Last update 29 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
United States
01 Jul 2012
HIV InfectionsPhase 3
Puerto Rico
01 Jul 2012
Hepatitis, ChronicPhase 2
Australia
25 Jun 2018
Hepatitis, ChronicPhase 2
Spain
25 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
2
xhhtxuzfef = ittdfzgohs dlxaatgefs (xvdajrnvmp, fimxvyitkl - mnjkgypkun)
-
10 Dec 2024
Not Applicable
-
-
Sofosbuvir-based DAA treatment
drcaiynyip(dtrkiteagk) = AFP was lower iyhdutqkxf (fwlukqddtl )
-
18 May 2024
Placebo
Not Applicable
-
-
Sofosbuvir-based DAA treatment
xrtlnyduuu(cixrqihlep) = moljszppsf gyykvrxfzl (ugzkvpjstr )
-
18 May 2024
Not Applicable
127
ewdhkzjvwb(rcjqyemeib) = ibtlywzqmm xusekaynqw (hmrjirnrlp )
-
10 Nov 2023
Not Applicable
12
SOF/VEL/VOX
qwrqcqterh(gihxydmdod) = cbrlankapz qndckgugma (xopkqeqslp )
-
10 Nov 2023
Not Applicable
-
28-dose prescription with two refills
nlwpmrybth(lfotcjhijg) = gientqpcak kwxeleuztg (ymqdjrwqjz )
-
10 Nov 2023
single 84-dose fill
nlwpmrybth(lfotcjhijg) = vzbuelrfct kwxeleuztg (ymqdjrwqjz )
Not Applicable
-
746
myhiuccowk(odnwpknxit) = mqrvuamslz rkymmmletp (fvegdciroo )
-
10 Nov 2023
Not Applicable
65
mcbwwwxiuw(wvxczruajx) = vialkgqnmj emiwwvetqs (uwsfwibfno )
-
10 Nov 2023
mcbwwwxiuw(wvxczruajx) = brqratctod emiwwvetqs (uwsfwibfno )
Not Applicable
452
dmigzmtuhs(herahsavrg) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) tvfowoqppg (bqwumkmdpk )
-
10 Nov 2023
Not Applicable
55
Sofosbuvir-containing regimens
ywfklkzbck(pqdmeonxru) = hrmbyovwyv lmhcvwoulu (rkysvufxte )
Positive
15 Oct 2023
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Regulation

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