Daridorexant
- Generic Name
- Daridorexant
- Brand Names
- Quviviq
- Drug Type
- Small Molecule
- Chemical Formula
- C23H23ClN6O2
- CAS Number
- 1505484-82-1
- Unique Ingredient Identifier
- LMQ24G57E9
- Background
Daridorexant, formerly known as nemorexant, is a selective dual orexin receptor antagonist used to treat insomnia. Insomnia is characterized by difficulties with sleep onset and/or sleep maintenance and impairment of daytime functioning. It chronically affects the person's daily functioning and long-term health effects, as insomnia is often associated with c...
- Indication
In the US and Europe, daridorexant is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The European prescribing information states that insomnia should be characterized by symptoms that are present for at least three months and have a considerable impact on daytime functionin...
- Associated Conditions
- Insomnia
- Associated Therapies
- -
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
- Conditions
- Interventions
- First Posted Date
- 2024-07-12
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 785
- Registration Number
- NCT06498128
- Locations
- 🇺🇸
IQVIA US Office, Durham, North Carolina, United States
🇨🇦Jodha Tishon, Toronto, Ontario, Canada
🇫🇷Hôpital Gui de Chauliac, Montpellier, France
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
- Conditions
- Interventions
- First Posted Date
- 2024-05-01
- Last Posted Date
- 2024-05-01
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 2095
- Registration Number
- NCT06393504
- Locations
- 🇺🇸
Carelon Research, Wilmington, Delaware, United States
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
- First Posted Date
- 2024-03-22
- Last Posted Date
- 2024-03-22
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Target Recruit Count
- 32
- Registration Number
- NCT06326723
- Locations
- 🇨🇳
Nanjing Drum Tower hospital, Nanjing, Jiangsu, China
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
- First Posted Date
- 2023-08-24
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Target Recruit Count
- 206
- Registration Number
- NCT06010693
- Locations
- 🇨🇳
The Second People's Hospital Of Hefei, Hefei, Anhui, China
🇨🇳Xuanwu Hospital of Capital Medical University, Beijing, Beijing, China
🇨🇳Beijing Huilongguan Hospital, Beijing, Beijing, China
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
- First Posted Date
- 2022-11-30
- Last Posted Date
- 2023-05-12
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 10
- Registration Number
- NCT05632393
- Locations
- 🇺🇸
Labcorp Clinical Research Unit Inc., Madison, Wisconsin, United States
A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia
- First Posted Date
- 2022-10-27
- Last Posted Date
- 2024-05-22
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 60
- Registration Number
- NCT05597020
- Locations
- 🇺🇸
Accellacare Research of Cary, Cary, North Carolina, United States
🇺🇸Quantum Clinical Trials, Miami Beach, Florida, United States
🇺🇸Clinical Research Center of Florida, Pompano Beach, Florida, United States
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
- First Posted Date
- 2022-07-29
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 18
- Registration Number
- NCT05480488
- Locations
- 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany
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
- Conditions
- Interventions
- First Posted Date
- 2022-07-29
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT05480475
- Locations
- 🇨🇿
CEPHA s.r.o., Pilsen, Czechia
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
- Conditions
- Interventions
- First Posted Date
- 2022-07-14
- Last Posted Date
- 2023-04-04
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 20
- Registration Number
- NCT05458193
- Locations
- 🇩🇪
ASR Advanced Sleep Research GmbH, Berlin, Germany
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.
- First Posted Date
- 2020-05-15
- Last Posted Date
- 2020-09-16
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT04390334
- Locations
- 🇩🇪
CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany
Drug Development Updates
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