Elbasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zepatier | — | 2016-07-22 | europa.eu ↗ |
| Approved | US (FDA) | ZEPATIER | — | 2016-01-28 | fda.gov ↗ |
Trials 55 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04546802 Comparator | Sep 2019 → Jun 2021 | chronic hepatitis C virus infection, hepatocellular carcinoma | Bayside Health | Withdrawn | No outcome recorded |
| Phase 3 | NCT02358044 Comparator | Feb → Nov 2015 | hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elbasvir | “Zepatier (elbasvir and grazoprevir +/- Ribavirin) will be administered in a community setting to HCV infected G1/4 treatment naïve patients on stable opiate substitution...” NCT02895958 ↗55“Open-labelled pilot clinical trial of Zepatier (MK-5172 and MK-8742/Grazoprevir + Elbasvir) in at least 20 HCV-negative subjects receiving a heart transplant from a HCV-positive donor.” NCT03146741 ↗ “Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination,Zepatier Oral Product” NCT03186365 ↗ “The study drug is administered as a single tablet; which is a combination of 100 mg of grazoprevir and 50 mg of elbasvir; as outlined below:” NCT03797066 ↗ “Zepatier Open-label Zepatier (grazoprevir 100 mg and elbasvir 50 mg) will be administered in this study.(14, 15)” NCT03791814 ↗ “The dosages of study drugs are 100 mg of grazoprevir once daily and 50 mg of elbasvir once daily.” NCT03037151 ↗ “fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A)” NCT03111108 ↗ “A single FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.” NCT03143998 ↗ “Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks” NCT02781649 ↗ “Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.” NCT03221582 ↗ “ELBASVIR/GRAZOPREVIR (Zepatier, Merck)” NCT03249194 ↗ “Elbasvir Oral Granules” NCT03379506 ↗ |
| Known as | EBR | “This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis...” NCT02115321 ↗10“This study uses pharmacokinetic modeling to identify pediatric doses of elbasvir/grazoprevir (EBR/GZR) that achieve plasma concentrations similar to those seen in adults...” PMID 36790337 ↗ Feb 2023 “Elbasvir (EBR; HCV NS5A inhibitor) and grazoprevir (GZR; HCV NS3/4A protease inhibitor) are approved as a fixed-dose combination to treat patients chronically infected with HCV...” PMID 28470815 ↗ Jun 2017 “The C-EDGE Head-2-Head Study compared the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) with sofosbuvir plus pegylated interferon/ribavirin (SOF/PR) in patients with...” PMID 27542322 ↗ Aug 2016 “Elbasvir (EBR) in combination with grazoprevir (GZR) has demonstrated efficacy in patients with hepatitis C virus (HCV) infections in trials primarily conducted in the USA and Europe.” PMID 27873094 ↗ Nov 2016 “We aimed to assess the efficacy and tolerability of grazoprevir (GZR)/elbasvir (EBR) treatment in genotype-1b (GT-1b) HCV-infected liver or kidney transplant recipients.” PMID 34902265 ↗ Dec 2021 “All patients received elbasvir (EBR) 50 mg/grazoprevir (GZR) 100 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks.” PMID 27770561 ↗ Dec 2016 “Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks” NCT03585101 ↗ “fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A)” NCT03111108 ↗ “Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.” NCT03221582 ↗ “Elbasvir (EBR)” NCT02105454 ↗ |
| Known as | Elbasvir component of zepatier | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039514 ↗ |
| Known as | MK-8742 | “Subjects with Hepatitis C Virus (HCV) infection, genotype 1 or 4 and with hepatocellular carcinoma (HCC) and a complete response to HCC therapy will be randomised to immediate...” NCT04546802 ↗17“PURPOSE: Elbasvir (MK-8742) and grazoprevir (MK-5172; Merck & Co, Inc, Kenilworth, New Jersey) are hepatitis C virus (HCV)-specific inhibitors of the nonstructural protein 5A...” PMID 29703432 ↗ Apr 2018 “Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and...” NCT02105467 ↗ “Open-labelled pilot clinical trial of Zepatier (MK-5172 and MK-8742/Grazoprevir + Elbasvir) in at least 20 HCV-negative subjects receiving a heart transplant from a HCV-positive donor.” NCT03146741 ↗ “This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3.” NCT02133131 ↗ “Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)” NCT02204475 ↗ “Grazoprevir (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA approved combination DAA therapy.” NCT02600325 ↗ “Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)” NCT02252016 ↗ “Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)” NCT02251990 ↗ “Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)” NCT02203149 ↗ “tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin” NCT02732405 ↗ “The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)” NCT01797536 ↗ “Grazoprevir (MK-5172) and Elbasvir (MK-8742)” NCT01937975 ↗ “Grazoprevir (MK-5172) + Elbasvir (MK-8742)” NCT02105701 ↗ “Elbasvir (MK-8742) + Grazoprevir (MK-5172)” NCT03111108 ↗ “grazoprevir (MK-5172) + elbasvir (MK-8742)” NCT02105688 ↗ “Drug: MK5172 /MK8742” NCT02732405 ↗ “MK-8742 (elbasvir)” NCT03222167 ↗ |
| Action | Inhibit | “PURPOSE: Elbasvir (MK-8742) and grazoprevir (MK-5172; Merck & Co, Inc, Kenilworth, New Jersey) are hepatitis C virus (HCV)-specific inhibitors of the nonstructural protein 5A...” PMID 29703432 ↗ Apr 2018 |
| Modality | Small molecule | — CHEMBL3039514 ↗ |
| Route | Oral | “Elbasvir was administered orally by tablet(s)” NCT01532973 ↗ |