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fosamprenavir

Trade name: lexiva

Small moleculeapprovedFast Track FDA

Approved

Oct 20, 2003

Fosamprenavir (FPV), sold under the brand names Lexiva and Telzir, is a medication used to treat HIV/AIDS. It is a prodrug of the protease inhibitor and antiretroviral drug amprenavir. It is marketed by ViiV Healthcare as the calcium salt. — Wikipedia

Clinical trial activity

47 trials · 49 clinical orgs · 5 marketing orgs

Phase 1
10
Phase 2
24
Phase 3
19
Phase 4
9

Earliest trial started Nov 1, 2000 (NCT00008554)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  3. Oct 20, 2003

    GlaxoSmithKline — Earliest FDA Approval

  4. Oct 20, 2003

    GlaxoSmithKline — NDA Organization

  5. Oct 20, 2003

    ViiV Healthcare — NDA Secondary Org

  6. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 15, 2016

    Mylan — Marketing Organization

  2. Jul 25, 2016

    Lupin — Marketing Organization

  3. Nov 20, 2019

    Sun Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackOct 20, 2003

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)CN(C[C@@H](OP(=O)(O)O)[C@H](Cc1ccccc1)NC(=O)O[C@H]1CCOC1)S(=O)(=O)c1ccc(N)cc1
Mol. weight
585.62 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • (3-(((4-aminophenyl)sulfonyl)(2-methylpropyl)amino)-1-(phenylmethyl)-2-(phosphonooxy)propyl)carbamic acid c-(tetrahydro-3-furanyl) ester
  • amprenavir phosphate
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fosamprenavir
  • fos-amprenavir
  • fos-amprenavir
  • fos-amprenavir
  • fos-amprenavir
  • fos-amprenavir
  • fos-amprenavir
  • fosamprenavir calcium
  • fosamprenavir calcium
  • fosamprenavir calcium
  • fosamprenavir calcium
  • fosamprenavir calcium
  • fosamprenavir calcium
  • gw433908
  • gw433908
  • gw433908
  • gw433908
  • gw 433908
  • gw-433908
  • gw-433908
  • gw433908g
  • gw433908g
  • gw433908g
  • gw 433908g
  • gw-433908g
  • gw 908
  • gw-908
  • gw908 cpd
  • lexiva
  • lexiva
  • lexiva
  • lexiva
  • lexiva
  • telzir
  • telzir
  • telzir
  • telzir
  • vx 175
  • vx-175
  • vx175 cpd

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04383262Phase 3Dec 1, 2020Medical College of Wisconsin
NCT02616783Phase 3Dec 22, 2015Gilead Sciences
NCT02605954Phase 3Nov 18, 2015Gilead Sciences
NCT02469246Phase 3Jun 29, 2015Gilead Sciences
NCT02513147Phase 4Jun 1, 2015Ghent University, IrsiCaixa, Universidad Autonoma de Barcelona
NCT01923311Phase 2/Phase 3 (Phase 3)Aug 26, 2013Gilead Sciences
NCT01637259Phase 4Jun 1, 2012Brisbane Sexual Health and HIV Service, Hospital Italiano de Buenos Aires, University of New South Wales
NCT01475838Phase 3Nov 1, 2011Gilead Sciences
NCT01290211Phase 1Apr 1, 2011Pfizer, ViiV Healthcare
NCT01222611Phase 4Mar 1, 2011Fundacion SEIMC-GESIDA, Universidad Autonoma de Madrid, ViiV Healthcare
NCT01252940Phase 3Nov 1, 2010Gilead Sciences
NCT01209065Phase 1Sep 1, 2010GlaxoSmithKline, ViiV Healthcare
NCT01140412Phase 1Jul 1, 2010Pfizer, ViiV Healthcare
NCT01183208Phase 1Dec 1, 2009Bio-Kinetic Clinical Applications, Plethora Solutions Ltd, Shionogi, Theorem Clinical Research
NCT00977301Phase 1Nov 1, 2009GlaxoSmithKline, Radboud University
NCT01010399Phase 4Sep 1, 2009Felizarta, Franco, M.D., Franco Felizarta, MD, GlaxoSmithKline
NCT00817765Phase 1Jan 1, 2009GlaxoSmithKline, Radboud University
NCT00802074N/ADec 1, 2008Garden State Infectious Disease Associates, PA, GlaxoSmithKline, Rowan University
NCT00764465Phase 2Oct 1, 2008Garden State Infectious Disease Associates, PA, GlaxoSmithKline, Rowan University
NCT00727597Phase 3Jul 1, 2008Georgetown University, GlaxoSmithKline
Showing 20 of 47 trials
Page 1 / 3

Organizations

Research & Development (49)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit23652001
ViiV HealthcareFor profit111042001
Gilead SciencesFor profit7712008
Garden State Infectious Disease Associates, PAAcademic/Hospital3322008
Rowan UniversityAcademic/Hospital3022008
Emory UniversityAcademic/Hospital2112005
Glaxo WellcomeFor profit2212000
National Institute of Allergy and Infectious Diseases (NIAID)Government2222001
PfizerFor profit2012010
Radboud UniversityAcademic/Hospital2212009
RocheFor profit2122005
University of North Carolina at Chapel HillAcademic/Hospital2022001
Badalona Hospital Germans Trias i PujolAcademic/Hospital1112005
Bio-Kinetic Clinical ApplicationsFor profit1012009
Brisbane Sexual Health and HIV ServiceAcademic/Hospital1012012
Bristol-Myers SquibbFor profit1012005
Duke UniversityAcademic/Hospital1112006
Felizarta, Franco, M.D.Academic/Hospital1112009
Franco Felizarta, MDAcademic/Hospital1012009
French National Agency for Research on AIDS and Viral HepatitisGovernment1112005
49 organizations
Page 1 / 3

Marketing (6)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDAOct 20, 2003
LupinFor profitMKTGJul 25, 2016
MylanFor profitMKTGApr 15, 2016
MylanFor profitSYNApr 15, 2016
Sun PharmaceuticalsFor profitMKTGNov 20, 2019
ViiV HealthcareFor profitNDA2Oct 20, 2003