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suvorexant

Trade name: belsomra

Small moleculeapproved

Approved

Aug 13, 2014

Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R. It has been approved for the treatment of insomnia. The mechanism by which suvorexant exerts its therapeutic effect in insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system is a central promoter of wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive. — NCATS

Clinical trial activity

70 trials · 51 clinical orgs · 1 marketing orgs

Phase 1
16
Phase 2
27
Phase 3
7
Phase 4
24

Earliest trial started Jun 1, 2007 (NCT00484757)

Timeline

2000s

  1. Jan 1, 2008

    Merck — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2009

    Merck — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Merck — Earliest Phase 1 Sponsor(trial)

  2. Aug 13, 2014

    Merck — Earliest FDA Approval

  3. Aug 13, 2014

    Merck — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 13, 2014

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1CCN(CCN1C(=O)C2=CC(C)=CC=C2N3N=CC=N3)C4=NC5=C(O4)C=CC(Cl)=C5
Mol. weight
450.921 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

First in class

Sources

Also known as

  • (4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
  • [(7r)-4-(5-chlor-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl]methanon
  • [(7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl]methanone
  • [(7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl]methanone
  • [(7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-méthyl-1,4-diazépan-1-yl][5-méthyl-2-(2h-1,2,3-triazol-2-yl)phényl]méthanone
  • [(7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-méthyl-1,4-diazépan-1-yl][5-méthyl-2-(2h-1,2,3-triazol-2-yl)phényl]méthanone
  • [(7r)-4-(5-chlorobenzoxazol-2-yl)-7-methylhexahydro-1h-1,4-diazepin-1-yl][5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl]methanone
  • belsomra
  • belsomra
  • belsomra
  • belsomra
  • belsomra
  • methanone, ((7r)-4-(5-chloro-2-benzoxazolyl)hexahydro-7-methyl-1h-1,4-diazepin-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)-
  • mk4305
  • mk 4305
  • mk 4305
  • mk 4305
  • mk 4305
  • mk 4305
  • mk 4305
  • mk-4305
  • mk-4305
  • mk-4305
  • mk-4305
  • mk-4305
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant
  • suvorexant

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07214207Phase 2Nov 30, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), Ohio State University
NCT06788522Phase 4Oct 1, 2025Department of Veteran Affairs
NCT06854224Phase 2Apr 1, 2025Department of Veteran Affairs
NCT06679062Phase 2Feb 28, 2025Pharmacotherapies for Alcohol and Substance Abuse Consortium, University of California, Los Angeles, University of Texas at Houston
NCT06834386Phase 4Feb 26, 2025Mayo Clinic
NCT06655883Phase 3Dec 2, 2024Merck
NCT06484075Phase 1/Phase 2 (Phase 2)Nov 17, 2024National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT06584942Phase 4Nov 15, 2024Harvard University
NCT06444256Phase 2Jul 25, 2024University of Texas at Houston
NCT06326684Early Phase 1 (Phase 1)Jun 7, 2024National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Kentucky
NCT06162663Phase 4Jan 31, 2024Medical University of South Carolina, Merck
NCT05908526Phase 2Oct 9, 2023Merck, University of Maryland
NCT05829655Early Phase 1 (Phase 1)Aug 8, 2023Johns Hopkins University, National Institute on Drug Abuse (NIDA)
NCT05733286Phase 2Jun 28, 2023Duke University, Merck
NCT05823844Phase 4May 31, 2023Columbia University, Merck
NCT05711862Phase 2Mar 9, 2023University of Texas at Houston
NCT05546554Phase 2Jan 1, 2023National Institutes of Health (NIH), Stanford University
NCT05630781N/ADec 29, 2022National Institute on Drug Abuse (NIDA)
NCT05593653Phase 4Dec 1, 2022Harvard University
NCT05546515Phase 2Dec 1, 2022Johns Hopkins University
Showing 20 of 70 trials
Page 1 / 4

Organizations

Research & Development (51)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit241242008
Harvard UniversityAcademic/Hospital7712017
Department of Veteran AffairsGovernment5422016
Johns Hopkins UniversityAcademic/Hospital5522019
National Institute on Drug Abuse (NIDA)Government5132019
University of Texas at HoustonAcademic/Hospital5412016
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government4122020
Henry Ford Health SystemAcademic/Hospital3222016
Stanford UniversityAcademic/Hospital3222015
EvergreenHealthAcademic/Hospital2212016
Howard UniversityAcademic/Hospital2212016
Ohio State UniversityAcademic/Hospital2222022
University of California, San FranciscoAcademic/Hospital2222016
University of KentuckyAcademic/Hospital2212019
Washington University in St. LouisAcademic/Hospital2222016
Augusta UniversityAcademic/Hospital1012016
Booth Gardner Parkinson's Care CenterAcademic/Hospital1012016
Burdick, Daniel, M.D.Academic/Hospital1012016
Columbia UniversityAcademic/Hospital1112023
Duke UniversityAcademic/Hospital1112023
51 organizations
Page 1 / 3

Marketing (1)

OrganizationOrg typeRelationshipDate
MerckFor profitNDAAug 13, 2014