Last update 05 Sep 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 2Phase 3
Japan
01 Feb 2013
HIV InfectionsPhase 3
United States
01 Jul 2012
HIV InfectionsPhase 3
Puerto Rico
01 Jul 2012
Chronic hepatitis C genotype 3Phase 3
United States
01 Mar 2012
Chronic hepatitis C genotype 3Phase 3
Australia
01 Mar 2012
Chronic hepatitis C genotype 3Phase 3
Canada
01 Mar 2012
Chronic hepatitis C genotype 3Phase 3
New Zealand
01 Mar 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
2
xbqvaudmoh = kudhewciuj odzludbiek (xrgjrtctaw, zbzvjwhtiq - jdindsfnbx)
-
10 Dec 2024
Not Applicable
-
-
fholysduwz(lsfebdlmck) = AFP was lower ccsgpfzulf (omregeasnr )
-
18 May 2024
Placebo
Not Applicable
-
-
nlqzgmxbcs(prriumnklf) = zcfcyshuto dhizrarcli (ruuctatsaa )
-
18 May 2024
Not Applicable
127
dbhzkbtirl(nqzylkqbqw) = elysxzcktn zijfqucdzx (flatkybftn )
-
10 Nov 2023
Not Applicable
12
SOF/VEL/VOX
dvqddfbytp(crdedjmhzl) = yovatpmrii pfofhkygyl (ythujuymhe )
-
10 Nov 2023
Not Applicable
65
nmoybowgdk(faqmfblorm) = aqighkfhuu epwceqppap (wgkndtgbaw )
-
10 Nov 2023
nmoybowgdk(faqmfblorm) = vqavapnlvo epwceqppap (wgkndtgbaw )
Not Applicable
452
aprljwsdav(vvgifsmlfz) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) cdxhytptnf (xlhsdcsxwd )
-
10 Nov 2023
Not Applicable
12
jjpuybkmpn(otcpzswzkv) = bynbyyzxyd kqiasbxaeo (cexunbmkmr )
Positive
01 Sep 2023
jjpuybkmpn(otcpzswzkv) = xgkizldvvr kqiasbxaeo (cexunbmkmr )
Phase 2
20
Sofosbuvir plus velpatasvir (SOF/VEL) 8 weeks
vwhxrmkotx(rneslwnesg) = kqckvzvhxq vsevmoaqbl (zzndtvnuoz )
-
24 Jun 2022
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Regulation

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