Simeprevir
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Olysio | — | 2018-05-01 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | OLYSIO | — | 2014-11-05 – 2016-05-20 | fda.gov ↗ |
| Approved | EU (EMA) | Olysio | — | 2014-05-14 | europa.eu ↗ |
| Approved | US (FDA) | OLYSIO | — | 2013-11-22 | fda.gov ↗ |
Trials 85 · started per year
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02512562 Comparator | Jul → Aug 2015 | chronic hepatitis C virus infection | Alios Biopharma Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04387539 Comparator | Mar → Oct 2017 | chronic hepatitis C virus infection | Beni-Suef University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04385407 Comparator | Apr 2015 → Jul 2016 | chronic hepatitis C virus infection | Beni-Suef University | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05616598 Comparator | Mar → Nov 2022 | hepatitis C virus infection, male infertility | Benha University | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT03069001 Comparator | Jun 2015 → Mar 2016 | hepatitis C virus infection | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02992457 Comparator | Jan 2015 → Dec 2018 | hepatitis C virus infection | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT02702739 Comparator | Jan → Dec 2015 | cirrhosis of liver | Azienda Ospedaliera San Camillo Forlanini | Completed | No outcome recorded |
| Phase 4 | NCT02214420 Comparator | Oct 2014 → Jun 2016 | hepatitis C virus infection | SC Liver Research Consortium, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03133065 Comparator | Sep 2014 → Dec 2016 | — | Ain Shams University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03549832 Comparator | Jan 2018 → Jan 2019 | hepatitis C virus infection | Assiut University | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2012-11-01 | Vertex Pharmaceuticals Incorporated | Vertex Announces Collaboration with Janssen To Initiate Phase 2 All-Oral Study of VX-135 and Simeprevir (TMC435) for the Treatment of Hepatitis C vrtx.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 104 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | simeprevir | “The proposed study will quantify hepatic improvement and antiviral efficacy of the open-label interferon-free combination of 12 weeks of simeprevir (SMV, Simeprevir),...” NCT02455167 ↗49“Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 ↗ Jul 2016 “A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone...” NCT03155893 ↗ “TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection” NCT01846832 ↗ “7 patients were treated with sofosbuvir 400mg + simeprevir 150 mg + weight based ribavirin for 12 weeks after 6 months post transplant.” NCT03133065 ↗ “Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539 ↗ “Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study.” PMID 25192745 ↗ Sep 2014 “Simeprevir (TMC435) is an oral NS3/4 protease inhibitor in phase III trials for chronic hepatitis C virus (HCV) infection.” PMID 24184810 ↗ Nov 2013 “Once-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naïve” PMID 24005956 ↗ Sep 2013 “150 milligram (mg) simeprevir (SMV) capsule with water under fed conditions.” NCT02385071 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02932293 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02583685 ↗ |
| Known as | F021 | “TMC435 (F021)” NCT01134718 ↗ |
| Known as | G006 | “TMC435 (G006)” NCT01134718 ↗ |
| Known as | G007 | “TMC435 (G007)” NCT01134718 ↗ |
| Known as | jnj-38733214-aaa | “TMC435 (also referred to as jnj-38733214-aaa)” NCT01292239 ↗2“TMC435 (also referred to as jnj-38733214-aaa)” NCT01366638 ↗ “TMC435 (also referred to as jnj-38733214-aaa)” NCT01288209 ↗ |
| Known as | OLYSIO | “OLYSIO (Simeprevir) (150mg QD)” NCT02214420 ↗ |
| Known as | Olysio is a trade name of simeprevir | “Olysio is a trade name of simeprevir” NCT04387539 ↗1“Olysio is a trade name of simeprevir” NCT04385407 ↗ |
| Known as | SIMEPREVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL501849 ↗ |
| Known as | SMV | “The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV)...” NCT03155893 ↗16“To investigate the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or simeprevir (SMV) in a randomized, open-label, noninferiority trial” PMID 29906601 ↗ Jun 2018 “Part 1: Simeprevir (SMV) 75 mg taken orally as a component of FDC tablet in Treatment A, B, D and E and as a single agent capsule in Treatment C.” NCT03059303 ↗ “Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539 ↗ “Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.” NCT02397395 ↗ “SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.” NCT02885454 ↗ “150 milligram (mg) simeprevir (SMV) capsule with water under fed conditions.” NCT02385071 ↗ “combination of sofosbuvir (SOF) and simeprevir (SMV)” PMID 27782373 ↗ Dec 2016 “Simeprevir (SMV) 150 mg tablet orally once daily.” NCT02470858 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02583685 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02932293 ↗ “Simeprevir (SMV)” NCT02993250 ↗ “Simeprevir (SMV)” NCT02824315 ↗ “simeprevir (SMV)” PMID 30598598 ↗ Nov 2018 “Simeprevir (SMV)” NCT02421211 ↗ “simeprevir (SMV)” NCT02765490 ↗ “Simeprevir (SMV)” NCT02569710 ↗ |
| Known as | TMC-435 SODIUM SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL501849 ↗ |
| Known as | TMC435 | “During the second OC cycle, participants will receive again Ovysmen once daily during the first 21 days plus TMC435 150 mg once daily as of Day12 till and including Day21.” NCT01486004 ↗45“TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.” NCT01479868 ↗ “Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV)” NCT01938625 ↗ “TMC435 is being investigated for the treatment of chronic hepatitic C infection.” NCT01224197 ↗ “Simeprevir (TMC435)” NCT01707342 ↗ |
| Known as | TMC435350 | “TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection” NCT01846832 ↗6“different dose regimens of TMC435350 (hereafter referred to as TMC435) given alone or in combination with peginterferon alpha-2a (PegIFNa-2a) and ribavirin” NCT00561353 ↗ |
| Action | Inhibit | “blocking an enzyme (protease) that the HCV needs to replicate” NCT00561353 ↗ |
| Modality | Small molecule | “the macrocyclic HCV NS3/4A protease inhibitor TMC435” PMID 19852962 ↗ Oct 2009 |
| Route | Oral | “TMC435 25 mg, 75 mg, 150 mg, or 200 mg capsules taken orally (by mouth) once daily for 21 or 28 days.” NCT00561353 ↗ |