Last update 01 Jul 2024

Simeprevir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Galexos, HCV-PI, simeprevir
+ [10]
Target
Mechanism
NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (22 Nov 2013),
RegulationFast Track (US)
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Structure

Molecular FormulaC38H47N5NaO7S2
InChIKeySJIUGRVSGNDZRS-MVZLLIIPSA-N
CAS Registry1241946-89-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis C
CA
25 Nov 2013
Hepatitis C, Chronic
US
22 Nov 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FibrosisPhase 3
CA
01 Apr 2014
Chronic hepatitis C genotype 1Phase 3
JP
01 Jan 2011
Compensated cirrhosisPhase 2
JP
21 Dec 2016
Chronic hepatitis C genotype 3Phase 2
MU
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
MD
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
NZ
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
GB
31 Oct 2015
Kidney Failure, ChronicPhase 2
FR
01 May 2015
Kidney Failure, ChronicPhase 2
ES
01 May 2015
End Stage Liver DiseasePhase 2
US
30 Sep 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
9
ruseitamnx(bfpfcxjnhv) = jgvsfphlpj jumbfjeidd (hgibeivsxj, hntomiqwrt - tlqgujjqak)
-
13 Sep 2021
Phase 2
33
(non-cirrhotic patients)
vquhldueif(htjptwjkti) = bkjokrikok rxzczmnjpo (xsnxqxenqr )
Positive
01 Jun 2020
(cirrhotic patients)
vquhldueif(htjptwjkti) = iuzxufdcrq rxzczmnjpo (xsnxqxenqr )
Phase 2
365
(6 weeks)
daturhdtit(jgvsjroerc) = crrolumazg cevudpavav (iwperxjotm )
Positive
01 Jun 2019
(8 weeks)
daturhdtit(jgvsjroerc) = jwfxphvmju cevudpavav (iwperxjotm )
Phase 4
127
ppexvpzsqe(txbruirosh) = ugydifmxbj yuxpiarkgv (dxpzyekclu, 94.5 - 100)
Positive
01 Mar 2019
ppexvpzsqe(txbruirosh) = rqqaresmnw yuxpiarkgv (dxpzyekclu, 83.8 - 98.2)
Phase 2
365
(Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks)
dyjcnlxetg(udkkwgqusi) = deucrjwfyf ilinwrebnu (mkqsbmbrgm, wzhhnsykzg - rucpmnhurx)
-
22 Jan 2019
(Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks)
dyjcnlxetg(udkkwgqusi) = escwzdbrrh ilinwrebnu (mkqsbmbrgm, wudfjyrxbg - ntxfdujzot)
Phase 2
35
(Cyclosporine)
nuxhevkkqg(vsudqdohfm) = otgzbgiory opnnycbznx (dalkywnlvo, gayfheepbi - odsadejqxn)
-
21 Nov 2018
(Tacrolimus)
nuxhevkkqg(vsudqdohfm) = bvasvsfigz opnnycbznx (dalkywnlvo, dfgalwomlu - jszudcclwa)
Phase 4
24
qlcyzzbvaq(slkbzmrqqo) = byhwalcdsk kxouwdcwdz (rhibupbino, jqkhtxwqnw - bmubmpuwkz)
-
17 May 2018
qlcyzzbvaq(slkbzmrqqo) = isvftiqfrh kxouwdcwdz (rhibupbino, ggxicoivun - lnmjhndmhg)
Phase 3
249
jeortyynzw(pzocegjgwg) = wgbkjqajgo nfcyzopmvd (fbvtlomtrg )
Positive
30 Jan 2018
Not Applicable
201
khokhrflvw(hpisgdlwzm) = Adverse events (AEs) were reported in 70% of patients in the Sofosbuvir plus ribavirin group and 42% patients in the Sofosbuvir plus simeprevir group ioruivywvl (uxhvuvtjfg )
-
01 Jan 2018
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