Lasmiditan

Migraine is a highly prevalent neurological disease worldwide. The pain during acute attacks, accompanied by symptoms such as nausea and photophobia, severely affects the quality of life of patients. Triptan drugs used to be limited in clinical application scenarios due to the contraindication of vasoconstriction. Lasmiditan is a highly selective 5-hydroxytryptamine 1F receptor agonist. By binding to 5-HT1F receptors in the trigeminal pathway, it inhibits neuropeptide release and inflammatory response, and can relieve acute migraine attacks without vasoconstriction. It is not only suitable for the acute treatment of migraine with or without aura in adults, but also provides a safer medication option for migraine patients with cardiovascular risks such as hypertension and coronary heart disease.

At present, the global market size of acute migraine treatment drugs has exceeded 6 billion US dollars. As the first innovative ditan drug launched on the market, lasmiditan has maintained a market growth rate of more than 35% after its launch. The domestic patient base of migraine exceeds 130 million. In the past, acute treatment drugs were mainly non-steroidal anti-inflammatory drugs and generic triptans, and there is a significant gap in the clinical demand for new highly selective drugs. With the acceleration of generic drug research and development progress, the market size of its API is expected to exceed 200 million yuan in the next 3 years. At present, the API supply side is still dominated by supporting enterprises of the original research drug. Nearly 10 domestic enterprises have submitted marketing applications for generic lasmiditan, and the API supply gap is gradually being released.

The original research enterprise of lasmiditan is Eli Lilly and Company in the United States, and the original brand name is Reyvow. Its core compound patent in the United States expires in 2031, and the compound patent in China expires in 2030. The main dosage form approved for the original research drug is oral tablet, with specifications of 50mg and 100mg. The original tablets have been included in the FDA Reference Listed Drug Catalog, but have not yet been included in the Chinese Reference Listed Drug Catalog. At present, many domestic enterprises have submitted DMF registrations for lasmiditan API. No original research preparation has been approved for import, and 3 domestic enterprises have obtained marketing approval for lasmiditan tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of lasmiditan impurity reference standards. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in the stages of API research and development, quality research and registration application.