QUVIVIQ (daridorexant hydrochloride)
QUVIVIQ is indicated for the treatment of Insomnia.
How QUVIVIQ Works
Daridorexant is a dual orexin receptor antagonist (DORA). It works by antagonizing the orexin receptors OX1R and OX2R, thereby blocking the binding of the wake-promoting neuropeptides orexin A and orexin B. This mechanism is thought to suppress the physiological wake drive rather than inducing general CNS sedation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-01-07
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET
QUVIVIQ Approval History
What QUVIVIQ Treats
1 indicationsQUVIVIQ is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
QUVIVIQ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to QUVIVIQ
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07136415 CELESTE | 2025P001920 | Ph 4 | recruiting | Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms |
| NCT07028697 | NPK-DAR-301 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder |
| NCT05597020 results posted | ID-078A401 2022-501246-30-00 | Ph 4 | completed | A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia |
| NCT06010693 | SIM0808-301 | Ph 3 | completed | A Study of Daridorexant in Chinese Patients With Insomnia Disorder |
| NCT06326723 | SIM0808-101 | Ph 1 | completed | Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects |
| NCT05632393 | ID-078-122 | Ph 1 | completed | A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women |
| NCT05458193 | ID-078-121 2022-000098-23 | Ph 1 | completed | A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep |
| NCT05480475 | ID-078-125 | Ph 1 | completed | 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 |
| NCT05480488 | ID-078-126 | Ph 1 | completed | 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 |
| NCT03575104 results posted | ID-078A302 | Ph 3 | completed | Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep |
| NCT04390334 | ID-078-120 2020-000653-27 | Ph 1 | completed | 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. |
| NCT04250506 | ID-078-117 2019-003843-31 | Ph 1 | completed | A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
QUVIVIQ FDA Label Details
Indications & Usage
FDA Label (PDF)QUVIVIQ is indicated for the treatment of Insomnia.
QUVIVIQ Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for QUVIVIQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 12 active patents
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • 17 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment