voxilaprevir

Trade name: Vosevi

Small moleculeapproved

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

Phase 1
4
Phase 2
12
Phase 3
6
Phase 4
5

Earliest trial started Jun 1, 2014 (NCT02185794)

Timeline

2010s

  1. Jan 1, 2014

    Gilead Sciences — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2015

    Gilead Sciences — Earliest Phase 3 Sponsor(trial)

  4. Jul 18, 2017

    Earliest FDA Approval

  5. Jul 18, 2017

    Gilead Sciences — NDA Secondary Org

  6. Sep 1, 2017

    Gilead Sciences — First NDA Organization

  7. Sep 1, 2017

    Gilead Sciences — NDA Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewJul 18, 2017

Chemistry & pharmacology

Loading structure…

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

Also known as

  • gs-9857
  • gs-9857
  • gs-9857
  • sofosbuvir / velpatasvir / voxilaprevi
  • vosevi
  • vosevi
  • voxilaprevir
  • voxilaprevir
  • voxilaprevir
  • voxilaprevir
  • voxilaprevir
  • voxilaprevir

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05467826Phase 4Sep 1, 2022Peking University
NCT04695769Phase 4Nov 21, 2020Helwan University
NCT04211909Phase 3Dec 31, 2019Gilead Sciences
NCT03888729Phase 4May 31, 2019Harvard University, Partners in Health
NCT03820258Phase 2Jan 28, 2019Gilead Sciences
NCT03619837Phase 4Jul 15, 2018University of California, San Francisco
NCT03118843Phase 3Apr 25, 2017Gilead Sciences
NCT02938013Phase 4Jan 1, 2017Johns Hopkins University
NCT02745535Phase 2Mar 1, 2016Gilead Sciences, Unity Health Care, Inc., University of Maryland
NCT02639247Phase 3Dec 1, 2015Gilead Sciences
NCT02639338Phase 3Dec 1, 2015Gilead Sciences
NCT02607800Phase 3Nov 1, 2015Gilead Sciences
NCT02607735Phase 3Nov 1, 2015Gilead Sciences
NCT02533427Phase 1Oct 1, 2015Gilead Sciences
NCT02536313Phase 2Jul 1, 2015Gilead Sciences
NCT02402452Phase 1May 1, 2015Gilead Sciences
NCT02397707Phase 1Mar 1, 2015Gilead Sciences
NCT02378961Phase 2Feb 1, 2015Gilead Sciences
NCT02378935Phase 2Feb 1, 2015Gilead Sciences
NCT02202980Phase 2Aug 1, 2014Gilead Sciences
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit161532014
Harvard UniversityAcademic/Hospital1012019
Helwan UniversityAcademic/Hospital1112020
Johns Hopkins UniversityAcademic/Hospital1112017
Partners in HealthAcademic/Hospital1112019
Peking UniversityAcademic/Hospital1112022
Unity Health Care, Inc.Academic/Hospital1012016
University of California, San FranciscoAcademic/Hospital1112018
University of MarylandAcademic/Hospital1112016
9 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitNDA2Jul 18, 2017
Gilead SciencesFor profitNDASep 1, 2017