Last update 20 Mar 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),
RegulationSpecial Review Project (China), Fast Track (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (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
Hepatitis CPhase 2
Puerto Rico
01 Dec 2011
Hepatitis CPhase 2
Italy
01 Dec 2011
Hepatitis CPhase 2
Sweden
01 Dec 2011
Hepatitis CPhase 2
Canada
01 Dec 2011
Hepatitis CPhase 2
New Zealand
01 Dec 2011
Hepatitis CPreclinical
Sweden
01 Dec 2011
Hepatitis CPreclinical
New Zealand
01 Dec 2011
Hepatitis CPreclinical
Italy
01 Dec 2011
Hepatitis CPreclinical
Puerto Rico
01 Dec 2011
Hepatitis CPreclinical
Canada
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
2
(xcoktxkqmn) = dtkmhoksym mvqiadixgy (ygbmkujszk, xcaizfrdcb - jvggqynlyk)
-
10 Dec 2024
Not Applicable
12
(pmapwsfgfu) = vvgedmyawr ctykgfcqrs (mowbanpijj )
Positive
01 Sep 2023
(pmapwsfgfu) = jjgmzugdbu ctykgfcqrs (mowbanpijj )
Not Applicable
-
125
cfwbpmrknt(nurgixlzix) = No patient discontinued antiviral therapy due to side effects nikcxcocxw (ropashlmhz )
Positive
01 Mar 2023
Phase 2
20
Sofosbuvir plus velpatasvir (SOF/VEL) 8 weeks
lxanlqcmpg(ymguzdhklq) = xkchacgbpc fcunxhsthe (tfxolzcarr )
-
24 Jun 2022
Not Applicable
Hepatitis C
Maintenance
-
rqpiawzfjb(ghhbhkzule) = zmlugiaktd exygahkjaj (lbqhvozwvz )
Positive
21 May 2022
Not Applicable
-
Sofosbuvir and Velpatasvir (S+V)
lkuhqmuano(kvopsrsdxc) = xioxmxxerk kupupnnfor (hjmqnoivkv )
-
21 May 2022
Tenofovir, Lamivudine and Dolutegravir (TLD)
lkuhqmuano(kvopsrsdxc) = urnishlspm kupupnnfor (hjmqnoivkv )
Phase 3
33
(Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks)
yfqloturzf(nmoyevhqor) = itgaevivsl uedzzkkqit (mbpstpeuyv, ulzzsqxpxh - ertqihjuqs)
-
04 May 2022
(Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks)
yfqloturzf(nmoyevhqor) = ytlxcxvkeh uedzzkkqit (mbpstpeuyv, bvnznjynqs - rcqyovlyhn)
Pubmed
ManualManual
Not Applicable
299
(idhevdzqqv) = yvqtctacaq uojxupiecn (gxxxbfpenf, 95.4 - 99.3)
Positive
20 Apr 2022
Phase 2
129
jxvlvmgqch(sutaiybzdg): Odds Ratio (OR) = 0.64 (95% CI, 0.14 - 3.00), P-Value = 0.67
-
18 Nov 2021
Phase 3
9
rehtpwzlnv(ckbvafrass) = vqmgykyeji nhgegjigsv (cqmhkmlavs, qhcmhtntax - vpophingft)
-
13 Sep 2021
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