voxilaprevir
Trade name: Vosevi
Approved
Jul 18, 2017
Voxilaprevir is a Direct-Acting Antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). Sofosbuvir/velpatasvir/voxilaprevir (Vosevi) is indicated for adult patients with chronic HCV without cirrhosis or with compensated cirrhosis who have (1) genotype 1 through 6 and have previously been treated with an NS5A inhibitor or (2) genotype 1a or 3 and have previously been treated with sofosbuvir without an NS5A inhibitor. Voxilaprevir exerts its antiviral action by reversibley binding and inhibiting the NS3/4A serine protease of Hepatitis C Virus (HCV). Following viral replication of HCV genetic material and translation into a single polypeptide, Nonstructural Protein 3 (NS3) and its activating cofactor Nonstructural Protein 4A (NS4A) are responsible for cleaving genetic material into the following structural and nonstructural proteins required for assembly into mature virus: NS3, NS4A, NS4B, NS5A, and NS5B. By inhibiting viral protease NS3/4A, voxilaprevir therefore prevents viral replication and function. — NCATS
Clinical trial activity
21 trials · 9 clinical orgs · 1 marketing orgs
Earliest trial started Jun 1, 2014 (NCT02185794)
Timeline
2010s
- Jan 1, 2014
Gilead Sciences — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Gilead Sciences — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2015
Gilead Sciences — Earliest Phase 3 Sponsor(trial)
- Jul 18, 2017
Earliest FDA Approval
- Jul 18, 2017
Gilead Sciences — NDA Secondary Org
- Sep 1, 2017
Gilead Sciences — First NDA Organization
- Sep 1, 2017
Gilead Sciences — NDA Organization
Indications
Approved for
Mechanism of action
Hepatitis C virus serine protease, NS3/NS4A inhibitor
Combination products
vosevi
with sofosbuvir, velpatasvir
Also known as sofosbuvir, velpatasvir and voxilaprevir
Approval history
- approvedPriority reviewJul 18, 2017
Chemistry & pharmacology
SMILES
CC[C@@H]1[C@@H]2CN([C@@H]1C(=O)N[C@@]3(C[C@H]3C(F)F)C(=O)NS(=O)(=O)C4(C)CC4)C(=O)[C@@H](NC(=O)O[C@@H]5C[C@H]5CCCCC(F)(F)C6=C(O2)N=C7C=C(OC)C=CC7=N6)C(C)(C)C- Mol. weight
- 868.934 g/mol
- Lipinski Ro5
- 3 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
- WikipediaVoxilaprevir ↗
- NCATS0570F37359 ↗
- ChEMBLCHEMBL3707372 ↗
Also known as
- gs-9857
- gs-9857
- gs-9857
- sofosbuvir / velpatasvir / voxilaprevi
- vosevi
- vosevi
- voxilaprevir
- voxilaprevir
- voxilaprevir
- voxilaprevir
- voxilaprevir
- voxilaprevir
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05467826 | Phase 4 | Sep 1, 2022 | Peking University |
| NCT04695769 | Phase 4 | Nov 21, 2020 | Helwan University |
| NCT04211909 | Phase 3 | Dec 31, 2019 | Gilead Sciences |
| NCT03888729 | Phase 4 | May 31, 2019 | Harvard University, Partners in Health |
| NCT03820258 | Phase 2 | Jan 28, 2019 | Gilead Sciences |
| NCT03619837 | Phase 4 | Jul 15, 2018 | University of California, San Francisco |
| NCT03118843 | Phase 3 | Apr 25, 2017 | Gilead Sciences |
| NCT02938013 | Phase 4 | Jan 1, 2017 | Johns Hopkins University |
| NCT02745535 | Phase 2 | Mar 1, 2016 | Gilead Sciences, Unity Health Care, Inc., University of Maryland |
| NCT02639247 | Phase 3 | Dec 1, 2015 | Gilead Sciences |
| NCT02639338 | Phase 3 | Dec 1, 2015 | Gilead Sciences |
| NCT02607800 | Phase 3 | Nov 1, 2015 | Gilead Sciences |
| NCT02607735 | Phase 3 | Nov 1, 2015 | Gilead Sciences |
| NCT02533427 | Phase 1 | Oct 1, 2015 | Gilead Sciences |
| NCT02536313 | Phase 2 | Jul 1, 2015 | Gilead Sciences |
| NCT02402452 | Phase 1 | May 1, 2015 | Gilead Sciences |
| NCT02397707 | Phase 1 | Mar 1, 2015 | Gilead Sciences |
| NCT02378961 | Phase 2 | Feb 1, 2015 | Gilead Sciences |
| NCT02378935 | Phase 2 | Feb 1, 2015 | Gilead Sciences |
| NCT02202980 | Phase 2 | Aug 1, 2014 | Gilead Sciences |
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Gilead Sciences | For profit | 16 | 15 | 3 | 2014 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Helwan University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Partners in Health | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Peking University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Unity Health Care, Inc. | Academic/Hospital | 1 | 0 | 1 | 2016 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2018 |
| University of Maryland | Academic/Hospital | 1 | 1 | 1 | 2016 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Gilead Sciences | For profit | NDA2 | Jul 18, 2017 |
| Gilead Sciences | For profit | NDA | Sep 1, 2017 |