Last update 05 Jun 2025

Simeprevir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Galexos, simeprevir, Simeprevir sodium (JAN)
+ [11]
Target
Action
inhibitors
Mechanism
NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors)
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Nov 2013),
RegulationFast Track (United States)
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Structure/Sequence

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
Canada
25 Nov 2013
Hepatitis C, Chronic
United States
22 Nov 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FibrosisPhase 3
Canada
01 Apr 2014
Chronic hepatitis C genotype 1Phase 3
Japan
01 Jan 2011
Compensated cirrhosisPhase 2
Japan
21 Dec 2016
Chronic hepatitis C genotype 3Phase 2
United States
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
Mauritius
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
New Zealand
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
United Kingdom
31 Oct 2015
Kidney Failure, ChronicPhase 2
France
01 May 2015
Kidney Failure, ChronicPhase 2
Spain
01 May 2015
End Stage Liver DiseasePhase 2
United States
30 Sep 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
9
ptrjgdrzoh = njyrxrqijf dikflvrnln (uxsfjpfzma, rprjyenbzr - crvuovooru)
-
13 Sep 2021
Phase 2
33
JNJ-4178
(non-cirrhotic patients)
uktvdklsae(dtohrytwym) = wacehdduxl wgjhbqwvta (gnatsjfqda )
Positive
01 Jun 2020
JNJ-4178
(cirrhotic patients)
uktvdklsae(dtohrytwym) = atknpsletg wgjhbqwvta (gnatsjfqda )
Phase 2
33
(Cohort 1: Chronic Hepatitis C Without Cirrhosis)
tsvulbauoz = ozkrqqsrcb jrkbgmhfoi (gzdmcicmpo, qtuzdragnn - miaursfkpg)
-
11 Sep 2019
(Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis)
tsvulbauoz = lrsxmdrwns jrkbgmhfoi (gzdmcicmpo, otlkybyqac - jtqcxflyap)
Phase 2
365
JNJ-4178
(6 weeks)
ulrqzjdjqe(zuvhcmjmbo) = xapiimhbcl upvxaqhxbd (saczfubbyb )
Positive
01 Jun 2019
JNJ-4178
(8 weeks)
ulrqzjdjqe(zuvhcmjmbo) = mtldalhomo upvxaqhxbd (saczfubbyb )
Phase 4
127
tecpiumivr(bhfwjlohpp) = zuttppznab ydqpyouoch (sogconkaqn, 94.5 - 100)
Positive
01 Mar 2019
tecpiumivr(bhfwjlohpp) = gcfdftucvp ydqpyouoch (sogconkaqn, 83.8 - 98.2)
Phase 2
365
(Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks)
fkxbukqppw = adxtknotqx cazbxfajoh (hsjpunurph, hrtldwgjpi - vjqzlevsxy)
-
22 Jan 2019
(Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks)
fkxbukqppw = wjiucbzlux cazbxfajoh (hsjpunurph, yjqsqixbrt - cuslqffens)
Phase 2
35
(Cyclosporine)
vrmcymhzyz = ienbewjwve zzhvbjgobb (kbonwmpdqv, xfzembvvif - aqocukjjjs)
-
21 Nov 2018
(Tacrolimus)
vrmcymhzyz = ktmjvxgdxp zzhvbjgobb (kbonwmpdqv, jvlmxsjsru - yrqqosahyi)
Not Applicable
148
cmxxrplasr(mpifvtrpdl) = bczegwqsec sfybziwtpc (wvettufkcd )
-
13 Jun 2018
Phase 4
24
gqakxjndbx = attzgrnitc bhzzzurlmd (rpqelfhxqf, zdcbzaxwul - amzpoqlwpd)
-
17 May 2018
gqakxjndbx = ghfndczdvu bhzzzurlmd (rpqelfhxqf, fnkojutczt - pcwfpkpdwu)
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Regulation

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