Quviviq

(Daridorexant)

ApprovedSmall molecule

Daridorexant is used to help people who have trouble falling asleep or staying asleep. It works by blocking a chemical in the brain that promotes wakefulness, allowing people to sleep better.[2] Quviviq is currently approved and in use across 9 indications[4].[1]

Quviviq is one of 331 small molecule programs targeting Cognitive impairment. It is currently in Approved.

Indications

Total Trials

Active Trials

330

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cognitive ImpairmentActive, not recruiting

Alzheimer DiseaseRecruiting

DeliriumActive, not recruiting

Obstructive Sleep ApneaApproved

InsomniaActive, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

Post-Traumatic Stress DisorderApproved

Liver DiseaseApproved

Renal InsufficiencyApproved

Cognitive ImpairmentApproved

Active, not recruiting

Alzheimer DiseaseApproved

Recruiting

DeliriumPhase 2

Active, not recruiting

Obstructive Sleep ApneaApproved

Approved

InsomniaApproved

Active, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

Approved

Post-Traumatic Stress DisorderApproved

Approved

Liver DiseaseApproved

Approved

Renal InsufficiencyApproved

Approved

Competition

Competitive Landscape

557 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

Quviviq

Idorsia Pharmaceuticals Ltd.

Approved

26 2

Veramyst

GSK

Preclinical

26 3

Flovent

GSK

Preclinical

6 4

Spiriva

Boehringer Ingelheim

Preclinical

15 5

Aclidinium Bromide

AstraZeneca

Preclinical

21 6

Formoterol Fumarate

AstraZeneca

Preclinical

11 7

Calciferol

Alnylam Pharmaceuticals

Preclinical

—8

Proventil

Mylan Pharmaceuticals Inc

Preclinical

3 9

Duragesic

CCephalon

Preclinical

2 10

Narcan

SScienture

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

ESS

NCT07267559

Q3 2027

Post-ApprovalNot yet recruiting

Alertness

NCT07328594

Q4 2027

Phase 2Recruiting

Delirium

NCT07217912

Q1 2028

ApprovedRecruiting

Alzheimer Disease

NCT05924425

Clinical

Trials by Indication[1]

Insomnia6 trials

A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 3·NCT06010693·206 enrolled

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 4·NCT05597020·60 enrolled

Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

Enrolling by invitation·PPeriPharm··NCT06311864·100 enrolled

Show 3 more trials

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Completed·NNxera Pharma Korea Co., Ltd.·Phase 3·NCT07028697·164 enrolled

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 3·NCT03545191·930 enrolled

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 2·NCT05423717·166 enrolled

Pregnancy2 trials

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

Recruiting· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.··NCT06498128·785 enrolled

Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Active, not recruiting· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.··NCT06393504·2,095 enrolled

Delirium2 trials

Daridorexant to Prevent Delirium After Heart Surgery

Completed·UUniversity of Rochester·Phase 2·NCT06630390·11 enrolled

Daridorexant to Prevent Post-cardiotomy Delirium

Recruiting·UUniversity of Rochester·Phase 2·NCT07217912·80 enrolled

Alzheimer disease2 trials

Daridorexant for Alzheimer Disease Prevention

Recruiting·—·Phase 2·NCT07213349·240 enrolled

Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

Recruiting·UUniversity Hospital, Montpellier·Approved·NCT05924425·62 enrolled

Single Dose1 trial

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT04250506·36 enrolled

12 more indications

Menopause1 trial

Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

Recruiting·—·Phase 4·NCT07136415·1,000 enrolled

Sleep1 trial

A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05458193·20 enrolled

Breast1 trial

A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05632393·10 enrolled

Efficacy and Safety1 trial

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 3·NCT03575104·924 enrolled

Statin1 trial

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05480475·24 enrolled

Phase 11 trial

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05877222·38 enrolled

ESS1 trial

Dual Orexin Antagonism and Emotion and Affective Processing Study

Recruiting·UUniversity of Oxford·Phase 4·NCT07267559·62 enrolled

TED1 trial

A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05702177·36 enrolled

Elderly1 trial

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 3·NCT03679884·804 enrolled

Midazolam1 trial

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

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05480488·18 enrolled

Alertness1 trial

Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking

Not yet recruiting·LLegacy Health System·Phase 4·NCT07328594·44 enrolled

Unspecified2 trials

Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·NCT06326723·32 enrolled

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.

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT04390334·24 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 7, 2022

QUVIVIQ

NDA NDA214985

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Daridorexant. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Quviviq drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Daridorexant compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Daridorexant. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214985). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Quviviq. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Idorsia Pharmaceuticals Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Orexin Receptor 2 Antagonist; Orexin Receptor Antagonist; Orexin Receptor 1 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Idorsia Pharmaceuticals Ltd.

Patent Landscape[6]

Patent Cliff

Jun 12, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9732075Jun 12, 2033

10023560Dec 2, 2034

9790208Dec 2, 2034

Quviviq

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Insomnia6 trials

Pregnancy2 trials

Delirium2 trials

Alzheimer disease2 trials

Single Dose1 trial

Menopause1 trial

Sleep1 trial

Breast1 trial

Efficacy and Safety1 trial

Statin1 trial

Phase 11 trial

ESS1 trial

TED1 trial

Elderly1 trial

Midazolam1 trial

Alertness1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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