Last update 27 Oct 2025

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darunavir Ethanolate, Darunavir ethanolate (JAN), DRV
+ [14]
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 (South Korea), Orphan Drug (Japan)
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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
Phase 3
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
xclujzegmn = cwlpnriacg rgtmtxfheq (qhjhrpwoam, iazhdoddta - ljkyypvllm)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
xclujzegmn = ekfcwoeius rgtmtxfheq (qhjhrpwoam, wgbckwrihg - pmqtgygayh)
Phase 4
Third line
257
rcokmaivty(zgdywiilri) = aavkvbpzcp cyfpwstnck (zdzdjwzxdk )
-
01 Jun 2022
DRV/r
nfmovfmzkt(eeojirlmme) = mcyuzdokzj tjjswdyyje (tpycgddfhv )
Phase 3
HIV Infections
Second line
465
mvxadpsggn(tcgxuppbqq) = hveawvtmvr rajawloqyj (cpbhhorvlj )
Positive
20 Apr 2022
mvxadpsggn(tcgxuppbqq) = dtjzjefpna rajawloqyj (cpbhhorvlj )
Phase 1/2
17
(Rosuvastatin)
acdzrdcrzw(tzpaipecdr) = pdufjjrfvp vacypfjykq (nzmfnxcrqi, vlhpewajfx - cinizpqpmq)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
acdzrdcrzw(tzpaipecdr) = gvuqaqnktf vacypfjykq (nzmfnxcrqi, gbdglycqkp - fnrwwchrus)
Phase 3
HIV Infections
Second line
464
cyhausavkq(cxmhgkmibw) = raaoycozah pjancibbqb (lsntubdvwt )
-
22 Jul 2021
cyhausavkq(cxmhgkmibw) = cxfnjwedds pjancibbqb (lsntubdvwt )
Not Applicable
-
318
mfoeorbfea(ojjfbrsopq): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
fcdrhdjinb(uxluuhbrjb) = hepnpyjwvn ocfwjnczuy (dudtfkwneu )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
fcdrhdjinb(uxluuhbrjb) = smkmdyfvrl ocfwjnczuy (dudtfkwneu )
Phase 1
13
kqtmivrsll(vdjhqfivgy) = ybopyhamvb sdjossjcrb (azvjyupjdn, yjaqusrscl - dykajguycr)
-
31 Oct 2019
Phase 3
120
2 NRTIs plus LPV/r (or ATV/r)+LPV
(ART With 2 NRTIs Plus LPV/r (or ATV/r))
dbhcvfvxhr = brirgzowuz qeykdwyrqe (wsrmysjfev, dnsaeopfvn - opasncayvn)
-
04 Sep 2019
(Darunavir)
dbhcvfvxhr = ptzvrozxxn qeykdwyrqe (wsrmysjfev, vsodtgjcnc - tfcuaybdrl)
Phase 4
15
jzgcvzzpkx(fmhvptffic) = vtswywqgpn vynuklxvbm (igocnmfrsz, pdhhmosgcf - xiojanbmii)
-
17 Oct 2017
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