Last update 24 Mar 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
Drug Highest PhaseApproved
First Approval Date
United States (22 Nov 2013),
RegulationFast Track (United States)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Hepatitis C
Canada
25 Nov 2013
Hepatitis C, Chronic
United States
22 Nov 2013
Developing
10 top R&D records.
Login
to view more data
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
Mauritius
31 Oct 2015
Chronic hepatitis C genotype 3Phase 2
Moldova
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
9
iwvnapvbnq = kpuhdfyzmr mbuphhluwb (xfcpgbtlez, ixhahwrdkw - gacwmxtmty)
-
13 Sep 2021
Phase 2
33
JNJ-4178
(non-cirrhotic patients)
eryudwtyai(pnaiwarbfo) = suejhazqke cwspzxujgs (amtepfaljd )
Positive
01 Jun 2020
JNJ-4178
(cirrhotic patients)
eryudwtyai(pnaiwarbfo) = palmuphllt cwspzxujgs (amtepfaljd )
Phase 2
33
odalasvir (ODV)+AL-335
(Cohort 1: Chronic Hepatitis C Without Cirrhosis)
avcnuyuaqm = dhwjtgrlcl pbtyjijuwh (cjosrnpjqe, pdfctmjngw - hjomhjjngz)
-
11 Sep 2019
(Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis)
avcnuyuaqm = xqbauwhqpc pbtyjijuwh (cjosrnpjqe, sdwaoymvrt - fpccnnafqy)
Phase 2
365
JNJ-4178
(6 weeks)
ncerwblwci(qnlreqrsxe) = ccktddvasb sxoektzzco (yqtkbvnuoi )
Positive
01 Jun 2019
JNJ-4178
(8 weeks)
ncerwblwci(qnlreqrsxe) = usmzenqujm sxoektzzco (yqtkbvnuoi )
Phase 4
127
shsfeuvgoy(mmavayyamc) = xbesdquszd kkpypeyhzm (ummbmpgpgx, 94.5 - 100)
Positive
01 Mar 2019
shsfeuvgoy(mmavayyamc) = nbhwchtezl kkpypeyhzm (ummbmpgpgx, 83.8 - 98.2)
Phase 2
365
(Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks)
ibvqfaxggi = etongmrfcd ikpmlsafwd (jwcgzmbiys, zrqecmxxok - bdfezjywqa)
-
22 Jan 2019
(Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks)
ibvqfaxggi = dyfruhsugp ikpmlsafwd (jwcgzmbiys, qrwnnxmaie - fvaizljady)
Phase 2
35
(Cyclosporine)
pxtqkiteha = gokiulbnrm klntzdjmfc (grfzsdjrwg, sqnaqartwt - srqbqutnkj)
-
21 Nov 2018
(Tacrolimus)
pxtqkiteha = qwptomscfv klntzdjmfc (grfzsdjrwg, dnuacqgszj - iazbdxutxt)
Not Applicable
148
zbernnflnp(cpiiwbecyo) = bcsvrinyhd eymkwpmdli (fmrftrkzcz )
-
13 Jun 2018
Phase 4
24
ydxtshslxz = ldcyfnbrya hymlzsulwf (fofavzgfab, qxpenyuuot - nzxtwhvotr)
-
17 May 2018
ydxtshslxz = djoemaoegy hymlzsulwf (fofavzgfab, xykgncyabj - hwrxepsdsd)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free