91 completed, 7 not yet recruiting, 6 terminated, 4 suspended. 66 Phase 1, 22 Phase 2, 16 Phase 3, 3 Phase 4, 1 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002 Intervention D SLS-002, Intervention D Placebo - Post Traumatic Stress Disorder | Phase 2 | Suspended | Global Coalition for Adaptive Research | 200 | 2028-05-01 | 2026-05-20 |
| Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone Intervention B Vilazodone Hydrochloride (HCl), Intervention B Placebo - Post Traumatic Stress Disorder | Phase 2 | Not yet recruiting | Global Coalition for Adaptive Research | 200 | 2027-08-01 | 2026-05-20 |
| Daridorexant for Alcohol Use Disorder Daridorexant 50 mg, Placebo - Alcohol Use Disorder | Phase 2 | Not yet recruiting | Johns Hopkins University | 150 | 2027-01-01 | 2026-04-20 |
| A Study to Learn How Well Lucerastat Works and How Safe it is in Untreated Adult Male Participants With Fabry Disease Lucerastat - Fabry Disease | Phase 3 | Not yet recruiting | Idorsia Pharmaceuticals Ltd. | 16 | 2026-09-01 | 2026-08-21 |
| A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day Daridorexant, Placebo - Insomia Disorder | Phase 3 | Not yet recruiting | Idorsia Pharmaceuticals Ltd. | 344 | 2026-09-01 | 2026-09-28 |
| IMPACT-HTN Study of Patients With Hypertension Hypertension (HTN), Hypertension | Not yet recruiting | Vivek Bhalla | 100 | 2026-07-01 | 2026-06-29 | |
| A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo ACT-777991, Placebo - Non-Segmental Vitiligo | Phase 2 | Not yet recruiting | Idorsia Pharmaceuticals Ltd. | 30 | 2026-06-01 | 2026-06-25 |
| Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia Daridorexant 50 mg, Placebo - Insomnia, Major Depressive Disorder | Phase 4 | Not yet recruiting | Institut d'Investigació Biomèdica de Bellvitge | 134 | 2026-04-01 | 2026-04-29 |
| Sleep in Collegiate Baseball Players Sleep and diet - Sleep | Not applicable | Completed | Columbia University | 38 | 2025-09-16 | 2025-12-18 |
| A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormonal Contraceptives Ethinyl Estradiol / Levonorgestrel Oral Tablet, Aprocitentan - Drug Drug Interaction | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 19 | 2025-01-18 | 2025-03-11 |
| Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ® Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication - Insomnia | Recruiting | Idorsia Pharmaceuticals Ltd. | 785 | 2024-11-21 | 2025-12-02 | |
| Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada Daridorexant 50 mg - Insomnia | Completed | PeriPharm | 90 | 2024-06-20 | 2026-05-27 | |
| Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease Daridorexant 50 mg, Placebo, Polysomnography - Alzheimer Disease, Insomnia Disorder | Phase 4 | Recruiting | University Hospital, Montpellier | 62 | 2024-03-13 | 2026-06-25 |
| Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication - Insomnia Disorder | Active not recruiting | Idorsia Pharmaceuticals Ltd. | 2095 | 2023-11-30 | 2025-08-19 | |
| Department of Defense PTSD Adaptive Platform Trial - Master Protocol Intervention A Fluoxetine Hydrochloride (HCl), Intervention A Placebo, Intervention B Vilazodone Hydrochloride (HCl) - Post Traumatic Stress Disorder | Phase 2 | Suspended | Global Coalition for Adaptive Research | 800 | 2023-11-02 | 2026-06-30 |
| Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine Intervention A Fluoxetine Hydrochloride (HCl), Intervention A Placebo - Post Traumatic Stress Disorder | Phase 2 | Suspended | Global Coalition for Adaptive Research | 200 | 2023-11-02 | 2026-05-20 |
| Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant Intervention C Daridorexant, Intervention C Placebo - Post Traumatic Stress Disorder | Phase 2 | Suspended | Global Coalition for Adaptive Research | 200 | 2023-11-02 | 2026-06-30 |
| 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 Daridorexant 10 mg, Daridorexant 25 mg - Healthy | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 38 | 2023-06-23 | 2023-08-16 |
| A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia Daridorexant, Placebo - Insomnia Disorder, Nocturia | Phase 4 | Completed | Idorsia Pharmaceuticals Ltd. | 60 | 2023-02-16 | 2025-04-18 |
| A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women Daridorexant - Healthy | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 10 | 2023-01-16 | 2023-05-12 |
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Sleep Initiation and Maintenance Disorders (14) · Fabry Disease (5) · Stress Disorders, Post-Traumatic (5) · Subarachnoid Hemorrhage (5) · Renal Insufficiency (3) · Vasospasm, Intracranial (3) · Essential Hypertension (2) · Hemorrhage (2) · Hypertension (2) · Pulmonary Arterial Hypertension (2) · Rhinitis, Allergic, Seasonal (2) · Alcoholism (1) · Alzheimer Disease (1) · Asthma (1) · Binge-Eating Disorder (1)
daridorexant (37) · aprocitentan (13) · migalastat (9) · clazosentan (7) · Midazolam (6) · 2-(2-(1-naphthoyl)-8-fluoro-3,4-dihydro-1H-pyrido(4,3-b)indol-5(2H)-yl)acetic acid (5) · ACT-1014-6470 (4) · tezosentan (4) · ACT-1004-1239 (3) · ACT-709478 (3) · Moxifloxacin (3) · Rosuvastatin Calcium (3) · Zolpidem (3) · ACT-389949 (2) · ACT-451840 (2)
Germany (44) · United States (40) · France (18) · Netherlands (18) · Czechia (17) · Canada (15) · Spain (14) · United Kingdom (14) · Switzerland (13) · Poland (12) · Italy (11) · Belgium (10) · Australia (9) · Israel (9) · Hungary (8)
Marie-Laure Boof, PhD (3) · Sara Mangialaio, MD (3) · Clemens Muehlan (2) · Alison Mackie, MSc (1) · Andre Denault, Prof. (1) · Andrea D'Armini, Prof. (1) · Angelina Marr, BSc. Pharm (1)
PMID 37526060, PMID 28088251, PMID 17986694, PMID 26721775, PMID 28392807, PMID 31394993, PMID 33595155, PMID 35065036, PMID 36054921, PMID 37477771, PMID 37796657, PMID 38302765, PMID 38644625, PMID 41217192, PMID 21640651, PMID 21998061, PMID 22403047, PMID 22678087, PMID 22890639, PMID 23523254, PMID 23581590, PMID 24095247, PMID 24425125, PMID 25280913, PMID 25421475, PMID 26248048, PMID 26428322, PMID 27000643, PMID 27062080, PMID 27827324, PMID 29946013, PMID 31299650, PMID 31642731, PMID 31836927, PMID 31953863, PMID 31994022, PMID 32063059, PMID 32341187, PMID 33109218, PMID 33131027, PMID 33205362, PMID 33305817, PMID 33389549, PMID 34002356, PMID 34331678, PMID 34480579, PMID 35306405, PMID 35431953, PMID 35686330, PMID 35782623
2018 (9), 2019 (7), 2017 (3), 2015 (2), 2016 (2), 2014 (1), 2025 (1)