Drugs / glecaprevir
glecaprevir
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 2 milestones | |||||
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2017-01-24 | “has been validated and is now under accelerated assessment by the European Medicines Agency (EMA) for the company's investigational, pan-genotypic regimen of glecaprevir” abbvie.com ↗ “its marketing authorization application was validated and is under accelerated assessment by the European Medicines Agency (EMA)” abbvie.com ↗ “In the EU, the Marketing Authorization Application (MAA) for G/P was validated by the European Medicines Agency” enanta.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2016-12-19 | “In December, AbbVie submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AbbVie's investigational HCV regimen of glecaprevir/pibrentasvir (G/P)” enanta.com ↗ “has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir” abbvie.com ↗ “AbbVie has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, pan-genotypic, fixed-dose combination of glecaprevir” enanta.com ↗ |
| Filed hepatitis C virus infection 1 milestone | |||||
| Filed | Japan (PMDA) | — | hepatitis C virus infection | — | “The NDA for the G/P regimen in Japan was submitted in February 2017.” enanta.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | MAVYRET | — | 2017-08-03 | fda.gov ↗ |
| Approved | EU (EMA) | Maviret | — | 2017-07-26 | europa.eu ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04682509 | Mar 2022 → May 2023 | end stage renal failure | NYU Langone Health | Completed | No outcome recorded |
| Phase 0 | NCT03702218 | Jul 2019 | hepatitis C virus infection | University of Maryland, Baltimore | Withdrawn | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT02442258 | Mar → Dec 2015 | impaired renal function disease | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02296905 | Oct 2014 → Sep 2015 | — | AbbVie | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07040319 | Jun 2026 → Oct 2027 expected | hepatitis C virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04596475 | May 2021 → Apr 2022 | hepatitis C virus infection | University of California, San Diego | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04042740 | Nov 2019 → May 2023 | HIV infectious disease, acute hepatitis C virus infection | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 2 | NCT02243280 | Aug 2014 → Feb 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01995071 | Nov 2013 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT03801707 | Mar 2019 → Apr 2021 | hepatitis C virus infection | Ohio State University | Completed | No outcome recorded |
| Phase 2/3 | NCT03067129 | Mar 2017 → May 2020 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2/3 | NCT02446717 | Apr 2015 → Dec 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2/3 | NCT02243293 | Sep 2014 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 318 trials · 5 met primary · 1 missed | ||||||
| Phase 3 | NCT04903626 | Aug 2021 → Sep 2024 | acute hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT04017338 | Aug 2018 → Dec 2020 | disease related to solid organ transplantation, hepatitis C virus infection | Jordan Feld | Unknown | Met primary |
| Phase 3 | NCT03219216 | Jun 2018 → Mar 2019 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03117569 | Aug 2017 → Dec 2018 | chronic hepatitis C virus infection | Kirby Institute | Completed | Missed primary |
| Phase 3 | NCT03212521 | Aug 2017 → Aug 2018 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03089944 | Apr 2017 → Jul 2019 | hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT03069365 | Mar 2017 → Feb 2018 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02966795 | Jan 2017 → Jun 2018 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02634008 | Jun 2016 → Apr 2021 | acute hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 3 | NCT02738138 | May 2016 → Mar 2017 | HIV infectious disease, chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02692703 | Apr 2016 → Apr 2017 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02723084 | Apr 2016 → Jan 2017 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT02642432 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02651194 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02640157 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT02640482 | Nov 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02636595 | Nov 2015 → Oct 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02604017 | Oct 2015 → Jan 2017 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT05582681 | Nov 2022 → Nov 2024 | hepatitis C virus infection | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04515797 | May 2021 → Aug 2023 | chronic kidney disease, hepatitis C virus infection, kidney failure | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04575896 | Nov 2020 → Nov 2023 | end stage renal failure, hepatitis C virus infection | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT04614142 | Nov 2020 → Aug 2021 | chronic hepatitis C virus infection, end stage renal failure | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT03627299 | Sep 2018 → Dec 2019 | end stage renal failure, hepatitis C virus infection | Johns Hopkins University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03492112 | Sep 2019 → Nov 2021 | hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT02441283 Comparator | Jun 2015 → Oct 2019 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| — | NCT03123965 Background | — | hepatitis C virus infection | AbbVie | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 61
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Meets Both Its Primary and Secondary Endpoints in the Phase 3 C-BEYOND North America Trial Evaluating Bemnifosbuvir/Ruzasvir for Hepatitis C Virus ateapharma.com ↗
BEM/RZR demonstrated statistical non-inferiority compared to the fixed-dose combination of sofosbuvir and velpatasvir (SOF/VEL) in the modified intent-to-treat (mITT) population, achieving the trial’s primary endpoint. |
| 2026-06-23 | AbbVie | Regulatory AbbVie Announces European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus Infection abbvie.com ↗
MAVIRET ® (glecaprevir/pibrentasvir) is now approved in the European Union for the treatment of acute hepatitis C virus (HCV) infection with compensated liver disease (with or without cirrhosis) in adults and children aged 3 years and older. |
| 2026-06-23 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals’ Partner AbbVie Receives European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus enanta.com ↗ |
| 2026-05-22 | AbbVie | Regulatory AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection abbvie.com ↗ |
| 2025-06-11 | AbbVie | Regulatory 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 ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET ® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. |
| 2025-06-11 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals’ Partner AbbVie Receives U.S. FDA Approval of an Expanded Indication for MAVYRET® (glecaprevir/pibrentasvir) as the First and Only Treatment for People with Acute Hepatitis C Virus enanta.com ↗
It is now approved as the only eight-week treatment for adults and pediatric patients three years and older with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.* |
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
The SVR10K Hepatitis C study: Final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe |
| 2023-06-14 | Gilead Sciences | Results Gilead to Present Latest Liver Disease Research at the European Association for the Study of the Liver (EASL) Congress 2023 gilead.com ↗
Among patients with baseline DDI-related comedication use, those initiating treatment with Epclusa ® (sofosbuvir/velpatasvir) were less likely to discontinue their DDI-related comedication prior to DAA initiation than patients initiating treatment with glecaprevir/pibrentasvir. |
| 2021-03-02 | Gilead Sciences | Results Gilead to Present New Data at CROI 2021 Demonstrating the Company's Commitment to Addressing Urgent Global Health Needs gilead.com ↗
HIV treatment research includes long-term data from two Phase 3 studies (Study 1489 and Study 1490) that demonstrated the safety and efficacy profile of the once-daily, single tablet regimen, Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) compared with dolutegravir (DTG)-containing regimens for the treatment of HIV-1 infection in treatment-naïve adults. |
| 2020-03-06 | AbbVie | Regulatory 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 ↗ |
| 2020-03-06 | Enanta Pharmaceuticals, Inc | Regulatory Enanta’s HCV Collaboration Partner AbbVie Receives Marketing Authorization from European Commission to Shorten MAVIRET® (glecaprevir/pibrentasvir) Duration to Eight Weeks for Treatment-Naïve Genotype 3 HCV Patients with Compensated Cirrhosis enanta.com ↗
MAVIRET now available in the EU as an 8-week treatment option for treatment-naïve, chronic hepatitis C virus (HCV) patients without cirrhosis or with compensated cirrhosis, regardless of genotype* |
| 2020-02-04 | Gilead Sciences | Regulatory Gilead Sciences Announces Fourth Quarter and Full Year 2019 Financial Results gilead.com ↗
Approval of Vosevi ® (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) by the China National Medical Products Administration |
| 2020-01-31 | AbbVie | Regulatory 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 ↗
Today's positive CHMP opinion for MAVIRET moves us further toward our goal of providing an effective 8-week therapeutic option with the potential to simplify the treatment journey for the majority of people living with HCV, regardless of disease genotype. |
| 2019-09-26 | AbbVie | Regulatory 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 ↗
This approval provides more HCV patients an option to treat their disease in as little as 8 weeks. |
| 2019-08-02 | AbbVie | Regulatory 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 ↗ |
| 2019-08-02 | Enanta Pharmaceuticals, Inc | Regulatory Enanta’s HCV Collaboration Partner AbbVie receives Approval by the European Commission for MAVIRET™ (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve HCV Patients with Compensated Cirrhosis enanta.com ↗
MAVIRET™ is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5 or 6 |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗ |
| 2019-01-08 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) gilead.com ↗ |
| 2018-11-13 | AbbVie | Results AbbVie's MAVYRET™ (glecaprevir/pibrentasvir) Shows High Virologic Cure* Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗
Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR 12 ) per protocol analysis. |
| 2018-11-13 | Enanta Pharmaceuticals, Inc | Results Enanta Announces that AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir) Shows High Virologic Cure* Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis enanta.com ↗
Results from AbbVie’s Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) per protocol analysis.1 |
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis (late-breaking poster #LB-15) |
| 2018-07-25 | Gilead Sciences | Regulatory Gilead Sciences Announces Second Quarter 2018 Financial Results gilead.com ↗
Announced that the China Drug Administration (CDA) has approved Epclusa for the treatment of adults with genotype 1-6 HCV infection. |
| 2018-05-30 | Gilead Sciences | Regulatory China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Drug Administration (CDA) has approved Epclusa ® (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
| 2017-11-30 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces That AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) Is Now Available in Japan for the Treatment of Chronic Hepatitis C Across All Major Genotypes (GT1-6) enanta.com ↗ |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection |
| 2017-09-27 | AbbVie | Regulatory AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in Japan abbvie.com ↗
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved MAVIRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). |
| 2017-09-27 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces that AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) Received Approval in Japan for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C enanta.com ↗
MAVIRET is the first and only 8-week treatment approved in Japan for genotype 1 and 2 hepatitis C virus (HCV) infected patients without cirrhosis and who are new to DAA treatment* |
| 2017-08-03 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces U.S. FDA Approval of AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in as Little as 8 Weeks enanta.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). |
| 2017-08-01 | Gilead Sciences | Regulatory 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 | Regulatory 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 ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). |
| 2017-06-23 | AbbVie | Regulatory 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 | Enanta Pharmaceuticals, Inc | Results Enanta Announces Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic, Ribavirin-Free HCV Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates in Challenging-to-Treat Genotype 3 Chronic HCV Patients enanta.com ↗
In results from AbbVie’s Phase 3 ENDURANCE-3 study, 95 percent (n=149/157) of GT3 chronic HCV-infected patients without cirrhosis and who were new to treatment achieved sustained virologic response at 12 weeks post-treatment (SVR12) following 8 weeks of treatment with G/P. |
| 2017-04-20 | AbbVie | Results 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 ↗
SVR 12 was achieved by 145/146 (99 percent) patients, with one GT1a-infected patient experiencing relapse. |
| 2017-04-20 | Enanta Pharmaceuticals, Inc | Results Enanta Announces 99 Percent SVR12 Rate in Chronic HCV Patients with Compensated Cirrhosis Treated with AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that 99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with AbbVie’s investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P). |
| 2017-03-14 | AbbVie | Regulatory 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 ↗
We are pleased that G/P has now been recognized as a potential important therapy for people living with HCV through the receipt of priority review designations by regulatory authorities in Japan , the EU and the U.S. |
| 2017-03-14 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces Japanese Ministry of Health, Labour and Welfare Grants Priority Review for AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C enanta.com ↗ |
| 2017-02-02 | AbbVie | Regulatory 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 ↗ |
| 2017-02-02 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) enanta.com ↗ |
| 2017-01-24 | AbbVie | Regulatory 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 ↗
We are pleased at the potential of our investigational, pan-genotypic regimen and that it has been granted accelerated assessment by the EMA. |
| 2017-01-24 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces EMA Grants Accelerated Assessment, Validates Marketing Authorization Application for AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C enanta.com ↗ |
| 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 ↗
In top-line results from the Phase 3 CERTAIN-1 study, 99 percent (n=105/106) of patients without cirrhosis, which represents the majority of HCV patients, and without the Y93H variant achieved sustained virologic response at 12 weeks post treatment (SVR 12 ). |
| 2017-01-09 | Enanta Pharmaceuticals, Inc | Results Enanta Announces High SVR12 Rates Achieved in Genotype 1 Chronic HCV Infected Japanese Patients with Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) enanta.com ↗
Top-line results from the study demonstrated 99 percent (n=105/106) of patients without cirrhosis, who represent the majority of HCV patients, and without the Y93H variant, achieved sustained virologic response at 12 weeks after treatment (SVR12). |
| 2016-12-19 | AbbVie | Regulatory 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 ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV). |
| 2016-12-19 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces AbbVie’s Submission of NDA for Investigational, Pan-Genotypic HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Genotypes 1 through 6 of Chronic Hepatitis C Virus (HCV) enanta.com ↗
today announced that AbbVie has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, pan-genotypic, fixed-dose combination of glecaprevir (ABT-493) and pibrentasvir (ABT-530) (G/P), being evaluated for the treatment of chronic HCV. |
| 2016-11-15 | AbbVie | Results 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 ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR 12 ) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. |
| 2016-11-15 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces 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 enanta.com ↗
In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients. |
| 2016-11-11 | AbbVie | Results 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 ↗
In more than 700 genotype 1-6 (GT1-6) chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR 12 ), regardless of baseline viral load. |
| 2016-11-11 | Enanta Pharmaceuticals, Inc | Results Enanta Announces 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 enanta.com ↗
In more than 700 chronic HCV patients without cirrhosis who were infected with one of genotypes 1-6 (GT1-6) and were new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR12), regardless of baseline viral load. |
| 2016-09-30 | AbbVie | Regulatory AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor. |
| 2016-09-30 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation enanta.com ↗
Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs) |
| 2016-06-28 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗ |
| 2016-04-16 | AbbVie | Results 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 ↗
No patients discontinued treatment due to adverse events. |
| 2016-04-16 | Enanta Pharmaceuticals, Inc | Results Enanta Announces New Data from AbbVie’s SURVEYOR-1 and SURVEYOR-2 Studies Showing High Sustained Virologic Response Rates after 8 or 12 Weeks of Treatment in Patients with any of Genotypes 1 through 6 of Hepatitis C Virus enanta.com ↗
97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 treatment in genotypes 1, 2 or 3 HCV patients without cirrhosis in SURVEYOR 1 and 2 studies1,2 |
| 2016-04-15 | AbbVie | Results 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 ↗
SVR 12 was achieved in 95 percent of patients with and without RBV (n=20/21, n=19/20; respectively) in a modified intent-to-treat analysis, excluding patients who did not achieve SVR for reasons other than virologic failure. |
| 2016-04-15 | Enanta Pharmaceuticals, Inc | Results Enanta Announces that 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 enanta.com ↗
Additionally, 86 percent (n=19/22) of GT1 patients who received ABT-493 and ABT-530 without RBV, achieved SVR12. |
| 2015-11-16 | AbbVie | Results AbbVie Announces High Sustained Virologic Response Rates in Phase 2 Studies with Pan-genotypic, Investigational Regimen in Patients with Chronic Hepatitis C abbvie.com ↗
After 12 weeks of treatment, SVR 12 rates achieved were 97-100 percent in genotype 1 (GT1), 96-100 percent in genotype 2 (GT2) and 83-94 percent in genotype 3 (GT3) patients. |
| 2015-11-16 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Investigational Regimen Containing Enanta’s Next-Generation Protease Inhibitor ABT-493 Demonstrates High Sustained Virologic Response Rates in Phase 2 Studies in Patients with Chronic Hepatitis C enanta.com ↗
Separately, in a late-breaking presentation of the SURVEYOR-1 trial, additional data will show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR12 rate of 97 percent. |
| 2015-04-08 | AbbVie | Results AbbVie to Present New Data from Hepatitis C Clinical Development Program at The International Liver Congress™ 2015 abbvie.com ↗
Preliminary results from a Phase 2b study (n=79) of ABT-493 and ABT-530 in non-cirrhotic GT1 patients receiving the RBV-free recommended regimen for 12 weeks demonstrated a sustained virologic response rate at four weeks post treatment (SVR 4 ) of 99 percent (n=78/79). |
| 2015-04-08 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Data Presentations on Regimens Containing Protease Inhibitors Paritaprevir and ABT-493 at The International Liver Congress™ 2015 enanta.com ↗
Preliminary SVR4 Data of 99 percent Announced on Phase 2b regimens containing ABT-493 and ABT-530 |
| 2014-03-04 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces New Data Presented on Protease Inhibitor ABT-493 at the 21st Conference on Retroviruses and Opportunistic Infections (CROI) enanta.com ↗
In vitro ABT-493 retains potency against most of the clinically important resistance-associated variants in genotype 1 and is fully active against variants resistant to NS5A or NS5B inhibitors. |
All press releases naming this drug 67 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 45 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” NCT02651194 ↗ “ABT-493 also known as glecaprevir” NCT02446717 ↗ “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 NCT02636595 ↗ |
| Known as | ABT-493 also known as glecaprevir | “ABT-493 also known as glecaprevir” NCT02604017 ↗5“ABT-493 also known as glecaprevir” NCT02640482 ↗ “ABT-493 also known as glecaprevir” NCT02642432 ↗ “ABT-493 also known as glecaprevir” NCT02738138 ↗ “ABT-493 also known as glecaprevir” NCT02636595 ↗ “ABT-493 also known as glecaprevir” NCT02640157 ↗ |
| 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 ↗ |
| Action | Inhibit | “ABT-493 is a hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor” PMID 26711747 ↗ Dec 2015 |
| Modality | Other / unclassified | “approved direct-acting antivirals (DAAs) Glecaprevir/Pibrentasvir (G/P)” NCT04017338 ↗ |
| Route | Oral | “once-daily, all-oral, pangenotypic treatment” PMID 28412293 ↗ Apr 2017 |