Perampanel

Among the approximately 70 million epilepsy patients worldwide, nearly 30% face the treatment dilemma that existing drugs cannot control their seizures. The advent of perampanel provides a brand-new treatment option for this population. As a highly selective, non-competitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist, it targets the activity of glutamate AMPA receptors on the postsynaptic membrane to inhibit excessive neuronal excitation, and is currently the only AMPA receptor class drug approved for epilepsy in the world. It can be clinically used as monotherapy or adjunctive therapy for partial-onset seizures (with or without secondary generalized seizures) in epilepsy patients aged 4 years and older, as well as primary generalized tonic-clonic seizures in patients aged 12 years and older. It has good long-term medication safety and little impact on cognitive function, which is particularly suitable for the treatment needs of children and adolescent patients.

In recent years, the global market size of antiepileptic drugs has exceeded 20 billion US dollars. Among them, the peak annual sales of perampanel exceed 1.6 billion US dollars, accounting for about 12% of the market share of third-generation antiepileptic drugs. The growth rate of the Chinese market is even more significant, with a compound growth rate of more than 42% in the past three years. At present, more than 20 enterprises have laid out the generic drug track. After the implementation of centralized procurement, the price has dropped by more than 80%, the accessibility for patients has been greatly improved, and the demand for upstream API has entered a period of rapid growth accordingly.

The original research enterprise of perampanel is Eisai Co., Ltd., and the original research trade name is "Fycompa". The core compound patent of perampanel will expire in the United States and Europe in 2026, and the Chinese compound patent has expired early due to partial patent challenges. The dosage forms approved by the original research include tablets and oral suspensions, with specifications covering 2mg, 4mg, 6mg, 8mg, 10mg and 12mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, nearly 15 Chinese enterprises have obtained CDE registration numbers (status A) for perampanel APIs, and more than 10 enterprises have obtained marketing approval for their generic preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of perampanel impurity reference standards, most of which 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 compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in API synthesis process optimization, quality research and declaration work.