Drugs / Lemborexant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DAYVIGO | — | 2023-04-20 | fda.gov ↗ |
| Approved | US (FDA) | DAYVIGO | — | 2019-12-20 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT04890561 | May → Aug 2021 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04647383 | Jan 2021 → Feb 2022 | chronic obstructive pulmonary disease, obstructive sleep apnea syndrome | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04555733 | Oct 2020 → Jan 2021 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03483636 | Mar → Sep 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03471871 | Feb → Aug 2018 | obstructive sleep apnea syndrome | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03443063 | Feb → Aug 2018 | impaired renal function disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03451110 | Feb → Mar 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03440424 | Jan → Apr 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03158025 | Apr 2017 → Jul 2018 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03008447 | Nov 2016 → Jan 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02583451 | Nov 2015 → Jan 2017 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02350309 | Dec 2014 → Apr 2015 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02085967 | Feb → Apr 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02046213 | Feb → Apr 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02089412 | Feb → May 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02039089 | Jan → May 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01673451 | Aug 2012 → May 2013 | central nervous system disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01673880 | Aug → Oct 2012 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01463098 | Oct 2011 → Aug 2012 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07683442 | Sep 2026 → Jun 2028 expected | obstructive sleep apnea syndrome | Chulalongkorn University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05763329 | Feb 2023 → Feb 2025 | obstructive sleep apnea syndrome | Chulalongkorn University | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07695285 | Sep 2026 → Sep 2029 expected | delirium | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06981195 | May 2025 → Jul 2029 expected | insomnia, substance-related disorder | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 2 | NCT06823752 | May 2025 → Apr 2026 overdue | insomnia | Woolcock Institute of Medical Research | Recruiting | No outcome recorded |
| Phase 2 | NCT06648681 | May 2025 → Apr 2027 expected | delirium | University of British Columbia | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06928766 | May 2025 → May 2027 expected | obstructive sleep apnea syndrome | Flinders University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07480096 | Oct 2024 → Oct 2025 | cirrhosis of liver, hepatic encephalopathy, insomnia | Indonesia University | Completed | No outcome recorded |
| Phase 2 | NCT06843187 | Sep 2024 → Dec 2027 expected | insomnia, major depressive disorder | Unity Health Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06274528 | Mar 2024 → Mar 2030 expected | Alzheimer disease | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT05728736 | Mar → Sep 2023 | Alzheimer disease | Brendan Lucey | Withdrawn | No outcome recorded |
| Phase 2 | NCT05594589 | Nov 2022 → Apr 2024 | sleep disorder, initiating and maintaining sleep | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03001557 | Dec 2016 → Jul 2018 | circadian rhythm sleep disorder, irregular sleep wake type | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01995838 | Nov 2013 → Apr 2014 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06496282 | Aug 2024 → May 2026 overdue | — | Phramongkutklao College of Medicine and Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04549168 | Nov 2020 → Mar 2023 | sleep disorder, initiating and maintaining sleep | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02952820 | Nov 2016 → Jan 2019 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02783729 | May 2016 → Jan 2018 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07384429 | Aug → Dec 2026 expected | Parkinson disease, insomnia, movement disorder | YangPan | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07407400 | Apr 2026 → Jul 2027 expected | delirium, sleep disorder | Mahidol University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06093126 | Dec 2023 → Dec 2028 expected | frontotemporal dementia, insomnia | Nova Scotia Health Authority | Recruiting | No outcome recorded |
| Phase 4 | NCT05344443 | Mar 2022 → Nov 2024 | circadian rhythm sleep disorder, shift work type | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT04742699 | Mar 2021 → Jun 2022 | insomnia | Kurume University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06779149 | Apr 2025 → Feb 2027 expected | insomnia | Laval University | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04818086 Comparator | May 2021 → Apr 2023 | substance-related disorder | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06231641 Comparator | Jan 2024 → Mar 2026 | circadian rhythm sleep disorder, shift work type | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06262594 Comparator | Oct 2024 → Apr 2026 overdue | epilepsy | University of Manitoba | Recruiting | No outcome recorded |
| Phase 3 | NCT05458609 Comparator | Feb 2023 → Jan 2024 | alcohol-related disorders | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06874855 Comparator | Mar 2023 → May 2027 expected | circadian rhythm sleep disorder, delayed sleep phase type | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05463861 Comparator | Feb 2022 → Jan 2026 | circadian rhythm sleep disorder, delayed sleep phase type | Stanford University | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lemborexant | “the dual orexin-receptor antagonist lemborexant (LEM) in older adults” PMID 39120786 ↗ Aug 202440 |
| Known as | Dayvigo | “Lemborexant (Dayvigo) is a Dual Orexin Receptor Antagonist approved by Health Canada for the treatment of adult with insomnia, characterized by difficulties with sleep onset...” NCT06779149 ↗4“Lemborexant (trade name Dayvigo), 10mg capsules, administered orally” NCT06981195 ↗ “Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1” NCT05763329 ↗ “Lemborexant 5 MG [Dayvigo] Period 1” NCT07683442 ↗ “Lemborexant 5 MG [Dayvigo]” NCT06231641 ↗ |
| Known as | E2006 | “Lemborexant (E2006)” NCT03440424 ↗ |
| Known as | LEM | “As part of a human abuse potential (HAP) study of lemborexant (LEM), the effects of therapeutic (LEM 10 mg), and supratherapeutic doses of LEM 20 mg and LEM 30 mg on cognition...” PMID 35748777 ↗ Jun 20226“OBJECTIVE: To evaluate effects of lemborexant (LEM), a dual orexin receptor antagonist, on next-morning sleep propensity assessed by a modified Multiple Sleep Latency Test...” PMID 37193566 ↗ Jul 2021 “This study evaluated the efficacy and safety of lemborexant (LEM), a dual orexin-receptor antagonist, in participants with insomnia disorder in China.” PMID 41442783 ↗ Dec 2025 “lemborexant (LEM) 10 mg (LEM10), a competitive dual orexin-receptor antagonist” PMID 40848323 ↗ Aug 2025 “the dual orexin-receptor antagonist lemborexant (LEM) in older adults.” PMID 39120786 ↗ Aug 2024 “lemborexant (LEM), a dual orexin receptor antagonist” PMID 39823487 ↗ Jan 2025 “Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)” NCT04742699 ↗ |
| Action | Inhibit | “a dual orexin receptor antagonist” PMID 37193566 ↗ Jul 2021 |
| Modality | Small molecule | — CHEMBL3545367 ↗ |
| Route | Oral | “single oral doses of E2006” NCT01463098 ↗ |
| Target | HCRTR1 | “Orexin receptor 1 antagonist” CHEMBL3545367 ↗ |
| Target | HCRTR2 | “Orexin receptor 2 antagonist” CHEMBL3545367 ↗ |