Positive Phase III trial of Nxera’s daridorexant

19 January 2026

Japan-based Nxera Pharma (TYO: 4565) announced that positive top-line results were obtained from a Phase III study conducted in South Korea evaluating daridorexant 50mg in adult and elderly patients with insomnia.

The company plans to submit a marketing authorization application for daridorexant in South Korea in the first quarter of 2026, with approval in South Korea expected in the first quarter of 2027.

Daridorexant is approved and being marketed in Japan as Quviviq under a commercialization agreement between Nxera and Shionogi (TYO: 4507). Quviviq, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the USA, Canada, and multiple European countries, and marketed by Simcere Pharmaceuticals (HK: 2096) in China and Hong Kong.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK