Retigabine

For patients with drug-resistant focal epilepsy, the limitations of existing treatment regimens have long restricted the improvement of clinical efficacy. As the first antiepileptic drug of the neuronal potassium channel opener class, retigabine selectively activates the neuronal Kv7.2/7.3 potassium ion channel, promotes potassium ion efflux to stabilize the resting membrane potential of neurons, and reduces abnormal high-frequency discharges. Clinically, it is mainly used as adjuvant therapy for refractory focal epileptic seizures in adults, and can provide a new treatment option for patients with poor response to conventional antiepileptic drugs.

The global market size of antiepileptic drugs has exceeded 27 billion US dollars, among which the compound annual growth rate of the drug-resistant epilepsy-related细分赛道 remains around 6%. Due to its unique mechanism of action, retigabine occupies a fixed share in the refractory epilepsy drug market. At present, the dosage forms launched globally are mainly oral tablets, the layout of overseas generic drug manufacturers is relatively limited, and a large-scale generic competition pattern has not yet been formed in China, so the relevant clinical demand has not been fully met. (If accurate market data is needed, it is recommended to refer to public industry reports.)

The original research enterprise of retigabine is GlaxoSmithKline, and the original research brand name is Potiga. The core compound patent in the United States expired in 2013, and the core patent in Europe expired in 2014. The dosage form approved for the original research is oral tablets, with specifications including 50mg, 200mg, 300mg and 400mg, and the original research preparation has been included in the FDA Reference Listed Drug Catalog. Up to now, no retigabine preparation has been approved for marketing in China, and there is no valid retigabine API registration information on the CDE API registration platform. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for retigabine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for drug R&D, quality research and other links.