CDEK
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lemborexant

Trade name: Dayvigo

Small moleculeapproved

Approved

Dec 20, 2019

Lemborexant is a dual orexin receptor antagonist, which inhibits orexin by binding competitively to two subtypes of orexin receptors. During normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully facilitate the initiation and maintenance of sleep by interfering with orexin neurotransmission with lemborexant. Extensive in vitro and non-clinical testing of lemborexant supported the supposition that lemborexant has a low risk of QT prolongation at therapeutic and supratherapeutic exposures in humans. A Phase III study of lemborexant in insomnia is underway, and in addition, Eisai has announced the initiation of Phase II clinical studies of lemborexant in patients with irregular sleep-wake rhythm disorder. — NCATS

Clinical trial activity

45 trials · 30 clinical orgs · 2 marketing orgs

Phase 1
21
Phase 2
20
Phase 3
7
Phase 4
5

Earliest trial started Oct 1, 2011 (NCT01463098)

Timeline

2010s

  1. Jan 1, 2011

    Eisai — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2013

    Eisai — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2016

    Eisai — Earliest Phase 3 Sponsor(trial)

  4. Dec 20, 2019

    Eisai — Earliest FDA Approval

  5. Dec 20, 2019

    Eisai — Marketing Organization

  6. Dec 20, 2019

    Eisai — NDA Organization

  7. Dec 20, 2019

    Sarepta Therapeutics — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 20, 2019

Chemistry & pharmacology

Loading structure…

SMILES

CC1=NC=C(OC[C@]2(C[C@H]2C(=O)NC3=NC=C(F)C=C3)C4=CC=CC(F)=C4)C(C)=N1
Mol. weight
410.4166 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • e-2006
  • e-2006
  • lemborexant
  • lemborexant
  • lemborexant
  • lemborexant

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06981195Phase 2May 27, 2025National Institute on Drug Abuse (NIDA), Virginia Commonwealth University
NCT06928766Phase 2May 1, 2025Flinders University
NCT06779149N/AFeb 28, 2025Laval University, Metropolitan University, University of Ottawa
NCT06843187Phase 2Feb 28, 2025Metropolitan University, Unity Health Toronto, University of Toronto
NCT06823752Phase 2Feb 28, 2025Woolcock Institute of Medical Research
NCT06648681Phase 2Nov 1, 2024Eisai, University of British Columbia
NCT06496282Phase 3Aug 31, 2024Government of Thailand, Silpakorn University
NCT06262594Phase 3Apr 18, 2024Duke University, University of Manitoba
NCT06274528Phase 2Mar 11, 2024Eisai, National Institute on Aging (NIA), National Institutes of Health (NIH), Washington University in St. Louis
NCT06231641Phase 2Jan 11, 2024Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
NCT06093126Phase 4Nov 1, 2023Government of Canada
NCT06874855Phase 4Mar 13, 2023Eisai, Stanford University, University of California, San Francisco
NCT05728736Phase 2Mar 1, 2023Eisai, Washington University in St. Louis
NCT05763329Phase 1/Phase 2 (Phase 2)Feb 1, 2023Chulalongkorn University
NCT05594589Phase 2Nov 30, 2022Eisai
NCT05458609Phase 3Aug 6, 2022Baylor University
NCT05344443Phase 4Mar 10, 2022University of California, San Francisco
NCT05463861Phase 4Feb 1, 2022Stanford University, University of California, San Francisco
NCT04890561Phase 1May 17, 2021Eisai
NCT04818086Phase 1/Phase 2 (Phase 2)May 3, 2021National Institute on Drug Abuse (NIDA), Virginia Commonwealth University
Showing 20 of 45 trials
Page 1 / 3

Organizations

Research & Development (30)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
EisaiFor profit312642011
Purdue PharmaceuticalsFor profit10032015
University of California, San FranciscoAcademic/Hospital3212022
Metropolitan UniversityAcademic/Hospital2022025
National Institute on Drug Abuse (NIDA)Government2012021
Stanford UniversityAcademic/Hospital2112022
Virginia Commonwealth UniversityAcademic/Hospital2212021
Washington University in St. LouisAcademic/Hospital2212023
Baylor UniversityAcademic/Hospital1112022
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealAcademic/Hospital1112024
Chulalongkorn UniversityAcademic/Hospital1112023
ClinilabsFor profit1012011
Duke UniversityAcademic/Hospital1012024
Flinders UniversityAcademic/Hospital1112025
Government of CanadaGovernment1112023
Government of ThailandGovernment1112024
Kurume UniversityAcademic/Hospital1112021
Laval UniversityAcademic/Hospital1112025
Mebix IncFor profit1012021
National Institute on Aging (NIA)Government1012024
30 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
EisaiFor profitMKTGDec 20, 2019
EisaiFor profitNDADec 20, 2019
Sarepta TherapeuticsFor profitNDA2Dec 20, 2019