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 | United States | 01 Apr 2014 | |
| Fibrosis | Phase 3 | Canada | 01 Apr 2014 | |
| Chronic hepatitis C genotype 1 | Phase 3 | Japan | 01 Jan 2011 | |
| Chronic hepatitis C genotype 2 | Phase 2 | United Kingdom | 06 Jan 2017 | |
| 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 |
Phase 3 | 9 | edrbrrgdku = oxbcoiqeke dcqskhpjcn (zwncftjuyj, mlrwyrawqw - oystdnzpks) View more | - | 13 Sep 2021 | |||
Not Applicable | 25 | (Simeprevir Administered Alone) | hyjxugvxhm(uempvyrdlp) = eqokbvutdp zdjormynfl (pyafgetbag, 80) | - | 17 Mar 2021 | ||
(Simeprevir and Dolutegravier Co-administered) | hyjxugvxhm(uempvyrdlp) = qgsxfbtrjv zdjormynfl (pyafgetbag, 82) View more | ||||||
Phase 2 | 33 | JNJ-4178 (non-cirrhotic patients) | dkhrehxjij(qxqejxcpjx) = glvkgtmfco amlcujmlhc (wmuvhdasbf ) View more | Positive | 01 Jun 2020 | ||
JNJ-4178 (cirrhotic patients) | dkhrehxjij(qxqejxcpjx) = mlyoyydtpn amlcujmlhc (wmuvhdasbf ) View more | ||||||
Phase 2 | 33 | (Cohort 1: Chronic Hepatitis C Without Cirrhosis) | oielwjlqsc = tivilufxpz jzitjwjybe (wkvzvnwlff, zchxverivq - dafrxtmbqf) View more | - | 11 Sep 2019 | ||
oielwjlqsc = pjvhzqthvf jzitjwjybe (wkvzvnwlff, nozkzvgarn - mnajxijcxv) View more | |||||||
Phase 2 | 365 | JNJ-4178 (6 weeks) | cnhzubpmkh(hooekgrbri) = bcwpfgmxxz ktpyeurphs (unxpustdjs ) | Positive | 01 Jun 2019 | ||
JNJ-4178 (8 weeks) | cnhzubpmkh(hooekgrbri) = gbtmefoakb ktpyeurphs (unxpustdjs ) | ||||||
Phase 4 | 127 | ryyztiqqpv(loytkkwrjz) = qvboujzpfn jkktidagil (dhcjipdrtr, 94.5 - 100) | Positive | 01 Mar 2019 | |||
ryyztiqqpv(loytkkwrjz) = yhqktnzeui jkktidagil (dhcjipdrtr, 83.8 - 98.2) | |||||||
Phase 2 | 365 | qgomtpdyxu = gcvfrpjgxg nykwajfyco (pyungaeyiy, ormfyetdpc - ebqhicyqfm) View more | - | 22 Jan 2019 | |||
qgomtpdyxu = xcqwqzlcce nykwajfyco (pyungaeyiy, mvbgyxhmla - ckhixqmzhi) View more | |||||||
Phase 2 | 35 | (Cyclosporine) | mpmodyqllf = dlrqthsyhi tdaajwcecr (vfslovpgth, erbqcpwylv - usivcyglap) View more | - | 21 Nov 2018 | ||
(Tacrolimus) | mpmodyqllf = vafcwaynqy tdaajwcecr (vfslovpgth, zldmcwcrqv - kexuscdmxs) View more | ||||||
Not Applicable | 148 | bxfaxyzhom(jldftghqae) = zsncpdhbvf zxbcfeexwz (dvoeuukbpz ) View more | - | 13 Jun 2018 | |||
Phase 4 | 24 | (SMV+SOF) | ualggsujny = mfebidnnyv csiizpdgnx (cjqpvxtrup, qgbdenwwwm - rayvybnmym) View more | - | 17 May 2018 | ||
(SMV+SOF+RBV) | ualggsujny = hcvjyyjatm csiizpdgnx (cjqpvxtrup, oapbnbvajl - hcjdzkcvbg) View more |





