Drugs / dasabuvir
dasabuvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Exviera | — | 2024-09-25 | europa.eu ↗ |
| Approved | EU (EMA) | Exviera | — | 2015-01-14 | europa.eu ↗ |
| Approved | US (FDA) | VIEKIRA PAK (COPACKAGED) | — | 2014-12-19 | fda.gov ↗ |
Trials 49 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02534870 | Sep 2015 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02052349 | Nov → Dec 2013 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00919490 | Jun → Aug 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00768690 | Oct 2008 → Feb 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00696904 | Jun 2008 → Feb 2009 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT02194998 | Sep 2015 → May 2018 | HIV infectious disease, chronic hepatitis C virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT02356562 | Feb 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01911845 | Apr → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01782495 | Feb 2013 → Nov 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01464827 | Oct 2011 → Mar 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01074008 | Mar 2010 → Jun 2011 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00851890 | Mar → Jul 2009 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02486406 | Oct 2015 → Nov 2020 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2/3 | NCT02555943 | Feb 2015 → May 2021 | chronic hepatitis C virus infection, hepatitis B virus infection | Humanity and Health Research Centre | Completed | No outcome recorded |
| Phase 2/3 | NCT01939197 | Aug 2013 → Jul 2016 | HIV infectious disease, chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 326 trials | ||||||
| Phase 3 | NCT02634008 | Jun 2016 → Apr 2021 | acute hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 3 | NCT02646111 | Jan 2016 → Jan 2018 | chronic hepatitis C virus infection | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02582632 | Nov 2015 → Aug 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02609659 | Oct 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02487199 | Sep 2015 → Dec 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02517528 | Jul 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02517515 | Jul 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02504099 | Jul 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Terminated | No outcome recorded |
| Phase 3 | NCT02476617 | Jun 2015 → Aug 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02442284 | May 2015 → Aug 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02442271 | Apr 2015 → Jul 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02399345 | Mar → Nov 2015 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219477 | Nov 2014 → Jun 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219490 | Oct 2014 → May 2021 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02207088 | Sep 2014 → Dec 2016 | chronic hepatitis C virus infection, cirrhosis of liver, end stage renal failure | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02216422 | Sep 2014 → Dec 2015 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219503 | Sep 2014 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02167945 | Jun 2014 → May 2021 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01854528 | Jun 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01854697 | Mar 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01833533 | Mar → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01767116 | Dec 2012 → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01715415 | Nov 2012 → Nov 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01716585 | Nov 2012 → Oct 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01704755 | Oct 2012 → Jan 2014 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01674725 | Aug 2012 → Jan 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT03003338 | Oct 2017 → Oct 2018 | chronic hepatitis C virus infection | Hannover Medical School | Terminated | No outcome recorded |
| Phase 4 | NCT03050905 | Jun → Nov 2017 | hepatitis C virus infection | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| Phase 4 | NCT02874066 | Mar 2017 → Oct 2018 | viral hepatitis | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02946034 | Feb 2017 → Sep 2020 | chronic hepatitis C virus infection, chronic kidney disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02950870 | Dec 2016 → Dec 2017 | chronic hepatitis C virus infection | University of Modena and Reggio Emilia | Unknown | No outcome recorded |
| Phase 4 | NCT02498015 | Aug 2016 → Aug 2017 | chronic hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT03710252 | Mar 2016 → Sep 2017 | chronic hepatitis C virus infection | American Research Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02460133 | Jul 2015 → Oct 2025 overdue | hepatitis C virus infection | Nova Scotia Health Authority | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00909636 Comparator | May → Jul 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00895102 Comparator | Apr → Jun 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT02493855 Background | Jun 2015 → Apr 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01995071 Background | Nov 2013 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01563536 Background | Feb → Apr 2012 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01306617 Background | Feb → Nov 2011 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00726882 Background | Aug 2008 → May 2010 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01773070 Background | Jun 2013 → Oct 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02786537 Comparator | Jun 2016 → Jun 2019 | chronic hepatitis C virus infection | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02734173 Comparator | Jul 2015 → Feb 2017 | hepatitis C virus infection | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02461745 Comparator | Jun 2015 → May 2017 | chronic hepatitis C virus infection | Kaiser Permanente | Completed | No outcome recorded |
Press releases naming this drug 19 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-02-27 | AbbVie | AbbVie Receives CHMP Positive Opinion for Eight-Week Treatment Option with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C abbvie.com ↗ |
| 2016-09-23 | AbbVie | AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C abbvie.com ↗ |
| 2016-07-25 | AbbVie | AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗ |
| 2016-04-25 | AbbVie | AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗ |
| 2016-04-15 | AbbVie | AbbVie Announces Real-World Data with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) from Large German Hepatitis C-Registry abbvie.com ↗ |
| 2016-04-14 | AbbVie | AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treatment in Genotype 1 Chronic Hepatitis C Patients abbvie.com ↗ |
| 2016-03-30 | AbbVie | AbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) and Investigational, Pan-Genotypic Regimen at The International Liver Congress™ 2016 abbvie.com ↗ |
| 2016-02-26 | AbbVie | AbbVie Receives CHMP Positive Opinion for VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis (Child-Pugh A) in abbvie.com ↗ |
| 2016-01-07 | AbbVie | FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis abbvie.com ↗ |
| 2015-12-02 | AbbVie | AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection abbvie.com ↗ |
| 2015-11-14 | AbbVie | AbbVie Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Patients with Chronic Hepatitis C Virus Infection With or Without Compensated Cirrhosis abbvie.com ↗ |
| 2015-10-22 | AbbVie | AbbVie Updates U.S. Labels for VIEKIRA PAK® and TECHNIVIE™ abbvie.com ↗ |
| 2015-10-01 | AbbVie | AbbVie Demonstrates Commitment to Hepatitis C Patients with New Data on VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) and Ongoing Clinical Development Program at The Liver Meeting® 2015 abbvie.com ↗ |
| 2015-09-11 | AbbVie | Ongoing Real World Study Reports High Sustained Viral Response Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Genotype 1 Hepatitis C Patients abbvie.com ↗ |
| 2015-04-25 | AbbVie | AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX® + EXVIERA® in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress™ 2015 abbvie.com ↗ |
| 2015-02-23 | AbbVie | Results from AbbVie's Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) Published Online in JAMA; Sub-analyses to be Presented at the Annual Confere abbvie.com ↗ |
| 2015-01-16 | AbbVie | European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Chronic Hepatitis C abbvie.com ↗ |
| 2014-12-19 | AbbVie | AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C abbvie.com ↗ |
| 2014-11-21 | AbbVie | CHMP Grants Positive Opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe abbvie.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dasabuvir | “A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With...” NCT03003338 ↗34“Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.” PMID 29909549 ↗ Feb 2019 “12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.” NCT02646111 ↗ “A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection” NCT02498015 ↗ “Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day” NCT02874066 ↗ “All subjects will receive Dasabuvir (Exviera).” NCT03050905 ↗ “a polymerase inhibitor (ABT-333; Dasabuvir)” NCT02734173 ↗ “ABT-333 (also known as dasabuvir)” NCT01704755 ↗ “ABT-333 also known as dasabuvir” NCT02167945 ↗ “ABT-333 also known as dasabuvir” NCT01833533 ↗ |
| Known as | ABT-333 | “a polymerase inhibitor (ABT-333; Dasabuvir)” NCT02734173 ↗26“dasabuvir also known as ABT-333” NCT02517515 ↗ |
| Known as | ABT-333 also known as dasabuvir | “ABT-333 also known as dasabuvir” NCT01715415 ↗7“ABT-333 also known as dasabuvir” NCT01767116 ↗ “ABT-333 also known as dasabuvir” NCT01995071 ↗ “ABT-333 also known as dasabuvir” NCT01674725 ↗ “ABT-333 also known as dasabuvir” NCT02219490 ↗ “ABT-333 also known as dasabuvir” NCT01854697 ↗ “ABT-333 also known as dasabuvir” NCT01716585 ↗ “ABT-333 also known as dasabuvir” NCT01854528 ↗ |
| Known as | ABT-333 also known as Exviera | “ABT-333 also known as Exviera” NCT02219490 ↗ |
| Known as | ABT-333 SODIUM MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137312 ↗ |
| Known as | dasabuvir also known as ABT-333 | “dasabuvir also known as ABT-333” NCT01782495 ↗5“dasabuvir also known as ABT-333” NCT02442284 ↗ “dasabuvir also known as ABT-333” NCT02399345 ↗ “dasabuvir also known as ABT-333” NCT02504099 ↗ “dasabuvir also known as ABT-333” NCT02609659 ↗ “dasabuvir also known as ABT-333” NCT02442271 ↗ |
| Known as | Dasabuvir sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137312 ↗ |
| Known as | DASABUVIR SODIUM MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137312 ↗ |
| Known as | DSV | “Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day” NCT02874066 ↗1“Dasabuvir (DSV)” NCT02194998 ↗ |
| Known as | Exviera | “Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day” NCT02874066 ↗2“All subjects will receive Dasabuvir (Exviera).” NCT03050905 ↗ “ABT-333 also known as Exviera” NCT02167945 ↗ |
| Known as | Viekira Pak | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02946034 ↗ |
| Action | Inhibit | “an experimental Hepatitis C virus (HCV) polymerase inhibitor” NCT00895102 ↗ |
| Modality | Small molecule | — CHEMBL3137312 ↗ |
| Route | Oral | “oral doses of ABT-333” NCT00919490 ↗ |