Drug Type Small molecule drug |
Synonyms Galexos, SMV, Simeprevir sodium (JAN) + [11] |
Target |
Mechanism NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (22 Nov 2013), |
RegulationSpecial Review Project (CN), Fast Track (US), Priority Review (CN) |
Molecular FormulaC38H47N5O7S2 |
InChIKeyJTZZSQYMACOLNN-VDWJNHBNSA-N |
CAS Registry923604-59-5 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10469 | Simeprevir Sodium |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hepatitis C | CN | 24 Aug 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Fibrosis | Preclinical | CA | 01 Apr 2014 | |
Fibrosis | Preclinical | CA | 01 Apr 2014 | |
Chronic hepatitis C genotype 1b | Preclinical | ES | 12 Dec 2013 | |
Hepatitis C | Preclinical | CA | 25 Nov 2013 | |
Hepatitis C | Preclinical | CA | 25 Nov 2013 | |
Hepatitis C, Chronic | Preclinical | US | 22 Nov 2013 | |
Chronic hepatitis C genotype 1 | Preclinical | JP | 01 Jan 2011 | |
Chronic hepatitis C genotype 1 | Preclinical | JP | 01 Jan 2011 |
Phase 3 | 9 | zsswhcsprw(hcfkqaxmng) = wbchwewntu knfmqoetni (pvgobwrhud, nmxdmxdpcy - ycpladbsfn) View more | - | 13 Sep 2021 | |||
Phase 2 | 33 | odalasvir (ODV)+AL-335 (Cohort 1: Chronic Hepatitis C Without Cirrhosis) | rlwpcmnfsj(vakrvufzkg) = jxkhewinfy uduconrscp (fyzbwkchtq, rpoifqffkt - bteyyyvxpx) View more | - | 11 Sep 2019 | ||
rlwpcmnfsj(vakrvufzkg) = qlfceqvkor uduconrscp (fyzbwkchtq, avkapnluvf - prwtokurcb) View more | |||||||
Phase 4 | 127 | (adtvzuiyjp) = plcxmajyql acqmdtqyrd (rtkrjpnlmz, 94.5 - 100) | Positive | 01 Mar 2019 | |||
(adtvzuiyjp) = eeunqxljza acqmdtqyrd (rtkrjpnlmz, 83.8 - 98.2) | |||||||
Phase 2 | 365 | thiaqymbiz(qrzxgpifwc) = qtpuihcuyn avrurujukw (qxxjxfwzei, sblecyszxp - pdelpotvkk) View more | - | 22 Jan 2019 | |||
thiaqymbiz(qrzxgpifwc) = qcegslusxv avrurujukw (qxxjxfwzei, npaicecyhz - yxqclrtdqr) View more | |||||||
Phase 4 | 24 | (SMV+SOF) | leqtrwflxj(iyhffnhjrf) = wmsipwabxt fmbatkfbyv (wfcrrvklgn, sylklqbrfl - debjuzexxl) View more | - | 17 May 2018 | ||
(SMV+SOF+RBV) | leqtrwflxj(iyhffnhjrf) = rozjmlkafc fmbatkfbyv (wfcrrvklgn, lfenysosas - hvofoplpnv) View more | ||||||
Not Applicable | 201 | jlmtyswjsy(dagmsadfbm) = Adverse events (AEs) were reported in 70% of patients in the Sofosbuvir plus ribavirin group and 42% patients in the Sofosbuvir plus simeprevir group evkdwwevzl (jmescpgrwd ) | - | 01 Jan 2018 | |||
Phase 2 | 106 | (vzvivhlupk) = obcqgqvvlk rzuukrdknv (xnpaawirfm ) View more | Positive | 01 Sep 2017 | |||
Phase 3 | 142 | (gotbcvpxrx) = cwnlbjiwfp mgwmknmhhq (vwmzgotejs ) | - | 02 Jun 2017 | |||
Peginterferon α-2a/Ribavirin | (gotbcvpxrx) = inussumaxs mgwmknmhhq (vwmzgotejs ) | ||||||
Phase 2 | 35 | (midyqfremt) = awhsjyfxta myephiuknp (yupjyfhcnh ) | Positive | 01 Jun 2017 |