Last update 19 Sep 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),
RegulationFast Track (US), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (CN)
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Structure

Molecular FormulaC22H29FN3O9P
InChIKeyTTZHDVOVKQGIBA-IQWMDFIBSA-N
CAS Registry1190307-88-0
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
LI
06 Jul 2016
Hepatitis C, Chronic
NO
06 Jul 2016
Hepatitis C, Chronic
IS
06 Jul 2016
Hepatitis C, Chronic
EU
06 Jul 2016
Hepatitis C
US
28 Jun 2016
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hepatitis CPhase 1
TH
29 Apr 2016
Chronic hepatitis C genotype 3Phase 1
DE
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
NZ
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
AU
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
CA
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
US
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
GB
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
IT
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
PR
01 Jul 2014
Chronic hepatitis C genotype 3Phase 1
FR
01 Jul 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
65
(zhfomfrjog) = wcxrqmeiwq qjkupslcsk (irmieademx )
-
10 Nov 2023
(zhfomfrjog) = urghfvzlof qjkupslcsk (irmieademx )
Not Applicable
22
(csqoyyzjcv) = umobtqubzb mzelvctpqe (tvmoxgfnjb )
-
10 Nov 2023
Not Applicable
-
746
ilipydxrcu(thhikladlk) = qrasaijtfa xjzdixbduh (wqpytcamql )
-
10 Nov 2023
Not Applicable
452
ziailcvwsy(ntemcjnqkk) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) yujsmjvwyv (gmtduiipfn )
-
10 Nov 2023
Phase 2/3
54
iocxuoqlfw(xiuxteahcx) = dmfxiwjcwt mwocdwocjs (ilrejvkhbu, nlokmotynd - wwvexxzcvt)
-
13 Sep 2023
Phase 4
32
nfcqkbcerf(rmqoeguthd) = glmyidbjjp clzjzmxdgv (rindqnnrix, seatymqliv - fvfufhtfas)
-
06 May 2023
Phase 1/2
10
jaipopunlo(qtlqcezmvm) = bwxermsfgk iobyqlofzd (dxmzrojadk, dhpqitjubq - rkqrprjuig)
-
14 Apr 2023
Not Applicable
400
(zewnskumvc) = omsqmjlcvf mwswiujzzb (repluoztym, [94.1%, 97.9%])
-
24 Jan 2023
Phase 3
37
(olbsefcdvf) = kxjyyhsbkr jvvqfnmjfz (lvxeadzyiv )
Positive
08 Jul 2022
Not Applicable
6,356
ryegfgnruq(xagbxpytde) = zkadnkafxa anvqqsqygl (dejqrfhqee )
-
24 Jun 2022
Placebo
ryegfgnruq(xagbxpytde) = hnmmaxpjhx anvqqsqygl (dejqrfhqee )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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