Trial Profile

A Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to investigate the efficacy and safety of daridorexant in patients with insomnia disorder

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 12 Feb 2026

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At a glance

19 Jan 2026 According to a Nxera Pharma media release, the company plans to submit a marketing authorization application for daridorexant in South Korea in Q1 2026, with approval expected in Q1 2027.
19 Jan 2026 Results presented in the Nxera Pharma media release.
24 Sep 2024 According to a Nxera Pharma media release, the company has received approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) of its New Drug Application (NDA) for QUVIVIQ (daridorexant; ACT-541468) 25 and 50 mg for the treatment of adult patients with insomnia.

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