Glecaprevir/Pibrentasvir

Developed for: hepatitis C virus infection
Investigated by: AbbVie

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	“announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” abbvie.com ↗

Trials 1

today NCT02939989 · Ph 3

20172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT02939989	Nov 2016 → May 2021	hepatitis C virus infection	AbbVie	Completed	No outcome recorded

Press releases naming this drug 23 releases

Date	Issuer	Release
2026-06-23	AbbVie	AbbVie Announces European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus Infection abbvie.com ↗
2026-05-22	AbbVie	AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection abbvie.com ↗
2025-06-11	AbbVie	U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus abbvie.com ↗
2020-03-06	AbbVie	European Commission Grants AbbVie Marketing Authorization Shortening MAVIRET® (glecaprevir/pibrentasvir) Treatment Duration to Eight Weeks for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis abbvie.com ↗
2020-01-31	AbbVie	AbbVie Receives Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks in Genotype 3, Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis abbvie.com ↗
2019-09-26	AbbVie	AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes abbvie.com ↗
2019-08-02	AbbVie	AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) Approved by European Commission to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis abbvie.com ↗
2018-11-13	AbbVie	AbbVie's MAVYRET™ (glecaprevir/pibrentasvir) Shows High Virologic Cure* Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗
2018-11-12	AbbVie	AbbVie and the Medicines Patent Pool Complete New Licensing Agreement to Ensure Sustainable Access to Pan-genotypic Hepatitis C Medicine Glecaprevir/Pibrentasvir abbvie.com ↗
2017-10-11	AbbVie	AbbVie Demonstrates Leadership in HCV with New MAVYRET™ (glecaprevir/pibrentasvir) Data to be Presented at The Liver Meeting® 2017 abbvie.com ↗
2017-09-27	AbbVie	AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in Japan abbvie.com ↗
2017-08-03	AbbVie	AbbVie Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks abbvie.com ↗
2017-07-28	AbbVie	European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) abbvie.com ↗
2017-06-23	AbbVie	AbbVie Receives CHMP Positive Opinion for MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) abbvie.com ↗
2017-04-21	AbbVie	Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR(12) Rates in Challenging to Treat Genotype 3 Chronic Hepatitis C abbvie.com ↗
2017-04-20	AbbVie	AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved 99 Percent SVR(12) Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗
2017-03-14	AbbVie	AbbVie Granted Priority Review in Japan for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C abbvie.com ↗
2017-02-02	AbbVie	U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) abbvie.com ↗
2017-01-24	AbbVie	European Medicines Agency Grants Accelerated Assessment, Validates Marketing Authorization Application for AbbVie's Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) abbvie.com ↗
2017-01-09	AbbVie	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 ↗
2016-12-19	AbbVie	AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C abbvie.com ↗
2016-11-15	AbbVie	AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease abbvie.com ↗
2016-11-11	AbbVie	Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C abbvie.com ↗

Evidence & citations 2 cited values

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 NCT02939989 ↗
Route	Oral	“Coformulated tablet for oral administration” NCT02939989 ↗