Eisai Submits NDA for Lemborexant, China's First OX1R/OX2R Antagonist for Insomnia

On January 11, the CDE website showed that Eisai's lemborexant tablets (lemborexant) had their marketing application accepted for the treatment of insomnia. This is the first OX1R/OX2R antagonist to be submitted for marketing in China.

Lemborexant, developed by Eisai, is an orexin receptor antagonist that binds to orexin receptors OX1R and OX2R (with IC50 values of 6.1 nM and 2.6 nM, respectively) and acts as a competitive antagonist. The orexin neuropeptide signaling system plays a role in wakefulness. By blocking the binding of the wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R, it suppresses wakefulness drivers. In patients with insomnia, the orexin signaling system that regulates wakefulness may not function properly.

Lemborexant (brand name: Dayvigo) was approved by the U.S. FDA for marketing in December 2019 for the treatment of insomnia in adults. In April 2020, the product was designated as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA). Individuals with a history of alcohol or drug abuse or addiction may have an increased risk of Dayvigo abuse and addiction, so careful follow-up is necessary. Additionally, lemborexant has also been approved in Japan for the indication of insomnia.

According to Eisai's financial report, the global sales of Leborex in 2022 were $241.4 million.

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