Daridorexant
Sponsors
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL, Idorsia Pharmaceuticals Ltd., Jiangsu Simcere Pharmaceutical Co., Ltd., Nxera Pharma Korea Co., Ltd., Brigham and Women's Hospital
Conditions
HealthyHealthy VolunteerInsomniaInsomnia DisorderMenopausal WomenNocturiaObstructive Sleep Apnea of AdultPatients with major depressive episode and moderate to severe insomnia disorder
Phase 1
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
CompletedNCT04250506
Start: 2020-02-28End: 2020-07-22Updated: 2020-09-16
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.
CompletedNCT04390334
Start: 2020-05-13End: 2020-06-26Updated: 2020-09-16
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
CompletedNCT05458193
Start: 2022-08-17End: 2023-02-28Updated: 2023-04-04
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects
CompletedNCT05480475
Start: 2022-09-03End: 2022-09-17Updated: 2022-11-08
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects
CompletedNCT05480488
Start: 2022-08-23End: 2022-10-06Updated: 2022-11-08
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
CompletedNCT05632393
Start: 2023-01-16End: 2023-04-30Updated: 2023-05-12
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
CompletedNCT06326723
Start: 2023-09-04End: 2024-02-05Updated: 2024-03-22
Phase 3
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
CompletedNCT03575104
Start: 2018-05-29End: 2020-05-14Updated: 2022-03-25
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
CompletedNCT06010693
Start: 2023-08-28End: 2024-05-10Updated: 2024-10-30
A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
CompletedNCT07028697
Start: 2024-12-04End: 2025-10-21Updated: 2026-01-21
Phase 4
A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
CompletedNCT05597020
Start: 2023-02-16End: 2024-04-18Updated: 2025-04-18
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
RecruitingNCT07136415
Start: 2026-02-13End: 2031-02-01Target: 1000Updated: 2026-03-17
Efficacy and Safety of Daridorexant in Patients with Major Depressive Disorder (MDD) and Insomnia: Double-blind, randomized, controlled trial
Not yet recruitingCTIS2025-524794-16-00
Target: 134Updated: 2026-05-04
Unknown Phase
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Active, not recruitingNCT06393504
Start: 2023-11-30End: 2028-04-30Target: 2095Updated: 2025-08-19
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
RecruitingNCT06498128
Start: 2024-11-21End: 2033-03-31Target: 785Updated: 2025-12-02