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cobicistat

Trade name: stribild

Small moleculeapprovedFast Track FDA

Approved

Aug 27, 2012

Cobicistat (GS-9350) is a potent, and selective inhibitor of human cytochrome P450 3A (CYP3A) enzymes. Cobicistat is a pharmacokinetic booster of several antiretrovirals. TYBOST (cobicistat) is indicated to increase systemic exposure of atazanavir or darunavir in combination with other antiretroviral agents in the treatment of HIV-1 infection. — NCATS

Clinical trial activity

127 trials · 87 clinical orgs · 5 marketing orgs

Phase 1
40
Phase 2
44
Phase 3
40
Phase 4
33

Earliest trial started Jan 1, 2002 (NCT00537966)

Timeline

2000s

  1. Jan 1, 2009

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2009

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Johnson and Johnson — Earliest Phase 1 Sponsor(trial)

  2. Aug 27, 2012

    Gilead Sciences — Earliest FDA Approval

  3. Aug 27, 2012

    Gilead Sciences — NDA Organization

  4. Jan 29, 2015

    Bristol-Myers Squibb — Marketing Organization

  5. Jan 29, 2015

    Johnson and Johnson — Marketing Organization

  6. Jan 29, 2015

    Bristol-Myers — NDA Secondary Org

  7. Jan 29, 2015

    Bristol-Myers Squibb — NDA Secondary Org

  8. Jan 29, 2015

    Johnson and Johnson — NDA Secondary Org

2020s

  1. Feb 7, 2024

    Mylan — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFast trackAug 27, 2012

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C1=NC(CN(C)C(=O)N[C@@H](CCN2CCOCC2)C(=O)N[C@H](CC[C@H](CC3=CC=CC=C3)NC(=O)OCC4=CN=CS4)CC5=CC=CC=C5)=CS1
Mol. weight
776.023 g/mol
Lipinski Ro5
2 violation(s)
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

  • 1,3-thiazol-5-ylmethyl [(2r,5r)-5-{[(2s)-2-({[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)carbamoyl}amino)-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate
  • 1,3-thiazol-5-ylmethyl [(2r,5r)-5-{[(2s)-2-({[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)carbamoyl}amino)-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate
  • atazanavir sulfate / cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat
  • cobicistat on silicon dioxide
  • combicistat
  • darunavir / cobicistat
  • darunavir / cobicistat / emtricitabine / tenofovir alafenamide
  • elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
  • elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate
  • gs 9350
  • stribild
  • stribild
  • stribild
  • tybost
  • tybost
  • tybost
  • tybost
  • tybost
  • tybost

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06787976Phase 4Apr 19, 2025Instituto Mexicano del Seguro Social
NCT06726382Phase 1Dec 9, 2024University of Helsinki
NCT06337032Phase 4Aug 27, 2024Gilead Sciences
NCT06385119Phase 1Apr 24, 2024Novellus Therapeutics
NCT06014489Phase 2Dec 31, 2023HOVON - Dutch Haemato-Oncology Association
NCT05748093Phase 4Jun 1, 2023Maastricht University
NCT05494866Phase 1Dec 7, 2022German Cancer Research Center, University of Heidelberg
NCT05503797Phase 2Nov 1, 2022Novellus Therapeutics
NCT05692570Phase 1Sep 9, 2022Pyramid Biosciences
NCT05458102Phase 1Aug 19, 2022Gilead Sciences
NCT05197075Phase 1Aug 3, 2022Johnson and Johnson
NCT05463783Phase 4Jul 31, 2022East Carolina University, Janssen Pharmaceutica NV
NCT05378906Phase 1Jun 7, 2022—
NCT05236738Phase 1May 13, 2022Bristol-Myers Squibb
NCT05078671Phase 4Oct 15, 2021Radboud University
NCT04718805Phase 1Jan 25, 2021Janssen Pharmaceutica NV
NCT04661397Phase 1Dec 21, 2020Janssen Pharmaceutica NV
NCT04518228Phase 4Oct 15, 2020Boston University, Gilead Sciences, Merck, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), ViiV Healthcare
NCT04653194Phase 3Sep 30, 2020Chelsea and Westminster Hospital NHS Foundation Trust, Gilead Sciences, Imperial College London, University of London
NCT04442737Phase 4Jul 1, 2020Janssen Pharmaceutica NV
Showing 20 of 127 trials
Page 1 / 7

Organizations

Research & Development (87)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit513452009
Janssen Pharmaceutica NVFor profit20732009
Johnson and JohnsonFor profit12932009
Bristol-Myers SquibbFor profit6412013
National Institutes of Health (NIH)Government5322003
ViiV HealthcareFor profit5222014
MerckFor profit4122015
National Institute of Allergy and Infectious Diseases (NIAID)Government4232003
St Stephens Aids TrustAcademic/Hospital4422014
Fundacio Lluita Contra la SIDAAcademic/Hospital3322016
Radboud UniversityAcademic/Hospital3322015
University of BarcelonaAcademic/Hospital3322015
Boston UniversityAcademic/Hospital2012003
Centers for Disease Control and Prevention (CDC)Government2012017
Emory UniversityAcademic/Hospital2212017
Fundacion SEIMC-GESIDAAcademic/Hospital2212017
GlaxoSmithKlineFor profit2122014
Harvard UniversityAcademic/Hospital2112014
Maastricht UniversityAcademic/Hospital2222019
Novellus TherapeuticsFor profit2222022
87 organizations
Page 1 / 5

Marketing (7)

OrganizationOrg typeRelationshipDate
Bristol-MyersFor profitNDA2Jan 29, 2015
Bristol-Myers SquibbFor profitMKTGJan 29, 2015
Bristol-Myers SquibbFor profitNDA2Jan 29, 2015
Gilead SciencesFor profitNDAAug 27, 2012
Johnson and JohnsonFor profitMKTGJan 29, 2015
Johnson and JohnsonFor profitNDA2Jan 29, 2015
MylanFor profitMKTGFeb 7, 2024