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nabilone

Trade name: cesamet

Small moleculeapproved

Approved

Dec 26, 1985

Nabilone is a synthetic cannabinoid approved under the brand name cesamet for treatment of severe nausea and vomiting associated with cancer chemotherapy. Nabilone is an orally active which, like other cannabinoids, has complex effects on the central nervous system (CNS). It has been suggested that the antiemetic effect of nabilone is caused by interaction with the cannabinoid receptor system, i.e. the CB (1) receptor, which has been discovered in neural tissues. — NCATS

Clinical trial activity

32 trials · 26 clinical orgs · 3 marketing orgs

Phase 1
5
Phase 2
18
Phase 3
8
Phase 4
6

Earliest trial started Dec 1, 2005 (NCT00384410)

Timeline

1980s

  1. Dec 26, 1985

    Earliest FDA Approval

  2. Dec 26, 1985

    Bausch Health Companies — Marketing Organization

  3. Dec 26, 1985

    Mylan — NDA Secondary Org

  4. Dec 26, 1985

    Bausch Health Companies — NDA Secondary Org

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 26, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCC(C)(C)C1=CC(O)=C2[C@@H]3CC(=O)CC[C@H]3C(C)(C)OC2=C1
Mol. weight
372.5408 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a- hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo(b,d)pyran-9-one
  • cesamet
  • cesamet
  • cesamet
  • cesamet
  • cesamet
  • cesemat
  • cpd 109514
  • cpd 109514
  • cpd-109514
  • cpd-109514
  • lilly 109514
  • lilly brand of nabilone
  • ly 109514
  • ly 109514
  • ly-109514
  • nabilon
  • nabilon
  • nabilona
  • nabilona
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone
  • nabilone, (6ar-trans)-isomer
  • nabilone, (6as-trans)-isomer
  • nabilone, (cis-(+-))-isomer
  • nabilone, (trans-(+-))-isomer
  • nabilonum
  • nabilonum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05885685Phase 4Jun 30, 2023University of Toronto
NCT05742698Phase 2Mar 7, 2023Alzheimer’s Drug Discovery Foundation, McGill University
NCT05494437Phase 2Oct 27, 2022PleoPharma, Inc.
NCT05180968Phase 3Jun 30, 2022McMaster University, University of Manitoba
NCT05273320Phase 1Mar 17, 2022University of Toronto
NCT04880278Phase 1/Phase 2 (Phase 2)Nov 20, 2021Columbia University, National Institute of Mental Health (NIMH)
NCT04801641Phase 2May 31, 2021University of Toronto
NCT04807829Phase 2Apr 30, 2021University of Texas at Houston
NCT04516057Phase 3Oct 31, 2020Alzheimer’s Drug Discovery Foundation, University of Toronto, Weston Brain Institute
NCT03422861N/AAug 31, 2018Icahn School of Medicine at Mount Sinai
NCT03773796Phase 3Aug 6, 2018Medical University Innsbruck
NCT03769896Phase 2Oct 3, 2017Medical University Innsbruck
NCT02911324Phase 1/Phase 2 (Phase 2)Sep 1, 2016Columbia University
NCT03251326Phase 1/Phase 2 (Phase 2)Oct 31, 2015Columbia University, National Institute on Drug Abuse (NIDA)
NCT02351882Phase 2/Phase 3 (Phase 3)Jan 1, 2015University of Toronto
NCT02802540Phase 2/Phase 3 (Phase 3)Dec 1, 2014Government of Mexico
NCT02115529Phase 2Apr 1, 2014University of Toronto
NCT01222468Phase 2Jun 1, 2012Canadian Paraplegic Association, Health Sciences Centre Foundation, Manitoba, The Manitoba Spinal Cord Injury Research Fund, University of Manitoba
NCT01517100Phase 1Jan 2, 2012National Institute on Aging (NIA)
NCT01347762Phase 2/Phase 3 (Phase 3)Jun 1, 2010Mclean Hospital, National Institute on Drug Abuse (NIDA)
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of TorontoAcademic/Hospital7742005
Bausch Health CompaniesFor profit6022005
University of ManitobaAcademic/Hospital6532006
Columbia UniversityAcademic/Hospital3312015
Nema ResearchFor profit3312006
Alzheimer’s Drug Discovery FoundationAcademic/Hospital2022020
McGill UniversityAcademic/Hospital2222006
Medical University InnsbruckAcademic/Hospital2222017
National Institute on Drug Abuse (NIDA)Government2022010
Canadian Paraplegic AssociationAcademic/Hospital1012012
Government of MexicoGovernment1112014
Health Sciences Centre Foundation, ManitobaAcademic/Hospital1012012
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112018
Mclean HospitalAcademic/Hospital1112010
McMaster UniversityAcademic/Hospital1012022
National Institute of Mental Health (NIMH)Government1012021
National Institute on Aging (NIA)Government1112012
PleoPharma, Inc.For profit1112022
The Manitoba Spinal Cord Injury Research FundAcademic/Hospital1012012
The Royal College of Physicians and Surgeons of CanadaAcademic/Hospital1012006
26 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitMKTGDec 26, 1985
Bausch Health CompaniesFor profitNDA2Dec 26, 1985
Eli LillyFor profitNDA—
MylanFor profitNDA2Dec 26, 1985