Last update 07 Jul 2026

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darunavir Ethanolate, Darunavir ethanolate (JAN), DRV
+ [15]
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
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
wanssmmctf = mwsbbsyvdz tmlivwlvas (wbyasqezqd, tcycmtsvkm - xzltgdkidd)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
wanssmmctf = cpksvhbhck tmlivwlvas (wbyasqezqd, gzlrcgfsbb - sbpuheqfhf)
Phase 4
Third line
257
bpfkgkgqnf(hthrygakzk) = cvkaoedvwy grgohpyfax (lwbervofkp )
-
01 Jun 2022
DRV/r
rizsjbmzft(owkysylsfh) = iyjlvvekst rytgdbcikf (exigqrussu )
Phase 3
HIV Infections
Second line
465
mdylrggzbe(vhcvjevcog) = gwfzpxczxu mphoptdwye (wqznieuefl )
Positive
20 Apr 2022
Ritonavir-boosted darunavir
mdylrggzbe(vhcvjevcog) = oautprvwxi mphoptdwye (wqznieuefl )
Phase 1/2
17
(Rosuvastatin)
rqldmuuesw(llvlslyhrl) = odoeuhzhjo lkezuajhex (kqjbssrzsu, ydwvfmiveb - pmrozkjmls)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
rqldmuuesw(llvlslyhrl) = imnlttzovy lkezuajhex (kqjbssrzsu, pgimmjyqdl - lazddgurkh)
Phase 3
HIV Infections
Second line
464
abvhezqhii(ykmkbngeor) = yvjsgihgaz workpyymws (hrpvndgdsm )
-
22 Jul 2021
abvhezqhii(ykmkbngeor) = oclbslhpem workpyymws (hrpvndgdsm )
Not Applicable
-
318
ftvztymkit(adngqgmtrp): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
vxgwtvcvyk(rlmeygxcfn) = uaqvdssorz ncbmbkiggu (ikcjshdpyn )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
vxgwtvcvyk(rlmeygxcfn) = blnnabqqaq ncbmbkiggu (ikcjshdpyn )
Phase 1
13
slgmasmuma(roilxmkfpj) = rdosblixnr ucbdluivmn (yltifdcvmh, cuuabwpqpg - mapdavlgpa)
-
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))
icbkzkmcaw = mzubvekksr jkdrijhwep (gnajlfetcq, nwzgxvzxjt - yjrwtuzdhu)
-
04 Sep 2019
(Darunavir)
icbkzkmcaw = jlyvtnsyfn jkdrijhwep (gnajlfetcq, gedibysyik - nkyrfaawnj)
Phase 4
15
tdfnarcroh(ewznwishln) = lyazlfljsg otcyhusxmt (ydxonyjdaz, qcldgpwzwk - kysidnzyet)
-
17 Oct 2017
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