CDEK
← All drugs Report issue

tenofovir alafenamide

Trade name: genvoya

Small moleculeapprovedFast Track FDA

Approved

Nov 5, 2015

Tenofovir alafenamide, sold under the brand name Vemlidy, is an antiviral medication used against hepatitis B and HIV. It is used for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and is given in combination with other medications for the prevention and treatment of HIV. It is taken by mouth. — Wikipedia

Clinical trial activity

218 trials · 216 clinical orgs · 10 marketing orgs

Phase 1
38
Phase 2
80
Phase 3
40
Phase 4
78

Earliest trial started Mar 1, 2002 (NCT00036634)

Timeline

2000s

  1. Jan 1, 2002

    Gilead Sciences — Earliest Phase 1 Sponsor(trial)

2010s

  1. Nov 5, 2015

    Gilead Sciences — Earliest FDA Approval

  2. Nov 5, 2015

    Gilead Sciences — NDA Organization

  3. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

  5. Jul 17, 2018

    Johnson and Johnson — Marketing Organization

  6. Jul 17, 2018

    Johnson and Johnson — NDA Secondary Org

2020s

  1. Jul 8, 2021

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  2. Mar 11, 2022

    Laurus Labs Ltd — Marketing Organization

  3. Mar 30, 2022

    Cipla — NDA Secondary Org

  4. Sep 15, 2022

    Shilpa Medicare Ltd. — Marketing Organization

  5. Sep 27, 2022

    Cipla — Marketing Organization

  6. Dec 19, 2022

    Aurobindo Pharma — Marketing Organization

  7. Jan 19, 2023

    Lupin — NDA Secondary Org

  8. Mar 30, 2023

    Lupin — Marketing Organization

  9. May 26, 2023

    Aurobindo Pharma — NDA Secondary Org

  10. Mar 21, 2024

    Apotex — Marketing Organization

  11. Apr 7, 2026

    Macleods Pharmaceuticals, Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFast trackNov 5, 2015

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)Oc1ccccc1
Mol. weight
476.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • alafenamide
  • alafenamide
  • elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
  • emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide
  • emtricitabine / tenofovir alafenamide
  • genvoya
  • genvoya
  • gs 7340
  • gs 7340
  • gs 7340
  • gs 7340
  • gs 7340
  • gs-7340
  • gs-7340
  • gs-7340
  • gs-7340
  • gs-7340
  • gs-734003
  • gs-734003
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide
  • tenofovir alafenamide fumarate
  • tenofovir alafenamide fumarate
  • tenofovir alafenamide fumarate
  • tenofovir alafenamide fumarate
  • tenofovir alafenamide fumarate
  • tenofovir alagenamide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07258251Phase 4Jan 1, 2026Government of Thailand, Mahidol University, The Task Force for Global Health
NCT07295873Phase 1Dec 30, 2025GNI Group
NCT07253220N/ADec 1, 2025Sun Yat-Sen University
NCT07202546Phase 2Nov 28, 2025ViiV Healthcare
NCT07307586Phase 3Sep 1, 2025Zhengzhou University
NCT07055451Phase 1Aug 12, 2025Gilead Sciences
NCT07203118Phase 2/Phase 3 (Phase 3)Jul 1, 2025Xintong Pharmacy Company
NCT07075146Phase 3May 5, 2025Instituto Mexicano del Seguro Social
NCT06947356N/AMay 3, 2025Guangzhou Medical University
NCT06891066Phase 2Apr 14, 2025Merck
NCT07031063Phase 4Apr 1, 2025Instituto Mexicano del Seguro Social
NCT06830668Phase 4Feb 28, 2025Gilead Sciences, Government of China
NCT06589518Phase 2Jan 1, 2025Sungkyunkwan University
NCT06560684Phase 2Oct 29, 2024National Institute of Allergy and Infectious Diseases (NIAID)
NCT06613685Phase 2/Phase 3 (Phase 3)Oct 21, 2024Gilead Sciences
NCT06630286Phase 3Oct 9, 2024Gilead Sciences
NCT06338826Phase 2Oct 1, 2024Assistance Publique - Hôpitaux de Paris, Government of France
NCT06719310Phase 1/Phase 2 (Phase 2)Aug 28, 2024Capital Medical University, Jiangsu Aidea Pharmaceutical Co., Ltd
NCT06337032Phase 4Aug 27, 2024Gilead Sciences
NCT06544733Phase 2/Phase 3 (Phase 3)Aug 20, 2024Gilead Sciences
Showing 20 of 218 trials
Page 1 / 11

Organizations

Research & Development (216)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit602552002
Janssen Pharmaceutica NVFor profit171542017
MerckFor profit11632018
CONRADFor profit7222016
Fundacion SEIMC-GESIDAAcademic/Hospital7712018
National Institute of Allergy and Infectious Diseases (NIAID)Government7432019
Sun Yat-Sen UniversityAcademic/Hospital7722019
ViiV HealthcareFor profit7442018
Jiao Tong UniversityAcademic/Hospital6232019
Emory UniversityAcademic/Hospital5422017
Fudan UniversityAcademic/Hospital5422021
Harvard UniversityAcademic/Hospital5342018
National Taiwan UniversityAcademic/Hospital5432010
Capital Medical UniversityAcademic/Hospital4132020
Eastern Virginia Medical SchoolAcademic/Hospital4322018
United States Agency for International DevelopmentGovernment4022016
University of BarcelonaAcademic/Hospital4332020
University of LondonAcademic/Hospital4342020
Assembly BiosciencesFor profit3312018
Centers for Disease Control and Prevention (CDC)Government3022017
216 organizations
Page 1 / 11

Marketing (17)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGMar 21, 2024
Aurobindo PharmaFor profitMKTGDec 19, 2022
Aurobindo PharmaFor profitNDA2May 26, 2023
CiplaFor profitMKTGSep 27, 2022
CiplaFor profitNDA2Mar 30, 2022
Gilead SciencesFor profitSYNNov 5, 2015
Gilead SciencesFor profitNDANov 5, 2015
Johnson and JohnsonFor profitMKTGJul 17, 2018
Johnson and JohnsonFor profitNDA2Jul 17, 2018
Laurus Labs LtdFor profitMKTGMar 11, 2022
LupinFor profitNDA2Jan 19, 2023
LupinFor profitSYNJul 18, 2023
LupinFor profitMKTGMar 30, 2023
LupinFor profitSYNMar 30, 2023
Macleods Pharmaceuticals, LtdFor profitMKTGApr 7, 2026
Shilpa Medicare Ltd.For profitMKTGSep 15, 2022
Sunshine Lake Pharma Co., Ltd.For profitMKTGJul 8, 2021