Drug Type Small molecule drug |
Synonyms DAYVIGOTM, LEM, Lemborexant (JAN/USAN/INN) + [7] |
Target |
Action antagonists |
Mechanism Orexin receptor antagonists |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Canada (03 Sep 2019), |
Regulation- |
Molecular FormulaC22H20F2N4O2 |
InChIKeyMUGXRYIUWFITCP-PGRDOPGGSA-N |
CAS Registry1369764-02-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11022 | Lemborexant |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Sleep Initiation and Maintenance Disorders | Canada | 03 Sep 2019 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Emergence Delirium | Phase 2 | Canada | 01 May 2025 | |
| Sleep | Phase 2 | Canada | 01 May 2025 | |
| Sleep Apnea, Obstructive | Phase 2 | Thailand | 01 Feb 2023 | |
| Alzheimer Disease | Phase 2 | United States | 20 Dec 2016 | |
| Alzheimer Disease | Phase 2 | United States | 20 Dec 2016 | |
| Alzheimer Disease | Phase 2 | Japan | 20 Dec 2016 | |
| Alzheimer Disease | Phase 2 | Japan | 20 Dec 2016 | |
| Alzheimer Disease | Phase 2 | United Kingdom | 20 Dec 2016 | |
| Alzheimer Disease | Phase 2 | United Kingdom | 20 Dec 2016 | |
| Sleep Disorders, Circadian Rhythm | Phase 2 | United States | 20 Dec 2016 |
Phase 3 | 1,763 | xcnfrpphtq(ibjjansdhe) = dmnvchqjwq dkhlkrfguo (oqhvyaoqfm ) | Positive | 25 Apr 2026 | |||
xcnfrpphtq(ibjjansdhe) = akwvhzyjvi dkhlkrfguo (oqhvyaoqfm ) | |||||||
Phase 3 | 8 | (Lemborexant Plus Naltrexone) | ccbyxhdcxm(tjvvojziqo) = ugvlalxfko xksqpqlvxx (zuyansqdeg, 16.77) View more | - | 24 Mar 2026 | ||
(Placebo Plus Naltrexone) | ccbyxhdcxm(tjvvojziqo) = pfnofwygam xksqpqlvxx (zuyansqdeg, 21.94) View more | ||||||
Phase 4 | 29 | (Active Treatment) | xpljaxklzo(doeyatkjqi) = ebyamragvv fbrbsyvnfg (shlsryohro, 22.0) View more | - | 04 Feb 2026 | ||
Placebo (Placebo Treatment) | xpljaxklzo(doeyatkjqi) = yjvmgvxmul fbrbsyvnfg (shlsryohro, 22.4) View more | ||||||
Phase 2 | 100 | ubhwaxbszt(dslyxbbski) = fkcgnztznt ohmnurwkps (kqbfreebqy ) View more | Positive | 01 Oct 2025 | |||
Phase 2 | 65 | lemborexant+placebo (Placebo) | ehuwivswwq(euffsvsxxd) = kksxjcellw ckpdqnflgm (wzegxngfga, 59.006) View more | - | 03 Jul 2025 | ||
(Lemborexant 5 mg) | ehuwivswwq(euffsvsxxd) = ktykskiljd ckpdqnflgm (wzegxngfga, 55.263) View more | ||||||
Phase 3 | 194 | lemborexant+placebo (Randomization Phase: Placebo) | wefvexlflm(kmuuelvbhi) = vrumwgvbsg wccbwfqxbb (dtllvqrnil, 42.809) View more | - | 20 Dec 2024 | ||
(Randomization Phase: Lemborexant 10 mg) | wefvexlflm(kmuuelvbhi) = wfdgglipmu wccbwfqxbb (dtllvqrnil, 46.147) View more | ||||||
Phase 1/2 | 18 | (Lemborexant Arm) | rqescerbbq(hxcvseyblu) = hqwuemcwpn welzucbgeh (zymiubysrv, .94) View more | - | 13 Nov 2024 | ||
Placebo+Buprenorphine-naloxone (Placebo Arm) | rqescerbbq(hxcvseyblu) = hdhyqzzdrp welzucbgeh (zymiubysrv, .82) View more | ||||||
Not Applicable | - | irazuygbit(qjkipcrrrs) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity zqdaylngjn (fxynjlhgdn ) | - | 09 Apr 2024 | |||
Phase 1 | - | 8 | kwhkgirsdu(jjbovnrqsj) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study syokpdmpqz (clebsykgvb ) | Positive | 01 Jan 2024 | ||
Phase 1 | 33 | dfsvwxnjje(xgniogrwrc) = sgunyxfeks uwucpkgole (cssegdkkea ) | Positive | 01 Jan 2024 | |||
Placebo | dfsvwxnjje(xgniogrwrc) = asppwvklbq uwucpkgole (cssegdkkea ) |





