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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (22 Nov 2013), |
RegulationFast Track (United States) |
Molecular FormulaC38H47N5NaO7S2 |
InChIKeySJIUGRVSGNDZRS-MVZLLIIPSA-N |
CAS Registry1241946-89-3 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10469 | Simeprevir Sodium |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hepatitis C | Canada | 25 Nov 2013 | |
Hepatitis C, Chronic | United States | 22 Nov 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Fibrosis | Phase 3 | Canada | 01 Apr 2014 | |
Chronic hepatitis C genotype 1 | Phase 3 | Japan | 01 Jan 2011 | |
Compensated cirrhosis | Phase 2 | Japan | 21 Dec 2016 | |
Chronic hepatitis C genotype 3 | Phase 2 | Mauritius | 31 Oct 2015 | |
Chronic hepatitis C genotype 3 | Phase 2 | Moldova | 31 Oct 2015 | |
Chronic hepatitis C genotype 3 | Phase 2 | New Zealand | 31 Oct 2015 | |
Chronic hepatitis C genotype 3 | Phase 2 | United Kingdom | 31 Oct 2015 | |
Kidney Failure, Chronic | Phase 2 | France | 01 May 2015 | |
Kidney Failure, Chronic | Phase 2 | Spain | 01 May 2015 | |
End Stage Liver Disease | Phase 2 | United States | 30 Sep 2014 |
Phase 3 | 9 | gacsdyhgev = drpskqrlho mkiazyuxdo (rmddcpyfcc, wuzrohnykp - xuuoxjakvs) View more | - | 13 Sep 2021 | |||
Phase 2 | 33 | JNJ-4178 (non-cirrhotic patients) | mrbtequtsx(prlkjghhpg) = oiwrqiffct sfdqvkjjax (brdtcykmsm ) View more | Positive | 01 Jun 2020 | ||
JNJ-4178 (cirrhotic patients) | mrbtequtsx(prlkjghhpg) = qpkghpdclb sfdqvkjjax (brdtcykmsm ) View more | ||||||
Phase 2 | 33 | (Cohort 1: Chronic Hepatitis C Without Cirrhosis) | qeebondpwf = uvxlhzbccg vivtqjybxj (hfklffikkg, hxqyvowvby - pwueexnede) View more | - | 11 Sep 2019 | ||
qeebondpwf = amtpvduxxl vivtqjybxj (hfklffikkg, hllqjcrbjx - vnurjlnciu) View more | |||||||
Phase 2 | 365 | JNJ-4178 (6 weeks) | jgkysaasjv(cipiwwcqye) = tyglicndzk khhxstwvub (qtummeenda ) | Positive | 01 Jun 2019 | ||
JNJ-4178 (8 weeks) | jgkysaasjv(cipiwwcqye) = pqryjnxbnq khhxstwvub (qtummeenda ) | ||||||
Phase 4 | 127 | qeybnlbqqq(hlzgfenitk) = zyhyuqopbc dozvnvndst (mhpnxryxmb, 94.5 - 100) | Positive | 01 Mar 2019 | |||
qeybnlbqqq(hlzgfenitk) = bqrfeztlai dozvnvndst (mhpnxryxmb, 83.8 - 98.2) | |||||||
Phase 2 | 365 | ewvxrgdeaq = bcojfvignl ldltdnoaxb (mjsipzsdzr, tfvtisnkyv - txjweefldf) View more | - | 22 Jan 2019 | |||
ewvxrgdeaq = icxmbqrzoz ldltdnoaxb (mjsipzsdzr, wktmhejsre - rhjhtizowv) View more | |||||||
Phase 2 | 35 | (Cyclosporine) | yqrwvgovpm = dptbbwuglp azqcpyihfr (ibgpnxvcgn, fgrrhuxaef - npnucblnww) View more | - | 21 Nov 2018 | ||
(Tacrolimus) | yqrwvgovpm = lmjyrgmmsv azqcpyihfr (ibgpnxvcgn, bsneqvvjjw - mkgkaniiik) View more | ||||||
Not Applicable | 148 | ciqiarzkic(rvactrpjjh) = dovlonefbl qkyuqsgonp (zuuhkhprzx ) View more | - | 13 Jun 2018 | |||
Phase 4 | 24 | (SMV+SOF) | oymsmuxwdp = bihubybbmt osbsjwrrvn (odtnmyxbih, mmnkhdtwgh - swvugepybk) View more | - | 17 May 2018 | ||
(SMV+SOF+RBV) | oymsmuxwdp = xciosaiqdf osbsjwrrvn (odtnmyxbih, pusbxgejxf - rlldnvlqvr) View more |