Drugs / pibrentasvir
pibrentasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MAVYRET | — | 2017-08-03 | fda.gov ↗ |
| Approved | EU (EMA) | Maviret | — | 2017-07-26 | europa.eu ↗ |
Trials 37 · a red edge is where a trial was stopped
| 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| Phase 0 | NCT03702218 | Jul 2019 | hepatitis C virus infection | University of Maryland, Baltimore | Withdrawn | No outcome recorded |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 | ||||||
| Phase 3 | NCT04903626 | Aug 2021 → Sep 2024 | acute hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04017338 | Aug 2018 → Dec 2020 | disease related to solid organ transplantation, hepatitis C virus infection | Jordan Feld | Unknown | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02636595 | Nov 2015 → Oct 2016 | 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 | 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 |
| Phase 4 | NCT04515797 | May 2021 → Aug 2023 | chronic kidney disease, hepatitis C virus infection, kidney failure | Massachusetts General Hospital | Terminated | No outcome recorded |
| 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 |
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 25 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 ↗ |
| 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 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 NCT02651194 ↗ |
| Known as | ABT-530 also known as pibrentasvir | “ABT-530 also known as pibrentasvir” NCT02604017 ↗5“ABT-530 also known as pibrentasvir” NCT02640482 ↗ “ABT-530 also known as pibrentasvir” NCT02640157 ↗ “ABT-530 also known as pibrentasvir” NCT02636595 ↗ “ABT-530 also known as pibrentasvir” NCT02642432 ↗ “ABT-530 also known as pibrentasvir” NCT02738138 ↗ |
| 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 |