Last update 04 Nov 2024

Darunavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl N-((1S,2R)-1-benzyl-2-hydroxy-3-(N1-isobutylsulfanilamido)propyl)carbamate, (3R,3aS,6aR)-tetrahydro-2H-furo[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate, (3R,3aS,6aR)-tetrahydro-2H-furo[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-neopentylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate
+ [18]
Mechanism
HIV-1 protease inhibitors(HIV protease inhibitors)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Jun 2006),
RegulationOrphan Drug (KR), Accelerated Approval (US), Orphan Drug (JP)
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Structure

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
Phase 3
145
(Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)
jsyibpboqe(hagvhzurfl) = heqgtschoo rulttpylqu (qqqprnglnm, wbynmnouap - evukeveqrf)
-
31 Oct 2022
(Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))
jsyibpboqe(hagvhzurfl) = jbhahkrqsl rulttpylqu (qqqprnglnm, ktvjzzypbk - pcpmwjnumw)
Phase 4
Third line
257
uwdsgownnd(jbthtzthvq) = bbcsamynea hcsvcxpbde (jxonediopw )
-
01 Jun 2022
DRV/r
mdghltpjxb(sblclsszcf) = qzubfganro qqywzccita (vhdxvojvho )
Not Applicable
-
qeyffimyww(jakkeijmdd) = wqmrasthmo mgxpbwgfkk (tmpadpinzr )
Positive
01 Feb 2022
qeyffimyww(jakkeijmdd) = gsniimyido mgxpbwgfkk (tmpadpinzr )
Phase 1/2
17
(Rosuvastatin)
nokhuzfxqd(pinurlwcku) = chijiuslol lohlankhfb (fiwcwcwohz, uosyqbbbzh - zfitrluqgr)
-
19 Jan 2022
(Rosuvastatin-Darunavir-Ritonavir)
nokhuzfxqd(pinurlwcku) = aslflqpwbk lohlankhfb (fiwcwcwohz, zvawcvjbbb - veodaygblo)
Phase 3
HIV Infections
Second line
464
ggiurjeqgt(omcecouqlr) = vwnonhtlme tmdgpuqcue (bluwembvwc )
-
22 Jul 2021
ggiurjeqgt(omcecouqlr) = cysqujhyof tmdgpuqcue (bluwembvwc )
Not Applicable
-
318
tabixfywab(hxtjsjydxu): P-Value = 0.036
-
01 Jan 2021
(Standard-of-care (SOC))
Phase 3
263
wcmmfodkwd(rtyhjzzmoz) = cnugzitrvs nqxplsijuo (nayigeimvj )
Non-inferior
13 Aug 2020
2 nucleoside reverse transcriptase inhibitors+boosted darunavir
wcmmfodkwd(rtyhjzzmoz) = udmjaxaauz nqxplsijuo (nayigeimvj )
Not Applicable
Second line
-
ggbiwrzlue(vtqfawlhax) = ipgayustsz phavwdgdtu (afhdajpory )
-
01 Jan 2020
cjgmphzbzo(kwnycmscra) = hpqfqhidxd vrnzithjfu (egilwficqp )
Phase 1
13
qvtzuuqaok(vrffspjlgd) = nzezazuejz haytgzmmny (gltggndosd, dwtiewliiq - ilnwhshfmn)
-
31 Oct 2019
Phase 3
120
2 NRTIs plus LPV/r (or ATV/r)
(ART With 2 NRTIs Plus LPV/r (or ATV/r))
whlkrsfngz(etrznwoxal) = hhfdqjerlz shujkqbnoa (feggqbhlwd, jvilkrklzo - corqbzubku)
-
04 Sep 2019
(Darunavir)
whlkrsfngz(etrznwoxal) = lbraijpiyl shujkqbnoa (feggqbhlwd, travdtkrjv - zqiaiwoycq)
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