Zolmitriptan

Migraine is a common neurovascular disease with a global prevalence of over 10%. The pulsating headache, nausea, photophobia and other symptoms accompanying its attacks severely affect patients' daily work and life. Zolmitriptan is a second-generation selective 5-hydroxytryptamine 1B/1D receptor agonist. By acting on relevant receptors on intracranial blood vessels and sympathetic nerves of the trigeminal nervous system, it inhibits the release of neuropeptides, constricts abnormally dilated cerebral blood vessels, and blocks the transmission of pain signals. It is currently a first-line drug for the treatment of acute attacks of migraine with or without aura in adults. It can relieve headache and accompanying symptoms in a short time, and significantly reduce the impact of migraine on patients' quality of life.

At present, the global zolmitriptan market size maintains a steady growth trend. In 2023, the overall market size was close to USD 400 million, of which generic drugs accounted for more than 75%. In terms of the domestic market, with the improvement of migraine diagnosis and treatment rate and the advancement of centralized drug procurement policies, the compound annual growth rate in the past three years has reached 9.2%. In 2023, the sales of zolmitriptan in domestic sample hospitals exceeded RMB 120 million. At present, there are more than 20 domestic manufacturers of zolmitriptan preparations that have obtained approval. The average winning bid price in provinces that have completed centralized procurement has dropped by 68% compared with the original research drug price. The domestic substitution process continues to accelerate, and the demand for upstream API has also shifted to the local supply chain.

The original research enterprise of zolmitriptan is AstraZeneca, with the original brand name "Zomig". Its core compound patents expired in 2012 and 2013 in the European and US markets respectively, and the Chinese compound patent expired in 2014. The main dosage forms approved for the original research product include tablets and nasal sprays, with conventional specifications of 2.5mg and 5mg. The original research product has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are 17 registration records of zolmitriptan API on the API registration platform of China Center for Drug Evaluation (CDE), among which 14 are domestic registrations, and 3 are in status A (approved for use in marketed preparations). The zolmitriptan preparations that have been approved for marketing in China cover multiple dosage forms such as tablets, dispersible tablets and nasal sprays. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of zolmitriptan impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of pharmaceutical enterprises in different stages such as API and preparation R&D, quality control, and registration declaration.