Daridorexant 10 mg

DRUG3 trials

Sponsors

Idorsia Pharmaceuticals Ltd.

Conditions

HealthyInsomniaInsomnia Disorder

Phase 1

A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

CompletedNCT05877222

Idorsia Pharmaceuticals Ltd.Healthy

Start: 2023-06-23End: 2023-08-04Updated: 2023-08-16

Phase 2

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

CompletedNCT05423717

Idorsia Pharmaceuticals Ltd.Insomnia

Start: 2022-09-06End: 2026-02-05Updated: 2026-03-06

Phase 3

Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

CompletedNCT03679884

Idorsia Pharmaceuticals Ltd.Insomnia Disorder

Start: 2018-10-09End: 2021-02-22Updated: 2022-03-02

Related Papers

Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis.

2023-07-011 citations

Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant.

2023-06-073 citations

Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder.

2022-12-0938 citations

Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial.

2022-09-1322 citations

0521 Daridorexant (ACT-541468), A Dual Orexin Receptor Antagonist for the Treatment of Insomnia Disorder: Double Blind, Randomized, Phase 3 Studies for Efficacy and Safety in Adult and Elderly Patients

SLEEP2020-04-014 citations