Insomnia, characterised by difficulties in sleep onset and/or sleep maintenance, is highly prevalent in Japan, affecting about 20% of Japanese adults according to the MHLW, and is recognized as an important national issue impacting both physical and mental health.

The approval of QUVIVIQ by the MHLW is supported by positive results of a randomised, double-blind, placebo-controlled Phase 3 study in Japan to investigate the efficacy and safety of daridorexant. The study met all primary and secondary efficacy endpoints. 

QUVIVIQ (daridorexant) is a dual orexin receptor antagonist that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and a New Drug Application was submitted in Japan in October 2023. Daridorexant is approved in the US and Europe and marketed in these territories under the brand name QUVIVIQ by Idorsia Pharmaceuticals.

Nxera Pharma has the Japanese and APAC (ex-China) rights for daridorexant following its acquisition of Idorsia Pharmaceuticals Japan Ltd and Idorsia Pharmaceuticals Korea Co., Ltd in 2023. QUVIVIQ was co-developed in Japan by NPJ and Mochida Pharmaceutical Co.