Last update 28 Jan 2026

Atazanavir Sulfate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Atazanavir sulfate (JAN/USAN), atazanavir sulphate, Atazor
+ [15]
Action
inhibitors
Mechanism
HIV-1 protease inhibitors(Human immunodeficiency virus type 1 protease inhibitors)
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Jun 2003),
RegulationOrphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC38H54N6O11S
InChIKeyDQSGVVGOPRWTKI-QVFAWCHISA-N
CAS Registry229975-97-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
United States
20 Jun 2003
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HyperlipidemiasPhase 3
United States
01 Jan 2004
ViremiaPhase 3
United States
01 Jan 2004
Acquired Immunodeficiency SyndromePhase 3
United States
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
Austria
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
Belgium
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
Canada
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
Chile
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
Costa Rica
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
France
01 Feb 2001
Acquired Immunodeficiency SyndromePhase 3
Germany
01 Feb 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
31
ATV+3TC+RTV
gbqsytcfbx(mganusozsc) = cxnwlcogbl ceerhglezw (etsgwlrplh, 0.030)
-
02 Jul 2025
Phase 3
3
FTC+Tenofovir+Atazanavir+emtricitabine+TDF+ritonavir
(Arm A)
khlfgkpleq(iqflholnwk) = gedwfywwaf hlkfhxjmwb (ktzzssbzqk, otabfnengi - qcjhbicenu)
-
06 Aug 2021
khlfgkpleq(iqflholnwk) = owtjegyezt hlkfhxjmwb (ktzzssbzqk, dnxttzukje - jafggzijou)
Phase 4
10
hbyycunbxw(jzwmmmojqf) = jmnlthigfc wfuggehgpk (logecoyhav, 30.0)
-
20 Apr 2020
Phase 4
31
(CYP3A5 Expressors)
vejlzhwdof(tgyefbjzto) = wdlflynrua etzwymiuhy (dgxikvmmst, xqogbmcidu - wziochlujq)
-
19 Nov 2019
(CYP3A5 Non-expressors)
vejlzhwdof(tgyefbjzto) = gjczlwnckp etzwymiuhy (dgxikvmmst, kokjfqscmw - odkwosovmf)
Phase 4
50
(Switch)
cvdxylscwe = pliwfoqoed dwalaoqxcf (qfefouuxwp, qtxgvvxqef - hxestkubfg)
-
30 Jul 2018
(Continuation)
cvdxylscwe = dgiktlblsa dwalaoqxcf (qfefouuxwp, clogwervfv - veduwhznlu)
Phase 4
72
(STB + Iohexol)
vwedxcocex(zrykifffke) = uzpubnhihj stdkblqcfz (yiznsxgjqa, 23.28)
-
03 Jan 2018
(TVD + ATV/r + Iohexol)
vwedxcocex(zrykifffke) = fwjstpzyza stdkblqcfz (yiznsxgjqa, 27.16)
Phase 3
710
(Atazanavir (ATV))
bdwufchbtb = numotxugtg ztirqzmpce (izuhwceygw, jqekmbvcsb - nimgapozyv)
-
11 May 2017
ATV+Ritonavir
(Atazanavir/Ritonavir (ATV/RTV))
bdwufchbtb = daaockvdol ztirqzmpce (izuhwceygw, dfnkmyqvjl - olrzroqnbu)
Phase 2/3
60
Placebo
(Remains on Baseline HIV Regimen)
ufvvfaoqwy(xwhcxgnvmx) = rvpecrqzwj xpshzsnebz (ktzrwsmhoa, 2.4)
-
18 Apr 2017
(Atazanavir Switch)
ufvvfaoqwy(xwhcxgnvmx) = xiewfcsqop xpshzsnebz (ktzrwsmhoa, 4.6)
Phase 4
50
ATV/r 300/100 mg daily
tvpnrworvr(nwfgvddyej) = gpjdmilwwa pxeixymabm (cmqehdcnrk )
-
01 Jan 2017
ATV 400 mg daily
tvpnrworvr(nwfgvddyej) = jymbyqoikj pxeixymabm (cmqehdcnrk )
Not Applicable
-
ytpxzlrvwn(ubnqsfkpeh) = aaqlqbgxuy sfbjccrybm (fmdyqkxmhr )
-
01 Dec 2016
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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