Drugs / Daridorexant
Daridorexant
also known as
ACT-541468 · ACT-541468 HYDROCHLORIDE · ACT-541468A · DARIDOREXANT HYDROCHLORIDE · DEA NO. 2410 · DTX · Nemorexant · Nemorexant hydrochloride · +1 more
Small molecule targets CYP3A4, HCRTR1, HCRTR2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | QUVIVIQ | — | 2024-09-30 | fda.gov ↗ |
| Approved | EU (EMA) | Quviviq | — | 2022-04-29 | europa.eu ↗ |
| Approved | US (FDA) | QUVIVIQ | — | 2022-01-07 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials | ||||||
| Phase 1 | NCT06326723 | Sep → Dec 2023 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05877222 | Jun → Aug 2023 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05632393 | Jan → Apr 2023 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05702177 | Jan → Apr 2023 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05480475 | Sep 2022 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05480488 | Aug → Sep 2022 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05458193 | Aug 2022 → Feb 2023 | obstructive sleep apnea syndrome | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04390334 | May → Jun 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04250506 | Feb → Jul 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04024332 | Sep 2019 → Aug 2020 | impaired renal function disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03907215 | Apr → Jun 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03892902 | Mar → Oct 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03765294 | Mar → Nov 2019 | obstructive sleep apnea syndrome | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03799978 | Mar 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03646864 | Nov 2018 → Sep 2019 | chronic obstructive pulmonary disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03657355 | Sep 2018 → Aug 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03609775 | Aug → Oct 2018 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03713242 | Feb 2018 → Feb 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03339752 | Oct → Dec 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03101189 | Mar → Apr 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03017495 | Jan → Feb 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02571855 | Oct 2015 → Feb 2016 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02526888 | Sep → Nov 2015 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02919319 | Feb → May 2015 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07532252 | Jan 2027 → Aug 2030 expected | alcohol-related disorders | Johns Hopkins University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07701928 | Sep 2026 → Dec 2030 expected | alcohol dependence, insomnia | Sterling McPherson | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07213349 | Oct 2025 → Dec 2028 expected | Alzheimer disease | Douglas Mental Health University Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07217912 | Oct 2025 → Nov 2027 expected | delirium | University of Rochester | Recruiting | No outcome recorded |
| Phase 2 | NCT06630390 | Nov 2024 → Feb 2025 | delirium | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT05422612 | Nov 2023 → Jul 2028 | post-traumatic stress disorder | Global Coalition for Adaptive Research | Suspended | No outcome recorded |
| Phase 2 | NCT05948540 | Nov 2023 → Apr 2028 | post-traumatic stress disorder | Global Coalition for Adaptive Research | Suspended | No outcome recorded |
| Phase 2 | NCT05423717 | Sep 2022 → Jan 2026 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02841709 | Nov 2016 → May 2017 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02839200 | Oct 2016 → Apr 2017 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07028697 | Dec 2024 → Sep 2025 | insomnia | Nxera Pharma Korea Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06010693 | Aug 2023 → Apr 2024 | insomnia | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03679884 | Oct 2018 → Feb 2021 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03545191 | Jun 2018 → Jan 2020 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03575104 | May 2018 → Apr 2020 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07555743 | Apr 2026 → Apr 2027 expected | insomnia, major depressive disorder | Bellvitge Biomedical Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07267559 | Oct 2025 → Sep 2026 expected | cognitive disorder | University of Oxford | Recruiting | No outcome recorded |
| Phase 4 | NCT05924425 | Mar 2024 → May 2027 expected | Alzheimer disease, insomnia | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 4 | NCT05597020 | Feb 2023 → Apr 2024 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07136415 Comparator | Feb 2026 → Feb 2031 expected | insomnia | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07328594 Comparator | Feb 2026 → Mar 2027 expected | insomnia, nicotine dependence | Legacy Health System | Not yet recruiting | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daridorexant | “Daridorexant (ACT-541468) is a potent dual orexin receptor antagonist under development for the treatment of sleep disorders.” PMID 33205362 ↗ Nov 202029“Daridorexant is a dual orexin receptor antagonist in clinical development for insomnia.” PMID 34002356 ↗ May 2021 |
| Known as | ACT-541468 | “The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder.” NCT03575104 ↗19“Daridorexant (ACT-541468) is a potent dual orexin receptor antagonist under development for the treatment of sleep disorders.” PMID 33205362 ↗ Nov 2020 “Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder” NCT03545191 ↗ “Daridorexant (ACT-541468) administered as film-coated tablets for oral use.” NCT04250506 ↗ “a single dose of 50 mg ACT-541468 (Treatment A) on Day 1” NCT03907215 ↗ |
| Known as | ACT-541468 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | ACT-541468A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | DARIDOREXANT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | DEA NO. 2410 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | DTX | “sleep medication, daridorexant (DTX), can help decrease drinking in people who have alcohol use disorder (AUD) and insomnia.” NCT07701928 ↗ |
| Known as | Nemorexant | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | Nemorexant hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | Quviviq | “Daridorexant (brand name Quviviq) is FDA-approved for the treatment of insomnia in adults.” NCT07267559 ↗ |
| Action | Inhibit | “Daridorexant, a dual orexin receptor antagonist, is approved for the treatment of insomnia disorder in adults.” PMID 40660750 ↗ Jul 2025 |
| Modality | Small molecule | — CHEMBL4297590 ↗ |
| Route | Oral | “Oral capsule (25 mg) as single dose” NCT02526888 ↗ |
| Target | CYP3A4 | “Daridorexant at 50 mg is classified as a weak CYP3A4 inhibitor after single- and multiple-dose administration once daily at steady state.” PMID 38472696 ↗ Mar 2024 |
| Target | HCRTR1 | “Orexin receptor 1 antagonist” CHEMBL4297590 ↗ |
| Target | HCRTR2 | “Orexin receptor 2 antagonist” CHEMBL4297590 ↗ |