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velpatasvir

Trade name: Epclusa

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Jun 28, 2016

Velpatasvir (VEL; GS-5816) is an inhibitor of HCV NS5A protein, it demonstrated favourable in vitro and in vivo properties, including potent antiviral activity against hepatitis C virus genotypes 1 to 6 replicon, good metabolic stability, low systemic clearance, and adequate bioavailability and physicochemical properties to warrant clinical evaluation. Velpatasvir is used together with sofosbuvir in the treatment of hepatitis C infection of all six major genotypes. A once-daily, single-tablet, pangenotypic regimen comprising the HCV NS5B polymerase inhibitor sofosbuvir and the HCV NS5A inhibitor velpatasvir (sofosbuvir/ velpatasvir; Epclusa) has recently been approved for the treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection in the USA, EU and Canada. — NCATS

Clinical trial activity

95 trials · 63 clinical orgs · 1 marketing orgs

Phase 1
13
Phase 2
46
Phase 3
21
Phase 4
32

Earliest trial started Nov 1, 2012 (NCT01740791)

Timeline

2010s

  1. Jan 1, 2012

    Gilead Sciences — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2013

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2014

    Gilead Sciences — Earliest Phase 3 Sponsor(trial)

  4. Jun 28, 2016

    Gilead Sciences — Earliest FDA Approval

  5. Jun 28, 2016

    Gilead Sciences — NDA Secondary Org

  6. Jun 28, 2016

    Gilead Sciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewFast trackBreakthroughJun 28, 2016

Chemistry & pharmacology

Loading structure…

SMILES

COC[C@H]1C[C@H](N(C1)C(=O)[C@H](NC(=O)OC)C2=CC=CC=C2)C3=NC=C(N3)C4=CC5=C(C=C4)C6=CC7=C(C=C6OC5)C8=C(C=C7)N=C(N8)[C@@H]9CC[C@H](C)N9C(=O)[C@@H](NC(=O)OC)C(C)C
Mol. weight
883.0019 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

Also known as

  • cdi-31244
  • epclusa
  • epclusa
  • epclusa
  • epclusa
  • gs5816
  • gs-5816
  • gs-5816
  • gs-5816
  • gs-5816
  • gs-5816
  • methyl {(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-4-yl}-1,11-dihydro[2]benzopyrano[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate
  • methyl {(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-4-yl}-1,11-dihydro[2]benzopyrano[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate
  • sofosbuvir / velpatasvir
  • sofosbuvir / velpatasvir
  • sofosbuvir velpatasvir drug combination
  • sofosbuvir-velpatasvir drug combination
  • sofosbuvir, velpatasvir drug combination
  • sofosbuvir / velpatasvir / voxilaprevi
  • velpatasvir
  • velpatasvir
  • velpatasvir
  • velpatasvir
  • velpatasvir
  • velpatasvir
  • velpatasvir
  • velpatasvir
  • velpatsvir

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06953479Phase 4Jun 11, 2025Brown University, National Institute on Drug Abuse (NIDA)
NCT06533319N/AAug 1, 2024Eastern Idaho Public Health
NCT06159504Early Phase 1 (Phase 1)Mar 31, 2024Burnet Institute, Médecins du Monde, UNITAID, University of Bristol
NCT05248919N/AJun 1, 2023Aga Khan University, Dow University of Health Sciences, University of Bristol, University of London, University of Oxford
NCT05467826Phase 4Sep 1, 2022Peking University
NCT06306300Phase 4Jul 4, 2022Conselho Nacional de Desenvolvimento Científico e Tecnológico, Oswaldo Cruz Foundation
NCT05264558Phase 4May 25, 2022Cairns Hospital, University of Queensland
NCT05140941Phase 4Feb 1, 2022Gilead Sciences, University of Pittsburgh
NCT05016609Phase 4Oct 31, 2021Burnet Institute
NCT04997564Phase 4Aug 31, 2021Peking University
NCT04695769Phase 4Nov 21, 2020Helwan University
NCT04653818Phase 4Oct 5, 2020Alexandria University
NCT04382404Phase 1Jul 1, 2020Gilead Sciences, National Institutes of Health (NIH), University of Pittsburgh
NCT04211909Phase 3Dec 31, 2019Gilead Sciences
NCT04075916Phase 2Nov 30, 2019Gilead Sciences, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania
NCT04112303Phase 3Oct 31, 2019Gilead Sciences
NCT03987503Phase 4Sep 30, 2019Gilead Sciences, University of California, San Francisco
NCT03949764Phase 4Aug 21, 2019Gilead Sciences, Icahn School of Medicine at Mount Sinai, National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA), University of Bristol, University of Kentucky
NCT04039698N/AJul 22, 2019Federal University of Health Science of Porto Alegre, Federal University of Rio Grande do Sul, Government of Brazil, State Department of Health of Rio Grande do Sul
NCT03809533Phase 2May 31, 2019University of Pittsburgh
Showing 20 of 95 trials
Page 1 / 5

Organizations

Research & Development (63)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit523842012
University of PittsburghAcademic/Hospital7732017
Harvard UniversityAcademic/Hospital5412017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3222015
University of BristolAcademic/Hospital3032019
University of California, San FranciscoAcademic/Hospital3212017
University of New South WalesAcademic/Hospital3322014
Burnet InstituteAcademic/Hospital2122021
Cocrystal Pharma, Inc.For profit2222016
Johns Hopkins UniversityAcademic/Hospital2112017
National Institute on Drug Abuse (NIDA)Government2012019
Peking UniversityAcademic/Hospital2212021
Radboud UniversityAcademic/Hospital2222018
University of MarylandAcademic/Hospital2112016
University of PennsylvaniaAcademic/Hospital2212018
Aga Khan UniversityAcademic/Hospital1012023
AIDS Clinical Trials GroupAcademic/Hospital1112018
Alexandria UniversityAcademic/Hospital1112020
American University of BeirutAcademic/Hospital1112017
Baylor UniversityAcademic/Hospital1112018
63 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitNDA2Jun 28, 2016
Gilead SciencesFor profitNDAJun 28, 2016