elbasvir
Small moleculeapprovedBreakthrough Therapy FDA
Approved
Jan 28, 2016
Elbasvir is an inhibitor of the Hepatitis C Virus (HCV) Non-Structural protein 5A (NS5A). Elbasvir was approved by the FDA in January 2016 for the treatment of hepatitis C. It was developed by Merck and completed Phase III trials, used in combination with the NS3/4A protease inhibitor grazoprevir under the trade name Zepatier. Zepatier is indicated for treatment of chronic HCV genotype 1 or 4 infection in adults. — NCATS
Clinical trial activity
64 trials · 56 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
32
Phase 3
22
Phase 4
22
Earliest trial started Feb 1, 2012 (NCT01532973)
Timeline
Indications
Approved for
Studied for
- Carcinoma, Hepatocellular · Phase 3
- Cardiovascular Diseases · Phase 4
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Cross Infection · Phase 4
- Deglutition Disorders · Phase 1
- Heart Transplantation · Phase 4
- Hepacivirus · Phase 2/Phase 3
- Hepatic Insufficiency · Phase 1
- Hepatitis C · Phase 4
- Hepatitis, Viral, Human · Phase 1
- HIV · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 4
- Liver Cirrhosis · Phase 3
- Liver Transplantation · Phase 4
- Lung Diseases · Phase 1/Phase 2
- Metabolic Syndrome · Phase 3
- Renal Dialysis · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Substance Abuse, Intravenous · Phase 4
- Substance-Related Disorders · Phase 4
Mechanism of action
- Nonstructural protein 5AINHIBITOR
NS5A inhibitor
Combination products
zepatier
with grazoprevir
Also known as elbasvir and grazoprevir
Approval history
- approvedPriority reviewBreakthroughJan 28, 2016
Chemistry & pharmacology
Loading structure…
SMILES
COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C2=NC=C(N2)C3=CC4=C(C=C3)N5[C@@H](OC6=C(C=CC(=C6)C7=CN=C(N7)[C@@H]8CCCN8C(=O)[C@@H](NC(=O)OC)C(C)C)C5=C4)C9=CC=CC=C9- Mol. weight
- 882.0171 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaElbasvir ↗
- NCATS632L571YDK ↗
- ChEMBLCHEMBL3039514 ↗
Also known as
- 2-(pyrrolidin-2-yl)-5-(2-(4-(5-(pyrrolidin-2-yl)-1h-imidazol-2-yl)phenyl)benzofuran-5-yl)-1h-imidazole
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir
- elbasvir / grazoprevir
- mk8742
- mk8742
- mk 8742
- mk-8742
- mk-8742
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04546802 | Phase 3 | Sep 30, 2019 | Merck, Monash University, University of Melbourne |
| NCT03797066 | Phase 4 | Apr 30, 2019 | Hepatitis C Trust, Merck, University of London |
| NCT03817619 | Phase 1 | Mar 28, 2019 | Radboud University |
| NCT03723824 | Phase 4 | Feb 14, 2019 | Taichung Veterans General Hospital |
| NCT03791814 | Phase 4 | Jan 31, 2019 | Davita Clinical Research, Merck, Yeshiva University |
| NCT03724149 | Phase 1/Phase 2 (Phase 2) | Dec 12, 2018 | Merck, University of Pennsylvania |
| NCT03381859 | Phase 4 | Dec 1, 2018 | Cairo University, Merck, University of Maryland |
| NCT03365635 | Phase 4 | Dec 1, 2018 | Merck, University of Pennsylvania |
| NCT03823911 | Phase 4 | Nov 18, 2018 | Merck, National Institutes of Health (NIH), University of Maryland |
| NCT03585101 | Phase 4 | Aug 31, 2018 | Merck, University of California, Los Angeles |
| NCT03420300 | Phase 4 | Jun 5, 2018 | National Taiwan University |
| NCT03496233 | Phase 3 | Apr 30, 2018 | University of Palermo |
| NCT03379506 | Phase 2 | Jan 25, 2018 | Merck |
| NCT03236506 | Phase 2 | Jan 19, 2018 | University of Dundee |
| NCT03359746 | Phase 4 | Dec 15, 2017 | King Faisal University, Merck |
| NCT03222167 | Phase 3 | Oct 31, 2017 | Institute Of Cardiology & Internal Diseases, Kazakhstan, Merck, Synergy Research |
| NCT03221582 | Phase 4 | Aug 28, 2017 | Department of Veteran Affairs, Merck |
| NCT03249194 | Early Phase 1 (Phase 1) | Aug 17, 2017 | Virginia Commonwealth University |
| NCT03093740 | Phase 4 | Jul 1, 2017 | Harvard University |
| NCT03026023 | Phase 4 | Jul 1, 2017 | Harvard University, Merck |
Showing 20 of 64 trials
Page 1 / 4
Organizations
Research & Development (56)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 47 | 23 | 5 | 2012 |
| Harvard University | Academic/Hospital | 3 | 3 | 1 | 2017 |
| University of Maryland | Academic/Hospital | 3 | 3 | 1 | 2017 |
| University of Pennsylvania | Academic/Hospital | 3 | 3 | 2 | 2016 |
| University of Barcelona | Academic/Hospital | 2 | 2 | 1 | 2016 |
| AbbVie | For profit | 1 | 0 | 1 | 2016 |
| Cairo University | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2016 |
| CD Pharma Group S.r.l. | For profit | 1 | 0 | 1 | 2016 |
| Celerion | For profit | 1 | 0 | 1 | 2013 |
| CH PERPIGNAN | Academic/Hospital | 1 | 0 | 1 | 2016 |
| CHU Henri Mondor | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Chulalongkorn University | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Davita Clinical Research | For profit | 1 | 0 | 1 | 2019 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2017 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Eurofins | For profit | 1 | 0 | 1 | 2016 |
| French National Agency for Research on AIDS and Viral Hepatitis | Government | 1 | 1 | 1 | 2016 |
| Hepatitis C Trust | Academic/Hospital | 1 | 0 | 1 | 2019 |
| HIV-NAT Thai Red Cross AIDS Research Center | Academic/Hospital | 1 | 0 | 1 | 2017 |
56 organizations
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