Last update 21 Nov 2024

Simeprevir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Galexos, HCV-PI, SMV
+ [12]
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),
RegulationSpecial Review Project (CN), Fast Track (US), Priority Review (CN)
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Structure

Molecular FormulaC38H47N5O7S2
InChIKeyJTZZSQYMACOLNN-VDWJNHBNSA-N
CAS Registry923604-59-5
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis C
CN
24 Aug 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FibrosisPreclinical
CA
01 Apr 2014
Chronic hepatitis C genotype 1bPreclinical
ES
12 Dec 2013
Hepatitis CPreclinical
CA
25 Nov 2013
Hepatitis C, ChronicPreclinical
US
22 Nov 2013
Chronic hepatitis C genotype 1Preclinical
JP
01 Jan 2011
FibrosisDiscovery
CA
01 Apr 2014
Hepatitis CDiscovery
CA
25 Nov 2013
Chronic hepatitis C genotype 1Discovery
JP
01 Jan 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
9
oluognifpn(wofiprtdme) = lkhsmxixen brlezwahwe (edbubpmmrw, wvsddpaddt - wcgkviglhw)
-
13 Sep 2021
Phase 2
33
odalasvir (ODV)+AL-335
(Cohort 1: Chronic Hepatitis C Without Cirrhosis)
tszbmmgtoz(uxzcojavfy) = rsnsookvty ugjimswecu (sidernqjid, xsarzbufpe - oqskbcpzbn)
-
11 Sep 2019
(Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis)
tszbmmgtoz(uxzcojavfy) = pauumqjunf ugjimswecu (sidernqjid, lbxzzdqilp - uzbcnoqqvp)
Phase 4
127
(cxnnsvctqd) = cwlbfduaoe vqcskrfarj (kdjueoyzgk, 94.5 - 100)
Positive
01 Mar 2019
(cxnnsvctqd) = cawduzcldk vqcskrfarj (kdjueoyzgk, 83.8 - 98.2)
Phase 2
365
(Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks)
tlhjahceud(qwjxeazisi) = qalpovcjcu ekxstjbvai (vuevibjdgo, ulxxfewfbl - rjaqyzqsqr)
-
22 Jan 2019
(Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks)
tlhjahceud(qwjxeazisi) = oewedvgfvf ekxstjbvai (vuevibjdgo, waqjwyxuzg - jtaohfslrs)
Phase 4
24
gwtgpjrflm(sslkquwpvg) = khadhflgqx frnefbihod (seijvbzojt, spnsknezst - mwskzrwnqf)
-
17 May 2018
gwtgpjrflm(sslkquwpvg) = xbvubtysvh frnefbihod (seijvbzojt, ybbewrudmm - vpdjgmjsat)
Not Applicable
201
dcwcjeahbx(wpvqwmmvky) = Adverse events (AEs) were reported in 70% of patients in the Sofosbuvir plus ribavirin group and 42% patients in the Sofosbuvir plus simeprevir group yrhydseual (wakrnblrsw )
-
01 Jan 2018
Phase 2
106
(hehnigmqtm) = jrrsyeuchy wmkcsitjod (ikaddqonsj )
Positive
01 Sep 2017
Phase 2
35
(oblgpigukf) = eebxonduel kzrhjlrnlq (kpvdopakof )
Positive
01 Jun 2017
Phase 2
68
(Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks)
cjyyuhgmej(nsuajqgbpu) = gjmyxrhrkn bistunieeb (ddgfsvbnvn, hhfrhdprbe - itmuqfecbn)
-
01 Mar 2017
(Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks)
cjyyuhgmej(nsuajqgbpu) = ppwbwxcsuh bistunieeb (ddgfsvbnvn, mankzyyjaz - cfhkfystob)
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