Drugs / Zepatier
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 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| 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 | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02115321 | May 2014 → Mar 2015 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03093740 | Oct 2018 → Dec 2020 | chronic renal failure syndrome, hepatitis C virus infection | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT03093415 | May 2017 → Jun 2019 | hepatitis C virus infection, substance abuse | Oregon Health and Science University | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zepatier | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02743897 ↗ |
| Known as | elbasvir-grazoprevir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03093415 ↗ |
| Known as | MK-5172A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02115321 ↗ |
| Modality | Other / unclassified | “Direct-acting antiviral treatment for HCV” NCT02743897 ↗ |
| Route | Oral | “MK-5172A FDC tablet containing GZR 100 mg + EBR 50 mg taken q.d. by mouth.” NCT02115321 ↗ |