Drugs / glecaprevir/pibrentasvir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2016-12-19 | “it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” abbvie.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03781726 | Apr 2019 → Mar 2020 | chronic renal failure syndrome, hepatitis C virus infection | Raymond Chung | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | AbbVie | Regulatory AbbVie Reports Second-Quarter 2026 Financial Results abbvie.com ↗
AbbVie announced the EC approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. |
| 2020-05-01 | AbbVie | Regulatory AbbVie Reports First-Quarter 2020 Financial Results abbvie.com ↗
AbbVie announced that the EC has approved a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. |
| 2020-02-07 | AbbVie | Regulatory AbbVie Reports Full-Year and Fourth-Quarter 2019 Financial Results abbvie.com ↗
AbbVie announced that the CHMP of the EMA has recommended a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. |
| 2019-11-01 | AbbVie | Regulatory AbbVie Reports Third-Quarter 2019 Financial Results abbvie.com ↗
AbbVie announced the FDA approval of MAVYRET (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes. |
| 2017-01-09 | AbbVie | Results Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) for Chronic Hepatitis C Achieved High SVR[12] Rates in Genotype 1 Japanese Patients abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR 12 rates with 8 weeks of treatment with its investigational, pan-genotypic, ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis. |
All press releases naming this drug 27 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | glecaprevir/pibrentasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03781726 ↗ |