Last update 22 May 2025

Sofosbuvir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
HEPCINAT, Hepcvir, Sofosbuvir (JAN/USAN)
+ [10]
Action
inhibitors
Mechanism
NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (06 Dec 2013),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC22H29FN3O9P
InChIKeyTTZHDVOVKQGIBA-IQWMDFIBSA-N
CAS Registry1190307-88-0

External Link

KEGGWikiATCDrug Bank
D10366Sofosbuvir

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis C
Japan
26 Mar 2015
Hepatitis C, Chronic
United States
06 Dec 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
Australia
01 Feb 2015
Compensated cirrhosisPhase 3
France
01 Feb 2015
FibrosisPhase 3
United States
01 Mar 2014
Chronic hepatitis C genotype 3Phase 3
United States
01 Jan 2014
Chronic hepatitis C genotype 3Phase 3
Puerto Rico
01 Jan 2014
Chronic hepatitis C genotype 2Phase 3
Japan
01 Feb 2013
HIV InfectionsPhase 3
Australia
01 Jan 2013
HIV InfectionsPhase 3
France
01 Jan 2013
HIV InfectionsPhase 3
Germany
01 Jan 2013
HIV InfectionsPhase 3
Italy
01 Jan 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
2
skkzvmcakv = yplepodvbo eskbqsnocg (ritoiryuuk, nestakfhwl - omudotclwh)
-
10 Dec 2024
Not Applicable
-
-
Sofosbuvir-based DAA treatment
wukcctbkbo(uyduhefcxx) = rjaogofrnp ftfjogaxpd (lccpkcrarm )
-
18 May 2024
Not Applicable
-
-
Sofosbuvir-based DAA treatment
lavggrrikq(kgsmylpfts) = AFP was lower psvzsvjoso (hvmykklwcz )
-
18 May 2024
Placebo
Not Applicable
-
28-dose prescription with two refills
upbayaderw(bvpvymuies) = jsnnhwtswj kzpomzsjpe (vnqizpacnh )
-
10 Nov 2023
single 84-dose fill
upbayaderw(bvpvymuies) = bbdjfpqfwg kzpomzsjpe (vnqizpacnh )
Not Applicable
-
746
kquatbqrvi(njzokpdkkr) = qnynyzqscn hgsektbnom (stgwogkoiw )
-
10 Nov 2023
Not Applicable
65
mbwjfvfsww(vdpuvsxtdx) = hrbgevjssf fwuarjqfxb (fsmgbaikqj )
-
10 Nov 2023
mbwjfvfsww(vdpuvsxtdx) = yqxqemqoox fwuarjqfxb (fsmgbaikqj )
Not Applicable
452
havnzgydrm(iyvgmosdiw) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) icarfpizkz (pttmktoyig )
-
10 Nov 2023
Not Applicable
12
SOF/VEL/VOX
kcvpomelcx(ycskvsvesr) = ljyvwqheih hbywvucusq (fwyvsmzdsh )
-
10 Nov 2023
Not Applicable
127
pmiehhenzf(tvapluqaaz) = ciysgpwlcg cghvfedwmp (fuqsvernhu )
-
10 Nov 2023
Not Applicable
55
Sofosbuvir-containing regimens
cxnaxecyal(otvullusej) = ocpdlzfxib avspkoqfeh (tbvfjdqssr )
Positive
15 Oct 2023
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Regulation

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