At a Glance
- Company: Nxera Pharma Co., Ltd. (TYO: 45650)
- Location: Tokyo, Japan (Nxera); South Korea (trial)
- Headline figure: Met primary/secondary endpoints; MAA Q1 2026, approval expected Q1 2027
- Focus area: Daridorexant (Quviviq), dual orexin receptor antagonist (DORA) for insomnia
- Next steps: Submit marketing authorisation application to South Korean MFDS
What happened?
Nxera Pharma reported positive topline results from a phase 3 trial of daridorexant 50mg in adult and elderly patients with insomnia conducted in South Korea. The multicentre, randomised, double‑blind, placebo‑controlled study met both primary and key secondary efficacy endpoints after 28 days of once‑daily dosing.
Why does it matter?
Insomnia affects 15–25% of South Korean adults (~6.5–11 million people), with significant physical/mental health impacts. Daridorexant, approved in Japan as Quviviq (launched with Shionogi), offers a novel dual orexin receptor antagonist (DORA) mechanism that promotes sleep without next‑morning drowsiness, withdrawal or rebound insomnia.
Who’s behind it?
Nxera Pharma (formerly Sosei Heptares) develops daridorexant (discovered by Idorsia) for insomnia, approved in Japan and multiple regions. The trial builds on global phase 3 data showing significant improvements in sleep onset/maintenance.
How was it achieved?
The 28‑day study randomised adults/elderly with insomnia to daridorexant 50mg or placebo, evaluating efficacy/safety. Results align with prior data, confirming tolerability and efficacy in Asian populations.
What’s next?
Nxera plans South Korea MAA submission Q1 2026, with approval expected Q1 2027. Quviviq expands regionally after Japan launch.
What are people saying?
Nxera highlighted consistent global data, positioning daridorexant as a leading DORA. Professor Yuping Wang noted no withdrawal/rebound insomnia.