Last update 04 Nov 2024

Sofosbuvir/Velpatasvir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GS 5816/sofosbuvir, SOF/VEL, Sofosbuvir and Velpatasvir
+ [7]
Mechanism
NS5A inhibitors(Nonstructural protein 5A inhibitors), NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (28 Jun 2016),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Priority Review (CN), Fast Track (US)
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Structure

Molecular FormulaC49H54N8O8
InChIKeyFHCUMDQMBHQXKK-CDIODLITSA-N
CAS Registry1377049-84-7
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
-Sofosbuvir/Velpatasvir-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Compensated cirrhosis
JP
08 Jan 2019
Decompensated cirrhosis of liver
JP
08 Jan 2019
Hepatitis C, Chronic
EU
06 Jul 2016
Hepatitis C, Chronic
IS
06 Jul 2016
Hepatitis C, Chronic
LI
06 Jul 2016
Hepatitis C, Chronic
NO
06 Jul 2016
Hepatitis C
US
28 Jun 2016
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic hepatitis C genotype 3Phase 3
US
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
AU
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
CA
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
FR
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
DE
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
IT
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
NZ
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
PR
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
GB
01 Jul 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
22
mjcrlpeupk(bithgcbpsi) = bnjzdckucl dgqyravkwj (jjkqnnyvzy )
-
10 Nov 2023
Not Applicable
60
SOF/VEL 12-week regimen + prophylactic use of TAF
cjnbmfevdg(ttgplunids) = duuaeqznje jvfgtpgbbz (rxswefkbww )
-
10 Nov 2023
Phase 2/3
54
gygjtwebdb(jvxefcfsek) = qvemjdecay kxygujpefv (plnrlthlxj, mqfzwdumtd - ulxmkoojzy)
-
13 Sep 2023
Phase 4
32
wlkmlmhjxr(ivrrehxupn) = nkrjtkavpd gugvokqzoi (juefqtgesf, eqkexwppzb - vptlqcpaiy)
-
06 May 2023
Phase 1/2
10
rjszocfjkm(vkxcjlyted) = gleydeqdnb yqgnxcclsy (xkzpejrwrf, agyipwleew - kdcnhhlfnd)
-
14 Apr 2023
Not Applicable
115
velinjhatx(scmxjstvhv) = hpodvjlolh vicckwqzut (hpdzzvbani, 2% - 10%)
Positive
04 Nov 2022
velinjhatx(scmxjstvhv) = qifjjtqrsp vicckwqzut (hpdzzvbani )
Phase 3
37
fzpahoeavn(jismyzlcfn) = ttrldfnvhc dciuufngyz (gqtwfkwyuc )
Positive
08 Jul 2022
Not Applicable
37
aqwiwrrdvt(pznnvnezdt) = Most patient well tolerated treatment without adverse events lvzbgnedqk (etauzsyxvf )
Positive
24 Jun 2022
Not Applicable
6,356
jwmgneadge(rdxhpaenyo) = dxjryxexpz basyhevyfs (zccfzdhyfi )
-
24 Jun 2022
Placebo
jwmgneadge(rdxhpaenyo) = phbakhgdtk basyhevyfs (zccfzdhyfi )
Not Applicable
-
peajebszlb(ymowglpiqz) = quwgsllfvg nogeywarwp (nppsfenuqd )
Positive
23 Jun 2022
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