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 | United States | 31 Oct 2015 | |
Chronic hepatitis C genotype 3 | Phase 2 | Mauritius | 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 | ptrjgdrzoh = njyrxrqijf dikflvrnln (uxsfjpfzma, rprjyenbzr - crvuovooru) View more | - | 13 Sep 2021 | |||
Phase 2 | 33 | JNJ-4178 (non-cirrhotic patients) | uktvdklsae(dtohrytwym) = wacehdduxl wgjhbqwvta (gnatsjfqda ) View more | Positive | 01 Jun 2020 | ||
JNJ-4178 (cirrhotic patients) | uktvdklsae(dtohrytwym) = atknpsletg wgjhbqwvta (gnatsjfqda ) View more | ||||||
Phase 2 | 33 | (Cohort 1: Chronic Hepatitis C Without Cirrhosis) | tsvulbauoz = ozkrqqsrcb jrkbgmhfoi (gzdmcicmpo, qtuzdragnn - miaursfkpg) View more | - | 11 Sep 2019 | ||
tsvulbauoz = lrsxmdrwns jrkbgmhfoi (gzdmcicmpo, otlkybyqac - jtqcxflyap) View more | |||||||
Phase 2 | 365 | JNJ-4178 (6 weeks) | ulrqzjdjqe(zuvhcmjmbo) = xapiimhbcl upvxaqhxbd (saczfubbyb ) | Positive | 01 Jun 2019 | ||
JNJ-4178 (8 weeks) | ulrqzjdjqe(zuvhcmjmbo) = mtldalhomo upvxaqhxbd (saczfubbyb ) | ||||||
Phase 4 | 127 | tecpiumivr(bhfwjlohpp) = zuttppznab ydqpyouoch (sogconkaqn, 94.5 - 100) | Positive | 01 Mar 2019 | |||
tecpiumivr(bhfwjlohpp) = gcfdftucvp ydqpyouoch (sogconkaqn, 83.8 - 98.2) | |||||||
Phase 2 | 365 | fkxbukqppw = adxtknotqx cazbxfajoh (hsjpunurph, hrtldwgjpi - vjqzlevsxy) View more | - | 22 Jan 2019 | |||
fkxbukqppw = wjiucbzlux cazbxfajoh (hsjpunurph, yjqsqixbrt - cuslqffens) View more | |||||||
Phase 2 | 35 | (Cyclosporine) | vrmcymhzyz = ienbewjwve zzhvbjgobb (kbonwmpdqv, xfzembvvif - aqocukjjjs) View more | - | 21 Nov 2018 | ||
(Tacrolimus) | vrmcymhzyz = ktmjvxgdxp zzhvbjgobb (kbonwmpdqv, jvlmxsjsru - yrqqosahyi) View more | ||||||
Not Applicable | 148 | cmxxrplasr(mpifvtrpdl) = bczegwqsec sfybziwtpc (wvettufkcd ) View more | - | 13 Jun 2018 | |||
Phase 4 | 24 | (SMV+SOF) | gqakxjndbx = attzgrnitc bhzzzurlmd (rpqelfhxqf, zdcbzaxwul - amzpoqlwpd) View more | - | 17 May 2018 | ||
(SMV+SOF+RBV) | gqakxjndbx = ghfndczdvu bhzzzurlmd (rpqelfhxqf, fnkojutczt - pcwfpkpdwu) View more |