foscarnet

Trade name: foscavir

Small moleculeapproved

Approved

Sep 27, 1991

Foscarnet is an antiviral agent. Foscarnet shows activity against human herpesviruses and HIV. Foscarnet is used for treating eye problems caused by CMV in people with AIDS. It is also used to treat a type of HSV that cannot be treated by another medicine in people with a weak immune system. FOSCAVIR is the brand name for foscarnet sodium. FOSCAVIR is an organic analogue of inorganic pyrophosphate that inhibits replication of herpesviruses in vitro including cytomegalovirus (CMV) and herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). FOSCAVIR exerts its antiviral activity by a selective inhibition at the pyrophosphate binding site on virusspecific DNA polymerases at concentrations that do not affect cellular DNA polymerases. FOSCAVIR does not require activation (phosphorylation) by thymidine kinase or other kinases and therefore is active in vitro against HSV TK deficient mutants and CMV UL97 mutants. Thus, HSV strains resistant to acyclovir or CMV strains resistant to ganciclovir may be sensitive to FOSCAVIR. — NCATS

Clinical trial activity

29 trials · 31 clinical orgs · 8 marketing orgs

Phase 1
7
Phase 2
11
Phase 3
5
Phase 4
4

Earliest trial started Mar 1, 1990 (NCT00000136)

Timeline

1990s

  1. Jan 1, 1990

    Earliest Phase 3 Sponsor(trial)

  2. Sep 27, 1991

    Clinigene International Ltd — Earliest FDA Approval

  3. Sep 27, 1991

    Clinigene International Ltd — NDA Organization

  4. Sep 27, 1991

    Clinigene International Ltd — NDA Secondary Org

  5. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. May 31, 2005

    Hospira — Marketing Organization

2020s

  1. Jan 29, 2021

    Fresenius — Marketing Organization

  2. Apr 21, 2021

    Gland Pharma Ltd — Marketing Organization

  3. Apr 21, 2021

    Fosun — Marketing Organization

  4. Jun 5, 2023

    Avet Lifesciences — Marketing Organization

  5. Nov 29, 2023

    Beijing Pearl Biotechnology Limited Liability Company — Marketing Organization

  6. Mar 1, 2024

    Amneal Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewSep 27, 1991

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)P(=O)(O)O
Mol. weight
126 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • carboxyphosphonic acid
  • carboxyphosphonic acid
  • dihydroxyphosphinecarboxylic acid oxide
  • dihydroxyphosphinecarboxylic acid oxide
  • ehb-776
  • ehb-776
  • foscarmet
  • foscarmet
  • foscarnet
  • foscarnet
  • foscarnet
  • foscarnet
  • foscarnet
  • foscarnet
  • foscarnet
  • foscarnet
  • foscarnet sodium
  • foscarnet sodium
  • foscarnet sodium
  • foscarnet sodium
  • foscarnet sodium hydrate
  • foscavir
  • foscavir
  • foscavir
  • foscavir
  • foscavir
  • foscavir
  • foscavir
  • phosphonocarboxylic acid
  • phosphonoformate
  • phosphonoformate
  • phosphonoformic acid
  • phosphonoformic acid
  • phosphonoformic acid
  • phosphonomethanoic acid
  • phosphonomethanoic acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03073967Phase 2May 8, 2017AiCuris Anti-infective Cures GmbH, Medpace, Inc.
NCT02931539Phase 3Dec 1, 2016Shire
NCT03004261Phase 4Nov 1, 2016Jiao Tong University, Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
NCT02151240Phase 4May 1, 2014Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Peking University
NCT01199562N/ADec 1, 2010City of Hope National Medical Center, National Cancer Institute (NCI)
NCT00986557Phase 2Sep 1, 2009University of Birmingham
NCT00000766Phase 2Nov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000856Phase 1Nov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000964Phase 1Nov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000970Phase 1Nov 2, 1999Astra, National Institute of Allergy and Infectious Diseases (NIAID), Roche
NCT00000985Phase 3Nov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001002Phase 1Nov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001061Phase 2Nov 2, 1999Facet Biotech, National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002039N/ANov 2, 1999Astra
NCT00002125Phase 4Nov 2, 1999Astra
NCT00002144Phase 1Nov 2, 1999Astra
NCT00002145Phase 3Nov 2, 1999Astra
NCT00002146Phase 4Nov 2, 1999Astra
NCT00002272N/ANov 2, 1999Astra
NCT00002301N/ANov 2, 1999Astra
Showing 20 of 29 trials
Page 1 / 2

Organizations

Research & Development (31)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government131241992
AstraFor profit10941999
Johns Hopkins UniversityAcademic/Hospital3221990
Baylor UniversityAcademic/Hospital2011990
Cornell UniversityAcademic/Hospital2011990
Icahn School of Medicine at Mount SinaiAcademic/Hospital2011990
National Eye Institute (NEI)Government2011990
New York Presbyterian HospitalAcademic/Hospital2011990
New York UniversityAcademic/Hospital2011990
Northwestern UniversityAcademic/Hospital2011990
University of California, Los AngelesAcademic/Hospital2011990
University of California, San DiegoAcademic/Hospital2011990
University of California, San FranciscoAcademic/Hospital2011990
University of MiamiAcademic/Hospital2011990
University of WisconsinAcademic/Hospital2011990
AiCuris Anti-infective Cures GmbHFor profit1112017
City of Hope National Medical CenterAcademic/Hospital1112010
Facet BiotechFor profit1011999
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,LtdFor profit1112014
Jiao Tong UniversityAcademic/Hospital1112016
31 organizations
Page 1 / 2

Marketing (9)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGMar 1, 2024
Avet LifesciencesFor profitMKTGJun 5, 2023
Beijing Pearl Biotechnology Limited Liability CompanyGovernmentMKTGNov 29, 2023
Clinigene International LtdFor profitNDASep 27, 1991
Clinigene International LtdFor profitNDA2Sep 27, 1991
FosunFor profitMKTGApr 21, 2021
FreseniusFor profitMKTGJan 29, 2021
Gland Pharma LtdFor profitMKTGApr 21, 2021
HospiraFor profitMKTGMay 31, 2005