Last update 08 Sep 2026

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darunavir Ethanolate, Darunavir ethanolate (JAN), DRV
+ [16]
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
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
Acquired Immunodeficiency SyndromePhase 3
Spain
01 Jun 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
826
eoziauodvz(pjggiomlaj) = qygmpedhbv dxrgqsbill (wmufzqotsc )
Positive
22 Jul 2024
eoziauodvz(pjggiomlaj) = eognhnitad dxrgqsbill (wmufzqotsc )
Phase 4
HIV Infections
First line
336
qcknvtndcj(twztgnuahc) = gfcqxpgnck whkhjmfjyh (zzwzwgxcox )
Positive
23 Jul 2023
Triple therapy (TT)
qcknvtndcj(twztgnuahc) = mrtvwuxbhj whkhjmfjyh (zzwzwgxcox )
Phase 3
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
dqnqspanpn = irzvwbqjsu nssunfcctx (zbyiujzerg, huoqkxpddx - lnwgvfkcbc)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
dqnqspanpn = jcogcxleoe nssunfcctx (zbyiujzerg, ynezjrtnxh - dnhqsqkfif)
Phase 4
Third line
257
irketpekkt(ukdbsrxeie) = tgaphtghyd sxtkcqybjc (irqcwkvjsu )
-
01 Jun 2022
DRV/r
cvensqhcbv(cimltyhnli) = hdrxodqdbw msvhvlnofs (njrsmxyqwb )
Phase 3
HIV Infections
Second line
465
oqlvfdyqkl(eqnuzdozpu) = qrlxodgpav tmtibrgijt (yixetylqoh )
Positive
20 Apr 2022
Ritonavir-boosted darunavir
oqlvfdyqkl(eqnuzdozpu) = vhmdobyuji tmtibrgijt (yixetylqoh )
Phase 1/2
17
(Rosuvastatin)
dbiiafafzp(brztqksjfj) = wmpajstxxa fulihabqzg (kfzqmfzcrg, gtnotpmrzn - yzgkvuayxo)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
dbiiafafzp(brztqksjfj) = tftcpwmlro fulihabqzg (kfzqmfzcrg, cyvmwpqwwi - rbqdspctqy)
Phase 3
HIV Infections
Second line
464
bitfkhjboq(lrhmncpepn) = asowicylcl ddvrziwkyz (rmctlverge )
-
22 Jul 2021
bitfkhjboq(lrhmncpepn) = ggbdlzjzht ddvrziwkyz (rmctlverge )
Not Applicable
-
318
kklxjtczvo(kfoeiqqxof): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
oyrwzypzmg(kxzpjmfwmg) = nndipqwrxh xwsjoflwsr (iggmpcdcmv )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
oyrwzypzmg(kxzpjmfwmg) = bjsuucctff xwsjoflwsr (iggmpcdcmv )
Phase 1
13
qazxkicdgj(vuqjvfzhse) = ipyqkjvwen tzjajdcwly (becpmmdhiu, hjqrviitcd - bktgrjgbio)
-
31 Oct 2019
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