CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

cabotegravir

Trade name: Vocabria

Small moleculeapprovedFast Track FDA

Approved

Jan 21, 2021

Cabotegravir, sold under the brand name Vocabria among others, is an antiretroviral medication used for the treatment and prevention of HIV/AIDS. It is available in the form of tablets and as an intramuscular injection, as well as in an injectable combination with rilpivirine under the brand name Cabenuva. — Wikipedia

Clinical trial activity

83 trials · 74 clinical orgs · 1 marketing orgs

Phase 1
30
Phase 2
40
Phase 3
24
Phase 4
13

Earliest trial started Feb 1, 2008 (NCT00659191)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2009

    ViiV Healthcare — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2016

    ViiV Healthcare — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 21, 2021

    ViiV Healthcare — Earliest FDA Approval

  2. Jan 21, 2021

    ViiV Healthcare — NDA Secondary Org

  3. Jan 21, 2021

    ViiV Healthcare — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • cabenuva

    with rilpivirine

    Also known as cabotegravir and rilpivirine (co-packaged), cabotegravir and rilpivirine -extended release injectable suspension

Approval history

  • approvedPriority reviewFast trackJan 21, 2021

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1CO[C@@H]2Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N12
Mol. weight
405.36 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • cabotegravir
  • cabotegravir
  • cabotegravir
  • cabotegravir
  • cabotegravir
  • cabotegravir sodium
  • cabotegravir sodium
  • gsk1265744
  • gsk1265744
  • gsk1265744
  • gsk1265744a
  • gsk1265744a
  • gsk1265744b
  • gsk1265744b
  • gsk1265744b
  • gsk744
  • gsk744
  • gsk744
  • n-((2,4-difluorophenyl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide
  • s-265744b
  • s-265744b

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07275606Phase 1/Phase 2 (Phase 2)Mar 17, 2026ViiV Healthcare
NCT07199335Phase 4Nov 30, 2025Fenway Community Health, Harvard University, ViiV Healthcare
NCT06854029Phase 4Nov 30, 2025Brown University, Duke University, Friends Research Institute, Inc., National Institute on Drug Abuse (NIDA), University of Arkansas
NCT06970223Phase 1Apr 22, 2025ViiV Healthcare
NCT06646562Phase 4Mar 3, 2025Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, ViiV Healthcare
NCT06501781N/AJan 31, 2025University of Maryland
NCT06741397Phase 2Dec 20, 2024ViiV Healthcare
NCT06694805Phase 3Dec 2, 2024ViiV Healthcare
NCT06336434Phase 1/Phase 2 (Phase 2)Sep 24, 2024National Institute of Allergy and Infectious Diseases (NIAID)
NCT06468995Phase 3Sep 1, 2024GlaxoSmithKline, Vita-Salute University of Milano. Italy
NCT06474364Phase 4Aug 5, 2024Baylor University, Infectious Disease Institute, Kampala, Uganda, Johns Hopkins University, University of California, San Francisco
NCT06411223Phase 2Aug 1, 2024ViiV Healthcare, Yale University
NCT06507059Phase 3Jul 19, 2024Chang Gung University, Taoyuan General Hospital
NCT06158126Phase 4Apr 17, 2024Government of Malawi, National Institutes of Health (NIH), University of North Carolina at Chapel Hill
NCT06133686Phase 3Apr 1, 2024Africa Health Research Institute, Assistance Publique - Hôpitaux de Paris, Desmond Tutu HIV Foundation, Government of Uganda, Medical Research Council-UVRI Uganda Research Unit on AIDS, University of London, Wits Health Consortium (Pty) Ltd
NCT06273943Phase 3Apr 1, 2024Government of France, University of Paris
NCT06250504Phase 3Feb 27, 2024Africa Health Research Institute
NCT06134362Phase 3Jan 5, 2024GlaxoSmithKline, PPD, ViiV Healthcare
NCT06138600Phase 3Nov 1, 2023Bill and Melinda Gates Foundation, University of the Witwatersrand, ViiV Healthcare, Wits Health Consortium (Pty) Ltd
NCT05986084Phase 4Oct 31, 2023Botswana Harvard Aids Institute, Harvard University, National Institutes of Health (NIH), ViiV Healthcare
Showing 20 of 83 trials
Page 1 / 5

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ViiV HealthcareFor profit584752008
GlaxoSmithKlineFor profit23232008
National Institute of Allergy and Infectious Diseases (NIAID)Government131142015
Janssen Pharmaceutica NVFor profit9032014
National Institutes of Health (NIH)Government4022020
Africa Health Research InstituteAcademic/Hospital3112022
Johnson and JohnsonFor profit3012017
Medical Research Council-UVRI Uganda Research Unit on AIDSAcademic/Hospital3212022
National Institute of Mental Health (NIMH)Government3022020
PPDFor profit3022018
ShionogiFor profit3022008
Boston UniversityAcademic/Hospital2112020
Gilead SciencesFor profit2022016
Harvard UniversityAcademic/Hospital2212023
Infectious Disease Institute, Kampala, UgandaAcademic/Hospital2012022
Rush UniversityAcademic/Hospital2012020
University of Alabama, BirminghamAcademic/Hospital2022018
University of California, Los AngelesAcademic/Hospital2022015
University of California, San FranciscoAcademic/Hospital2112022
University of LondonAcademic/Hospital2112022
74 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
ViiV HealthcareFor profitNDA2Jan 21, 2021
ViiV HealthcareFor profitNDAJan 21, 2021