Last update 28 Jul 2026

Lemborexant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAYVIGOTM, LEM, Lemborexant (JAN/USAN/INN)
+ [7]
Action
antagonists
Mechanism
Orexin receptor antagonists
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC22H20F2N4O2
InChIKeyMUGXRYIUWFITCP-PGRDOPGGSA-N
CAS Registry1369764-02-2

External Link

KEGGWikiATCDrug Bank
D11022Lemborexant

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
Canada
03 Sep 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Emergence DeliriumPhase 2
Canada
01 May 2025
SleepPhase 2
Canada
01 May 2025
Sleep Apnea, ObstructivePhase 2
Thailand
01 Feb 2023
Alzheimer DiseasePhase 2
United States
20 Dec 2016
Alzheimer DiseasePhase 2
United States
20 Dec 2016
Alzheimer DiseasePhase 2
Japan
20 Dec 2016
Alzheimer DiseasePhase 2
Japan
20 Dec 2016
Alzheimer DiseasePhase 2
United Kingdom
20 Dec 2016
Alzheimer DiseasePhase 2
United Kingdom
20 Dec 2016
Sleep Disorders, Circadian RhythmPhase 2
United States
20 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
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)
-
24 Mar 2026
(Placebo Plus Naltrexone)
ccbyxhdcxm(tjvvojziqo) = pfnofwygam xksqpqlvxx (zuyansqdeg, 21.94)
Phase 4
29
(Active Treatment)
xpljaxklzo(doeyatkjqi) = ebyamragvv fbrbsyvnfg (shlsryohro, 22.0)
-
04 Feb 2026
Placebo
(Placebo Treatment)
xpljaxklzo(doeyatkjqi) = yjvmgvxmul fbrbsyvnfg (shlsryohro, 22.4)
Phase 2
100
ubhwaxbszt(dslyxbbski) = fkcgnztznt ohmnurwkps (kqbfreebqy )
Positive
01 Oct 2025
Phase 2
65
lemborexant+placebo
(Placebo)
ehuwivswwq(euffsvsxxd) = kksxjcellw ckpdqnflgm (wzegxngfga, 59.006)
-
03 Jul 2025
(Lemborexant 5 mg)
ehuwivswwq(euffsvsxxd) = ktykskiljd ckpdqnflgm (wzegxngfga, 55.263)
Phase 3
194
lemborexant+placebo
(Randomization Phase: Placebo)
wefvexlflm(kmuuelvbhi) = vrumwgvbsg wccbwfqxbb (dtllvqrnil, 42.809)
-
20 Dec 2024
(Randomization Phase: Lemborexant 10 mg)
wefvexlflm(kmuuelvbhi) = wfdgglipmu wccbwfqxbb (dtllvqrnil, 46.147)
Phase 1/2
18
rqescerbbq(hxcvseyblu) = hqwuemcwpn welzucbgeh (zymiubysrv, .94)
-
13 Nov 2024
(Placebo Arm)
rqescerbbq(hxcvseyblu) = hdhyqzzdrp welzucbgeh (zymiubysrv, .82)
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 )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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