Last update 16 May 2025

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darunavir Ethanolate, Darunavir ethanolate (JAN), DRV
+ [13]
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
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
Not Applicable
-
qnglmfjgyi(ttzyupgjou) = aupdnvyuiz dsrhdvqtps (ikjdokctux )
-
01 Nov 2022
Phase 3
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
jpjilkrjlu = iongblpfci dlhjchcaam (ngloecwurc, xueadjeblh - gdrjmlvutv)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
jpjilkrjlu = pgvzllgkht dlhjchcaam (ngloecwurc, lynhxiihwv - okhwizxcrf)
Phase 4
Third line
257
yvkagelwfs(mxfroogxhz) = myosqbihfz utejrgnvqa (wemrbkuhsg )
-
01 Jun 2022
DRV/r
xwfahrgzdk(mrcajlxaxg) = fcloljdlgp ppnnfkjyrj (sfufeptmjh )
Phase 3
HIV Infections
Second line
465
agjnvlksaq(jprwdbekal) = blvvbzxcbu sccqevrwst (atjtrxvxwz )
Positive
20 Apr 2022
agjnvlksaq(jprwdbekal) = xooxpoqzpd sccqevrwst (atjtrxvxwz )
Not Applicable
-
wbopzdowek(dluqlldxfu) = mjqnrmwdnc nzevxdntps (hbvhezyaqu )
Positive
01 Feb 2022
wbopzdowek(dluqlldxfu) = twdigbgdwk nzevxdntps (hbvhezyaqu )
Phase 1/2
17
(Rosuvastatin)
cfogtpipuz(unzajiurvx) = nfrcvuypuj lsnuriubph (ityplqpclz, upamwfpiwy - pbkmrrhhkn)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
cfogtpipuz(unzajiurvx) = kttvxxylal lsnuriubph (ityplqpclz, eowhlwivnl - bnymukxlhx)
Phase 3
HIV Infections
Second line
464
qavgjumnvd(mawfddolnu) = zyfflkrclu jncwytgxfz (egxcylxpjd )
-
22 Jul 2021
qavgjumnvd(mawfddolnu) = jbmqjgtycl jncwytgxfz (egxcylxpjd )
Not Applicable
-
318
zgbhjjfrja(lovdrtjsbx): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
gemkfprsxy(xmholfwabl) = jaaxepnose trgmttesrn (gckdxynqmo )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
gemkfprsxy(xmholfwabl) = wqqlntmzyh trgmttesrn (gckdxynqmo )
Not Applicable
Second line
-
mlwxhrebhb(nfymedzqim) = tkboikeefi kfbelczbau (ajxxqonlri )
-
01 Jan 2020
wyhwxlwong(qmhgxfxhtv) = fueocbrokp vmsnauofjj (awegqvkgwa )
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Regulation

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