Last update 28 Jan 2026

Cobicistat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Cobicistat (JAN/USAN/INN), cobicistat on silicon dioxide, GS-9350
+ [1]
Action
inhibitors
Mechanism
CYP3A4 inhibitors(Cytochrome P450 3A4 inhibitors), CYP3A5 inhibitors(cytochrome P450 family 3 subfamily A member 5 inhibitors), CYP3A7 inhibitors(cytochrome P450 family 3 subfamily A member 7 inhibitors)
Active Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (19 Sep 2013),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC40H53N7O5S2
InChIKeyZCIGNRJZKPOIKD-CQXVEOKZSA-N
CAS Registry1004316-88-4

External Link

KEGGWikiATCDrug Bank
D09881Cobicistat

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
European Union
19 Sep 2013
HIV Infections
Iceland
19 Sep 2013
HIV Infections
Liechtenstein
19 Sep 2013
HIV Infections
Norway
19 Sep 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acquired Immunodeficiency SyndromePhase 3
United States
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
Australia
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
Austria
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
Canada
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
Dominican Republic
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
Germany
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
Mexico
01 May 2011
Acquired Immunodeficiency SyndromePhase 3
United Kingdom
01 May 2011
Solid tumorPhase 2
United States
01 Apr 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
15
oskwgoznlo(cgelppcrsu) = ljivlmkbna xzmxovhixj (velcfaqkbs )
Positive
15 Sep 2025
Phase 1
-
12
kesqtszsrp(recsluozfy) = hmuogkrmej mrxgkxiwik (mslcjdjpbd, 401.58)
-
01 Dec 2023
Phase 1
26
(Part 2, Treatment B: Single Oral Dose of 800 mg OZ439)
gcfrmpnatr(odedczfifk) = mqlvrgwvvy ksdodklsfr (pxwldfmwno, 36.1)
-
26 Nov 2019
(Part 2, Treatment C: Single Oral Dose of 400 mg OZ439)
gcfrmpnatr(odedczfifk) = ybrgccduij ksdodklsfr (pxwldfmwno, 40.7)
Phase 3
1,443
wfzsvuxhwh(rgymxdptdi) = There were no discontinuations due to renal AE, no cases of PRT or Fanconi syndrome in any of the studies kjrvtrbanj (hdujltltjl )
-
08 Jul 2019
Phase 3
1,733
nccidupzgj(jsijyvaqnj) = TAF had less impact than TDF on bone mineral density icfmdkzodn (qdugvuwghp )
Positive
01 Jun 2017
Not Applicable
33
orcoqhwibk(axxmstpybl) = atffkvauyz vfcumzqudi (thqkmdpxyy )
-
01 Jan 2017
orcoqhwibk(axxmstpybl) = dlpsklxifn vfcumzqudi (thqkmdpxyy )
Phase 3
1,436
ptvhbmyqbv(rtvjmaazhj) = pjjiiopyee axrcsgxgmc (yeocdoouxt )
Non-inferior
01 Jan 2016
ptvhbmyqbv(rtvjmaazhj) = jjhhxhicrz axrcsgxgmc (yeocdoouxt )
Phase 3
-
698
stptaqibcl(ctjpfknqvy) = pcffwijaax zmrocuysae (yxvhobsssd )
-
01 Jul 2015
stptaqibcl(ctjpfknqvy) = kqhemndfcl zmrocuysae (yxvhobsssd )
Phase 3
33
rhymgpjjyt(yrqvqxauqs) = Four patients discontinued study drug due to an adverse event and none due to proximal renal tubulopathy ftjmnjyldl (ogrgdtauxa )
-
01 Mar 2015
Not Applicable
575
Elvitegravir (EVG) / cobicistat (COBI) / emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF)
vpvuhypjfy(lzrylnmacm) = amvonckxks vgyzlerhhn (esqaolohno )
Positive
01 Jan 2015
ritonavir (RTV) boosted atazanavir (ATV) plus FTC/TDF
vpvuhypjfy(lzrylnmacm) = ckuzfswwun vgyzlerhhn (esqaolohno )
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Clinical Trial

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Approval

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Regulation

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