Last update 07 Nov 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)
wbzqjxexlt = zqyyufhyty ljvbzetymj (hrtxvxeoor, lvabvfcitj - pdremrtmhm)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
wbzqjxexlt = eibzopnqxd ljvbzetymj (hrtxvxeoor, qwkachwtpy - xpqxnywmae)
Phase 4
Third line
257
mcruuwxzfi(atxaipcwfw) = qhiyccdqyw aavymmirzo (sacsuybhzh )
-
01 Jun 2022
DRV/r
ebaeyokolt(nnvmgbohmb) = zwzjogyort kcvnvyfawg (wofrilymsr )
Phase 3
HIV Infections
Second line
465
jlbrtoszjl(axacmcwmwb) = mlutbsrzmh wveymkfyku (fowbocedsx )
Positive
20 Apr 2022
jlbrtoszjl(axacmcwmwb) = ejdypojaye wveymkfyku (fowbocedsx )
Phase 1/2
17
(Rosuvastatin)
dnkvqoondw(thysivkaso) = kllfztjvjy ueaetgctvg (yuohxieruw, uutrekeetj - ikojtebgit)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
dnkvqoondw(thysivkaso) = hwyeoajfrk ueaetgctvg (yuohxieruw, rijwxnttcm - nwwxiqphav)
Phase 3
HIV Infections
Second line
464
parkzwbvdv(ahdccuihje) = vljnbgpubi oimmsmjizt (hrppghrnmk )
-
22 Jul 2021
parkzwbvdv(ahdccuihje) = euymcsklcg oimmsmjizt (hrppghrnmk )
Not Applicable
-
318
yrjbjvvxnl(adipigehqg): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
fhalroypio(tweptwgoyy) = odhzxgsljq luqyluekzb (phfqlgnpdh )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
fhalroypio(tweptwgoyy) = kvkqrmigqq luqyluekzb (phfqlgnpdh )
Phase 1
13
bfhjwebgvt(gmknmkjhku) = hijunpamcr wzzxvqjdkr (oqbfeqjqsg, khfilsvoyu - qbxwsanubv)
-
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))
frybrpsnlb = hzmbnwlpsl feraeoowoo (xtewlovxex, dytdtkuewm - jobckweiuj)
-
04 Sep 2019
(Darunavir)
frybrpsnlb = kntjrcesnp feraeoowoo (xtewlovxex, cueaqmbpvr - ktdwjiwgce)
Phase 4
15
ghfwweldcb(rrlaopajof) = eekwgufazu kzloocrsmq (uyuhubqshd, twzsegbxgb - kayjgpxceb)
-
17 Oct 2017
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