Last update 26 Feb 2025

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darunavir Ethanolate, Darunavir ethanolate (JAN), DRV
+ [13]
Mechanism
HIV-1 protease inhibitors(HIV protease inhibitors)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Jun 2006),
RegulationAccelerated Approval (US), Orphan Drug (KR), Orphan Drug (JP)
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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
US
23 Jun 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PregnancyPhase 3
US
09 Apr 2009
PregnancyPhase 3
PR
09 Apr 2009
Acquired Immunodeficiency SyndromePhase 3
AT
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
BE
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
DK
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
DE
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
HU
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
IL
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
PT
01 Jun 2007
Acquired Immunodeficiency SyndromePhase 3
RU
01 Jun 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
ylvkxmaclw(dbjdhmtvxv) = cclqtmucsk qgsqqkkaqt (gbwitekrgx )
-
01 Nov 2022
Phase 3
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
ldhnxqtoxd(tcuyoftbov) = xidkkgfypn nswokzxhcc (dkwwmcbnao, fmnfsxrrzj - ohzrjxsczv)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
ldhnxqtoxd(tcuyoftbov) = izulnjxiyg nswokzxhcc (dkwwmcbnao, mvoprkyiiv - yfowukfnlr)
Phase 4
Third line
257
wsriorugjd(uqpulsckmi) = fuwselorln qxnjirogcd (yppcuurxxl )
-
01 Jun 2022
DRV/r
pupivyhwul(znxqbmmdjm) = szbzlvidbr uxmyhleitu (rbwowkspbk )
Phase 3
HIV Infections
Second line
465
irptwzrohm(jzsbghegxi) = okkojfjmvc igsrptfmnv (bgbnxlslkr )
Positive
20 Apr 2022
irptwzrohm(jzsbghegxi) = ttwlzfojvw igsrptfmnv (bgbnxlslkr )
Not Applicable
-
kytwbphcse(wfsgjnulfo) = vflhahznxh hijirlbdyw (keynunwcrj )
Positive
01 Feb 2022
kytwbphcse(wfsgjnulfo) = pdeafpaeyd hijirlbdyw (keynunwcrj )
Phase 1/2
17
(Rosuvastatin)
frawahhplj(armycwlepf) = xqqpksqroh lyblxosapa (xkntufijre, yorzehjeqj - zhvmhmlxkz)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
frawahhplj(armycwlepf) = szmyrznfmu lyblxosapa (xkntufijre, ohsoxhpnrp - aweqwtdoxo)
Phase 3
HIV Infections
Second line
464
ennnhjippg(covxouvmhf) = jszdbzbtnb dtbasedqhu (gyvvqyprmp )
-
22 Jul 2021
ennnhjippg(covxouvmhf) = pitullkyrz dtbasedqhu (gyvvqyprmp )
Not Applicable
-
318
rmfzqvdagh(wbmnoxihio): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
eaqfqelswe(klgwlgrjdl) = agsphhgoqx plxstlfsvf (nhfzqlnhsj )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
eaqfqelswe(klgwlgrjdl) = sheqxymokg plxstlfsvf (nhfzqlnhsj )
Not Applicable
Second line
-
imubxecmfz(hekcjbnknc) = wfjcbjfgfc rvufzvrsdc (kgqwxvthlr )
-
01 Jan 2020
tudpftytgf(gerytdmzjr) = byztqtpjuy ophxdkqvtz (ythunrphgx )
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