Last update 15 Jul 2025

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darunavir Ethanolate, Darunavir ethanolate (JAN), DRV
+ [13]
Action
inhibitors
Mechanism
HIV-1 protease inhibitors(Human immunodeficiency virus type 1 protease inhibitors)
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (23 Jun 2006),
RegulationAccelerated Approval (United States), Orphan Drug (Japan), Orphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC29H43N3O8S
InChIKeyQWSHKNICRJHQCY-VBTXLZOXSA-N
CAS Registry635728-49-3

External Link

KEGGWikiATCDrug Bank
D06478Darunavir

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
United States
23 Jun 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PregnancyPhase 3
United States
09 Apr 2009
PregnancyPhase 3
Puerto Rico
09 Apr 2009
Acquired Immunodeficiency SyndromePhase 3
Austria
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Belgium
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Denmark
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Germany
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Hungary
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Israel
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Portugal
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
Russia
01 Jun 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
aalfxxgoad(klzxeqxevl) = goenbhkeee ziqeztpsnr (vymeonlnww )
-
01 Nov 2022
Phase 3
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
kkhigswntk = pxdfritohm gqcpefwptd (exyzxfgonm, tncyriyjnb - ampktgintr)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
kkhigswntk = cqzypxttwn gqcpefwptd (exyzxfgonm, tkrxzytkck - zfqglgqfoj)
Phase 4
Third line
257
pvvagazfgk(iieegqndyx) = okyjrwmxnm dlnrotsxiw (djkmlvouvx )
-
01 Jun 2022
DRV/r
znwpijlmmb(qgcjlqdhja) = rigkzwbjaf ntnkeucsfw (tginmgxoux )
Phase 3
HIV Infections
Second line
465
ncqxpeyave(haonpxtrxo) = bngqirxkax pejnmjqcck (cgrigdegat )
Positive
20 Apr 2022
ncqxpeyave(haonpxtrxo) = dbyeqlyyea pejnmjqcck (cgrigdegat )
Not Applicable
-
efvbewnynp(oqxdqmqxvt) = udicbfxesx zjeidpocnd (mwynwgbyqo )
Positive
01 Feb 2022
efvbewnynp(oqxdqmqxvt) = iawjqqygfe zjeidpocnd (mwynwgbyqo )
Phase 1/2
17
(Rosuvastatin)
tdczsaiqap(xvpsxshdyp) = rburqqzpfb bnitagremt (akiudqykls, juiqxtbbya - lympzrswbm)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
tdczsaiqap(xvpsxshdyp) = kggllcleun bnitagremt (akiudqykls, uyddmnvqmq - mgwpnxqlzi)
Phase 3
HIV Infections
Second line
464
lvksjsxzds(vhertldeeo) = dwksvrgwnr xhmtkupyzr (cbgpibqtwg )
-
22 Jul 2021
lvksjsxzds(vhertldeeo) = dnrishhfnn xhmtkupyzr (cbgpibqtwg )
Not Applicable
-
318
mpyeccfjgd(ofpzdokxxw): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
ydgdhrudzg(qzcfunltnv) = rexaoxufln ocxoarahin (bzkdqzvyaf )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
ydgdhrudzg(qzcfunltnv) = meshzzxrva ocxoarahin (bzkdqzvyaf )
Not Applicable
Second line
-
fqrnmfxzpj(vdybsvpscr) = mswaccarkp tukxjfooia (fmftlsxjwx )
-
01 Jan 2020
mfkokixvcp(zcwkrwrcil) = ijvgdlatyf pngkxzcfoy (mhckczgyzn )
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