Drugs / Zepatier
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 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT03724149 | Dec 2018 → Dec 2021 | lung disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 1/2 | NCT02743897 | May 2016 → Mar 2022 | end stage renal failure | University of Pennsylvania | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03093740 | Oct 2018 → Dec 2020 | chronic renal failure syndrome, hepatitis C virus infection | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 9
| 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 ↗ |
| 2017-04-21 | 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. |
| 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 ↗ |
| 2016-08-08 | Merck Sharp & Dohme LLC | Results Results from Merck’s Phase 3 Study Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published in Annals of Internal Medicine merck.com ↗
This study demonstrates that people who inject drugs can be effectively treated with direct-acting antiviral therapy. |
| 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 ↗
Results from C-EDGE IBLD demonstrated high rates of sustained virologic response (SVR) 12 weeks after the completion of treatment (SVR12, considered virologic cure) and a safety profile consistent with that observed in prior studies (abstract #SAT-128). |
| 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 ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER ™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA. |
| 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, |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zepatier | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02743897 ↗ |
| Modality | Other / unclassified | “Direct-acting antiviral treatment for HCV” NCT02743897 ↗ |
| Route | Oral | “is taken by mouth” NCT02743897 ↗ |