Drugs / pibrentasvir
pibrentasvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 1 milestone | |||||
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2017-01-24 | “AbbVie’s marketing authorization application (MAA) for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all...” 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| Phase 0 | NCT03702218 | Jul 2019 | hepatitis C virus infection | University of Maryland, Baltimore | Withdrawn | No outcome recorded |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 | NCT02640157 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT02651194 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| 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 · 22
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 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.* |
| 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. |
| 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 ↗ |
| 2017-01-24 | 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 | 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 | 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) |
| 2016-04-16 | 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 |
All press releases naming this drug 40 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pibrentasvir | “Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks...” NCT03627299 ↗28“glecaprevir and pibrentasvir are hepatitis C virus (HCV) pangenotypic inhibitors targeting NS3/4A protease and NS5A, respectively.” PMID 29180522 ↗ Jan 2018 “pangenotypic DAA regimen of glecaprevir and pibrentasvir (G/P)” PMID 30977945 ↗ May 2019 “Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6” NCT03702218 ↗ “ABT-530 also known as pibrentasvir” NCT02446717 ↗ “ABT-530 also known as pibrentasvir” NCT02651194 ↗ “ABT-530 also known as pibrentasvir” NCT02642432 ↗ |
| Known as | A-1325912.0 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545123 ↗ |
| Known as | ABT-530 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02640157 ↗ |
| Known as | ABT-530 also known as pibrentasvir | “ABT-530 also known as pibrentasvir” NCT02642432 ↗5“ABT-530 also known as pibrentasvir” NCT02640157 ↗ “ABT-530 also known as pibrentasvir” NCT02640482 ↗ “ABT-530 also known as pibrentasvir” NCT02738138 ↗ “ABT-530 also known as pibrentasvir” NCT02636595 ↗ “ABT-530 also known as pibrentasvir” NCT02604017 ↗ |
| Known as | PIB | “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 | pibrentasvir (ABT-530) | “pibrentasvir (ABT-530)” NCT02723084 ↗ |
| Known as | pibrentasvir also known as ABT-530 | “pibrentasvir also known as ABT-530” NCT02692703 ↗ |
| Known as | Pibrentasvir component of mavyret | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545123 ↗ |
| Action | Inhibit | “ABT-530 is an HCV NS5A 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 |