How many clinical trials are studying Daridorexant 50 mg?

3 recruiting trials in our tracked data involve Daridorexant 50 mg.

What conditions is Daridorexant 50 mg being studied for?

In our tracked recruiting trials, Daridorexant 50 mg is being studied in trials for Alzheimer's disease, Alzheimer Disease, Alzheimer Disease (AD).

Daridorexant 50 mg: clinical trials recruiting now

Q: Is Daridorexant 50 mg FDA-approved?

Yes. According to the FDA drug label available through openFDA, Daridorexant 50 mg is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Daridorexant 50 mg appears in the FDA drug-label database. Marketed as QUVIVIQ.
Drug class: Orexin Receptor Antagonist (FDA established pharmacologic class)
Mechanism of action: Orexin Receptor Antagonists (as stated on the FDA label)

FDA-approved use

QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1) ] . QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )

FDA label via openFDA

Phase breakdown

Phase 2 2 Phase 4 1

Conditions being studied

Condition	Trials
Alzheimer's disease · Daridorexant 50 mg for Alzheimer's disease	3
Alzheimer Disease	1
Alzheimer Disease (AD)	1
Insomnia Disorder	1
Postoperative Cognitive Decline	1
Postoperative Delirium	1
Sleep	1

Recruiting trials involving Daridorexant 50 mg

Daridorexant for Alzheimer Disease Prevention
NCT07213349 · Phase: Phase 2 · Ages: 50 Years to 90 Years · Sex: All (male and female) · 1 location
Daridorexant to Prevent Post-cardiotomy Delirium
NCT07217912 · Phase: Phase 2 · Ages: 60 Years and older · Sex: All (male and female) · 1 location
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
NCT05924425 · Phase: Phase 4 · Ages: 60 Years to 85 Years · Sex: All (male and female) · 1 location

Common questions

Is Daridorexant 50 mg FDA-approved?

Yes, marketed as QUVIVIQ.

How many recruiting trials involve Daridorexant 50 mg?

3 recruiting trials across 7 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.