Idorsia Gets US FDA Breakthrough Therapy Designation for Pediatric Insomnia Disorder Drug

MT Newswires · 1d ago
01:41 AM EST, 11/04/2026 (MT Newswires) -- Idorsia's (IDIA.SW) daridorexant received the breakthrough therapy designation from the US Food and Drug Administration for insomnia disorder in patients aged 10 to 18 years. The designation is backed by the results of a phase 2 study, which showed a significant dose-dependent improvement in total sleep time in the overall pediatric population, with pronounced efficacy in patients with neurodevelopmental disorders, the Swiss biopharmaceutical company said Wednesday. The company intends to launch a pediatric phase 3 clinical development program in the second half of 2027.