for the acute treatment of migraine with or without aura in adults, as well as the preventive treatment of episodic migraine. It is particularly suitable for migraine patients who are intolerant to triptans or have underlying cardiovascular diseases, and it removes the contraindication limitations of traditional acute phase medications.

At present, the global market size of acute migraine treatment has exceeded 6 billion US dollars. With a lower adverse reaction rate, CGRP receptor antagonists maintain a compound annual growth rate of more than 27%, making them the fastest growing segment. As the world's first oral CGRP antagonist approved for both acute treatment and preventive treatment indications, zavegepant quickly occupied nearly 18% of the market share of drugs with the same target after its launch. At present, no generic drug of this variety has been approved in China, and only a small number of original research products have been approved for import through the urgently needed clinical channel, leading to an obvious gap in market supply.

The original research enterprise of zavegepant is Biohaven Pharmaceuticals, and the original trade name is Nurtec ODT. Its core compound patent in the United States will expire in 2039, and the crystal form patent will expire in 2041. The main dosage form of the original research product is orally disintegrating tablet with a specification of 75mg, which has been included in the FDA Reference Listed Drug Catalog. In China, the original research orally disintegrating tablet was approved for import in 2024. At present, no enterprise has submitted a drug master file application for zavegepant on the CDE API registration platform, and no generic drug preparation has 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 zavegepant impurity reference standards. The products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most of them are available in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day, providing stable and reliable reference standard support for the qualitative and quantitative analysis of impurities in the stages of drug development, quality research and generic drug declaration.