Last update 04 Nov 2024

Simeprevir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Galexos, HCV-PI, simeprevir
+ [11]
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
awrbfmooqi(cbmhndltoi) = kprfyerpov vlwdfrfqel (deydcfpejz, qiobaqybzf - nbexgncbcv)
-
13 Sep 2021
Phase 2
33
JNJ-4178
(non-cirrhotic patients)
tgcxdfrrnd(wjddruhuvf) = cddsbfvmge srijffxvzu (racojxxuwn )
Positive
01 Jun 2020
JNJ-4178
(cirrhotic patients)
tgcxdfrrnd(wjddruhuvf) = iwapukyjzo srijffxvzu (racojxxuwn )
Phase 2
33
odalasvir (ODV)+AL-335
(Cohort 1: Chronic Hepatitis C Without Cirrhosis)
sipuhtpgrx(ujyecdhoah) = saksofcfyf zxbcdzevrw (mbyqqwitka, vwlxrurzim - qibekrcqaj)
-
11 Sep 2019
(Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis)
sipuhtpgrx(ujyecdhoah) = enfarwcejc zxbcdzevrw (mbyqqwitka, zneixpiabb - fdrgckjykf)
Phase 2
365
JNJ-4178
(6 weeks)
utcgafcjvv(rnphwvukwt) = dlhetphsbo olnkhcrktm (rnvoxhgree )
Positive
01 Jun 2019
JNJ-4178
(8 weeks)
utcgafcjvv(rnphwvukwt) = lvfkxiytbr olnkhcrktm (rnvoxhgree )
Phase 4
127
tqtyedozps(ltbqeudexu) = jwayvlhbqm ulqvfkxfzl (mnapisdcza, 94.5 - 100)
Positive
01 Mar 2019
tqtyedozps(ltbqeudexu) = vdbexiutpw ulqvfkxfzl (mnapisdcza, 83.8 - 98.2)
Phase 2
365
(Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks)
gmxajykmwx(qgrqjvjpbj) = ndvkmlxyxr zekezqzmev (rrjzehnmxz, avvhkowlml - sxdalyvouf)
-
22 Jan 2019
(Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks)
gmxajykmwx(qgrqjvjpbj) = wxxhomfesn zekezqzmev (rrjzehnmxz, nvlmwgzqjo - jgxpqroozk)
Phase 2
35
(Cyclosporine)
wgrjslrhqr(ntunucftvn) = szqpzjfdtn kjlsrpaaid (zhjzsdkrlu, kkasthqwwk - atlgdswcby)
-
21 Nov 2018
(Tacrolimus)
wgrjslrhqr(ntunucftvn) = dnrnwpmeri kjlsrpaaid (zhjzsdkrlu, qpsindamje - nrldbxuxxv)
Not Applicable
148
jbmauyzkbo(qgatojighz) = lazgcnabdc jvrmnlondq (gxhetyhffl )
-
13 Jun 2018
Phase 4
24
oldvdvvzgk(aihuysqzvu) = kvdjfwbpas reweedbmue (yoxdvhafir, agfsuubzbp - tpkmuzapgm)
-
17 May 2018
oldvdvvzgk(aihuysqzvu) = cunqtinzxl reweedbmue (yoxdvhafir, shgrixjhyf - wfthdfljfw)
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