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
-

A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-01-31
Last Posted Date
2020-09-16
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
36
Registration Number
NCT04250506
Locations
🇨🇿

CEPHA s.r.o., Pilsen, Czechia

Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-07-18
Last Posted Date
2020-09-03
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
16
Registration Number
NCT04024332
Locations
🇩🇪

APEX GmbH, München, Germany

A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects

First Posted Date
2019-03-27
Last Posted Date
2019-10-31
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
56
Registration Number
NCT03892902
Locations
🇳🇱

Centre for Human Drug Research, Leiden, Netherlands

A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-01-10
Last Posted Date
2019-04-12
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
20
Registration Number
NCT03799978
Locations
🇨🇿

CEPHA s.r.o., Pilsen, Czechia

A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-12-05
Last Posted Date
2019-12-19
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
28
Registration Number
NCT03765294
Locations
🇩🇪

Advanced Sleep Research, Berlin, Germany

Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

First Posted Date
2018-09-05
Last Posted Date
2019-09-19
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
63
Registration Number
NCT03657355
Locations
🇨🇦

Altasciences Company Inc., Montreal, Canada

🇺🇸

Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.), Overland Park, Kansas, United States

A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Disease

First Posted Date
2018-08-24
Last Posted Date
2019-09-23
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
28
Registration Number
NCT03646864
Locations
🇩🇪

framol-med GmbH, Lungenpraxis, Rheinau, Germany

🇩🇪

Advanced Sleep Research, Berlin, Germany

🇩🇪

ZMS, Warendorf, Germany

and more 1 locations

A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

First Posted Date
2018-08-01
Last Posted Date
2018-10-15
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
22
Registration Number
NCT03609775
Locations
🇳🇱

Centre For Human Drug Research, Leiden, Netherlands

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2018-07-02
Last Posted Date
2022-03-25
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
924
Registration Number
NCT03575104
Locations
🇨🇦

Canadian Phase Onward Inc., Toronto, Ontario, Canada

🇺🇸

FutureSearch Trials of Neurology, LP, Austin, Texas, United States

🇺🇸

Neurotrials Research Incorporated, Atlanta, Georgia, United States

and more 82 locations

A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-11-13
Last Posted Date
2017-12-11
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
20
Registration Number
NCT03339752
Locations
🇨🇿

Cepha s.r.o., Pilsen, Czechia

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