Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
Market
0.0%
Details
- Resolved Date
- 3/30/26
- Study Completion
- 2/5/26
- Company
- Idorsia Pharmaceuticals Ltd.
- Ticker
- IDIA.SW
- Type
- Trial Status
- Completed
- Trial Size
- 166
- Volume
- $0
- NCT
- NCT05423717
- Drug Description
- This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Public readout is clearly positive for this exact Phase 2 trial. Idorsia announced positive top-line results for NCT05423717, citing a statistically significant dose-dependent improvement in total sleep time plus clinically meaningful multi-measure benefits and placebo-like safety; trade coverage framed it as a Phase 2 win.
Sources
Sponsoridorsia.com3/30/26
Idorsia’s daridorexant delivers outstanding results in a Phase 2 study in children with insomnia disorder
Sponsor says NCT05423717 had positive top-line Phase 2 results: statistically significant dose-dependent improvement in total sleep time, clinically meaningful sleep gains, and placebo-like safety/tolerability.
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Web Searchfiercepharma.com3/30/26
Idorsia eyes pediatric insomnia use with midstage trial win for sleep med Quviviq
Independent trade coverage described the pediatric daridorexant study as a Phase 2 trial win after the company reported positive results.
View source
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