Elbasvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 1 milestone | |||||
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-07-28 | “Food and Drug Administration (FDA) has accepted for review the New Drug Application for grazoprevir/elbasvir” merck.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Zepatier | — | 2016-07-22 | europa.eu ↗ |
| Approved | US (FDA) | ZEPATIER | — | 2016-01-28 | fda.gov ↗ |
Trials 55
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2017-10-21 | Merck Sharp & Dohme LLC | Results Real-World Study Shows ZEPATIER® (Elbasvir and Grazoprevir) Resulted in High Rates of Sustained Virologic Response in Patients with Chronic Hepatitis C Infection Who Have Chronic Kidney Disease merck.com ↗ |
| 2017-04-22 | Merck Sharp & Dohme LLC | Results Merck Announces New Phase 2 Data on Investigational Triple Combination Therapy MK-3682B for Chronic Hepatitis C merck.com ↗
The study showed that 100 percent (43/43) of patients who completed 16 weeks of treatment plus ribavirin (RBV) achieved SVR12 and 100 percent (49/49) of patients who completed 24 weeks of treatment achieved SVR12 (abstract PS-159). |
| 2017-04-21 | Merck Sharp & Dohme LLC | Results Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s ZEPATIER® (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C merck.com ↗
For the evaluable population (n=2,436), 95.6 percent of veterans treated with ZEPATIER achieved the primary outcome of sustained virologic response (SVR), defined as undetectable HCV RNA at least twelve weeks after the end of treatment. |
| 2017-04-05 | Merck Sharp & Dohme LLC | Results Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017 merck.com ↗
Successful Treatment of Patients With HCV GT3 Infection and Cirrhosis with Elbasvir/Grazoprevir Plus Sofosbuvir Does Not Correct Insulin Resistance by 12 weeks Post-Treatment |
| 2016-11-13 | Merck Sharp & Dohme LLC | Results Merck Announces Findings for Investigational Triple-Combination Chronic Hepatitis C Therapy Showing High Rates of Sustained Virologic Response in People with Genotypes 1, 2 or 3 Infection merck.com ↗
Eight weeks of treatment with MK-3682B resulted in SVR12 rates of 95 percent, 86 percent and 95 percent in GT1, GT2 and GT3 patients, respectively. |
| 2016-11-12 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of New Findings for ZEPATIER™ (Elbasvir and Grazoprevir) in Patients with Chronic Hepatitis C at The Liver Meeting® merck.com ↗
The analysis showed 97 percent of patients (1040/1070) achieved sustained virologic response 12 weeks after the completion of therapy (SVR12, considered virologic cure). |
| 2016-05-27 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union merck.com ↗
The CHMP positive opinion will be reviewed by the European Commission. |
| 2016-04-16 | Merck Sharp & Dohme LLC | Results Merck Announces Results From Phase 3 Studies of ZEPATIER™ (Elbasvir and Grazoprevir) in Chronic Hepatitis C Patient Populations at The International Liver Congress™ merck.com ↗
Findings from C-EDGE CO-STAR showed a high rate of SVR 24 weeks after completion of treatment (SVR24) for the baseline chronic HCV infection and provided insights into the incidence of reinfection in this high risk population (abstract #SAT-163). |
| 2016-04-13 | Merck Sharp & Dohme LLC | Results Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial merck.com ↗
In this study, ZEPATIER demonstrated superiority on efficacy and safety endpoints compared to sofosbuvir plus pegIFN/RBV, based on pre-specified analyses. |
| 2016-01-28 | Merck Sharp & Dohme LLC | Regulatory Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review merck.com ↗ |
| 2015-12-18 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Update on European Medicines Agency Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir merck.com ↗
The CHMP advised Merck that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. |
| 2015-11-16 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Results from Two Phase 2 Studies of Investigational Triple-Combination Chronic Hepatitis C Therapy at The Liver Meeting® merck.com ↗ |
| 2015-11-15 | Merck Sharp & Dohme LLC | Results Merck to Release Findings from Integrated Analysis of Six Phase 2 and 3 Clinical Trials Evaluating Investigational Elbasvir/Grazoprevir in Patients with Chronic Hepatitis C Genotype 1, 4 or 6 Infection and Compensated Cirrhosis at The Liver Meeting® merck.com ↗
Treatment-experienced patients who received elbasvir/grazoprevir with or without RBV for 12 weeks achieved virologic cure rates of 91 percent (74/81) and 89 percent (48/54), respectively. |
| 2015-11-15 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase 3 Results of Investigational Elbasvir/Grazoprevir in People with Chronic Hepatitis C Genotypes 1, 4 or 6 Infection Who Inject Drugs and Are on Opioid Agonist Therapy merck.com ↗
Ninety-five percent (189/198) of patients treated with elbasvir/grazoprevir for 12 weeks in the pre-specified primary efficacy analysis population achieved sustained virologic response 12 weeks after the completion of treatment (SVR12, considered virologic cure). |
| 2015-10-05 | Merck Sharp & Dohme LLC | Results Results from Merck’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet merck.com ↗
The peer-reviewed, published results show that 12 weeks of therapy with elbasvir plus grazoprevir in patients with chronic HCV GT1 infection and advanced CKD resulted in high rates of sustained virologic response 12 weeks after the completion of treatment (SVR12). |
| 2015-07-28 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Second-Quarter 2015 Financial Results merck.com ↗
Grazoprevir/Elbasvir Chronic Hepatitis C Combination Regimen Accepted for Regulatory Review in Both the United States and European Union |
| 2015-07-23 | Merck Sharp & Dohme LLC | Regulatory Merck Announces European Medicines Agency Acceptance of Marketing Authorization Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection merck.com ↗
today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection. |
| 2015-05-28 | Merck Sharp & Dohme LLC | Regulatory Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. |
| 2015-04-25 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver CongressTM 2015 merck.com ↗
Following 12 weeks of treatment with a combination of grazoprevir and elbasvir plus RBV, 96 percent of the patients (76/79) with chronic HCV GT1 infection who had failed prior treatment with specified DAA-based regimens achieved SVR12. |
| 2015-04-23 | Merck Sharp & Dohme LLC | Results Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection merck.com ↗
Patients in both the HCV infected, treatment-naïve ( C-EDGE TN ), and HIV/HCV co-infected, treatment-naïve ( C-EDGE CO-INFXN ) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). |
| 2015-04-23 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease merck.com ↗
Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12). |
| 2015-04-08 | Merck Sharp & Dohme LLC | Regulatory Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015 merck.com ↗ |
| 2014-11-11 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Naïve and Difficult-to-Cure Patients merck.com ↗
The final results were presented in oral sessions at the 65 th American Association for the Study of Liver Diseases (AASLD) Annual Meeting (also known as The Liver Meeting ® ) and published as separate papers online in The Lancet . |
| 2014-11-09 | Merck Sharp & Dohme LLC | Results Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir in Combination with a Nucleotide Inhibitor (C-SWIFT study) Presented at The Liver Meeting® merck.com ↗
“These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients,” said Dr. Lawitz. |
| 2014-04-10 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Chronic Hepatitis C Combination Therapy MK-5172/MK-8742 Demonstrates Antiviral Activity in Hard-to-Cure Patients with HCV Genotype 1 Infection merck.com ↗
Interim analysis of hard-to-cure 1 patients administered MK-5172/MK-8742 with and without ribavirin (RBV) for 12 or 18 weeks showed sustained viral response 2 (SVR), 4 to 8 weeks after the completion of therapy (SVR4/8): |
| 2014-04-09 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Studies Evaluating Investigational Hepatitis C Treatments, MK-5172 and MK-8742, in Treatment-Naïve Patients with Genotype 1 Infection merck.com ↗
a sustained viral response 1 (SVR) was observed in 98 percent (42/43) of patients administered MK-5172/MK-8742 alone and 94 percent (75/80) in those administered MK-5172/MK-8742 plus RBV. |
| 2014-03-05 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Hepatitis C Treatment Regimen MK-5172/MK-8742 Shows Robust Anti-HCV Activity in HIV/HCV Co-Infected Patients with HCV Genotype 1 Infection merck.com ↗
In these co-infected patients, the administration of MK-5172/MK-8742 for 12 weeks resulted in robust HCV suppression, and a safety profile consistent with that observed for patients infected with HCV Genotype 1 infection (GT1) alone. |
| 2013-11-02 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Interim Data from Study of Investigational Combination of HCV Therapies MK-5172 and MK-8742 at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting merck.com ↗
The interim data show that the administration of MK-5172 and MK-8742 in combination is associated with a sustained virologic response (lack of detectable and quantifiable HCV) 12 weeks following the end of study therapy (SVR12). |
| 2013-10-22 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742, an Investigational Oral Combination Regimen for the Treatment of Chronic Hepatitis C Virus (HCV) Infection merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted MK-5172/MK-8742 Breakthrough Therapy designation for treatment of chronic hepatitis C virus infection. |
All press releases naming this drug 38 releases
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 ↗ |
| 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 ↗ |
| 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 ↗ |