Drugs / glecaprevir
glecaprevir
also known as
ABT-493 · Epclusa · Mavyret · ABT-493 also known as glecaprevir · GLE · glecaprevir-pibrentasvir · A-1282576 · A-1282576.0 · +5 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Epclusa | — | 2016-07-06 | europa.eu ↗ |
| Approved | US (FDA) | EPCLUSA | — | 2016-06-28 | fda.gov ↗ |
Trials 55 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02441283 Comparator | Jun 2015 → Oct 2019 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03123965 Background | — | hepatitis C virus infection | AbbVie | Approved for marketing | No outcome recorded |
Press releases naming this drug 35 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 ↗ |
| 2021-06-10 | Gilead Sciences | U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C gilead.com ↗ |
| 2020-03-19 | Gilead Sciences | U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection gilead.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 ↗ |
| 2019-01-08 | Gilead Sciences | Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) gilead.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 ↗ |
| 2018-09-24 | Gilead Sciences | Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗ |
| 2018-05-30 | Gilead Sciences | China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.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 ↗ |
| 2017-08-01 | Gilead Sciences | U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV gilead.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 ↗ |
| 2017-01-20 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) gilead.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 ↗ |
| 2016-07-08 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗ |
| 2016-06-28 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗ |
| 2016-05-27 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗ |
| 2016-04-16 | AbbVie | AbbVie Presents New Phase 2 Data for Investigational, Once-Daily, Ribavirin-Free, Pan-Genotypic Regimen of ABT-493 and ABT-530 for Hepatitis C Genotypes 1-6 abbvie.com ↗ |
| 2016-04-15 | AbbVie | AbbVie's Investigational, Pan-Genotypic Regimen of ABT-493 and ABT-530 Shows High SVR Rates in Genotype 1 Hepatitis C Patients Who Failed Previous Therapy with Direct-Acting Antivirals abbvie.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | glecaprevir | “glecaprevir and pibrentasvir are hepatitis C virus (HCV) pangenotypic inhibitors targeting NS3/4A protease and NS5A, respectively.” PMID 29180522 ↗ Jan 201828“pangenotypic DAA regimen of glecaprevir and pibrentasvir (G/P)” PMID 30977945 ↗ May 2019 “Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6” NCT03702218 ↗ “ABT-493 also known as glecaprevir” NCT02446717 ↗ “ABT-493 also known as glecaprevir” NCT02651194 ↗ “ABT-493 also known as glecaprevir” NCT02642432 ↗ |
| Known as | A-1282576 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545363 ↗ |
| Known as | A-1282576.0 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545363 ↗ |
| Known as | ABT-493 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02296905 ↗ |
| Known as | ABT-493 also known as glecaprevir | “ABT-493 also known as glecaprevir” NCT02636595 ↗5“ABT-493 also known as glecaprevir” NCT02640157 ↗ “ABT-493 also known as glecaprevir” NCT02640482 ↗ “ABT-493 also known as glecaprevir” NCT02738138 ↗ “ABT-493 also known as glecaprevir” NCT02642432 ↗ “ABT-493 also known as glecaprevir” NCT02604017 ↗ |
| Known as | Epclusa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03549312 ↗ |
| Known as | GLE | “Mavyret, a combination medication of glecaprevir (GLE) and pibrentasvir (PIB), is approved to treat chronic and acute hepatitis C virus (HCV) (genotypes 1-6) infection in...” PMID 42189498 ↗ May 20263“Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once...” NCT03219216 ↗ “This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.” NCT04903626 ↗ “glecaprevir/pibrentasvir (GLE/PIB)” NCT04596475 ↗ |
| Known as | glecaprevir (ABT-493) | “glecaprevir (ABT-493)” NCT02723084 ↗ |
| Known as | glecaprevir also known as ABT-493 | “glecaprevir also known as ABT-493” NCT02692703 ↗ |
| Known as | Glecaprevir component of mavyret | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545363 ↗ |
| Known as | glecaprevir-pibrentasvir | “Patients who underwent transplantation with a viraemic donor heart, as determined by nucleic acid testing (NAT), received pre-emptive oral glecaprevir-pibrentasvir before...” PMID 31353243 ↗ Jul 2019 |
| Known as | Mavyret | “Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret.” NCT03382847 ↗ |
| Known as | SOF/VEL | “The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic...” NCT02346721 ↗ |
| Known as | Sofosbuvir-velpatasvir | “Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection.” PMID 31216086 ↗ Aug 2019 |
| Action | Inhibit | “ABT-493 is a hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor” PMID 26711747 ↗ Dec 2015 |
| Modality | Other / unclassified | “Direct-acting antiviral treatment for HCV” NCT02743897 ↗ |
| Route | Oral | “once-daily, all-oral, pangenotypic treatment” PMID 28412293 ↗ Apr 2017 |