anidulafungin

Trade name: eraxis

Small moleculeapproved

Approved

Feb 17, 2006

Anidulafungin (brand names Eraxis (in U.S. and Russia) and Ecalta (in Europe)) is a semi-synthetic echinocandin with antifungal activity and it is active in vitro against many Candida, as well as some Aspergillus. Like other echinocandins, anidulafungin is not active against Cryptococcus neoformans, Trichosporon, Fusarium, or zygomycetes. This drug is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis; and for the treatment of esophageal candidiasis. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall. — NCATS

Clinical trial activity

31 trials · 20 clinical orgs · 2 marketing orgs

Phase 1
3
Phase 2
19
Phase 3
12
Phase 4
9

Earliest trial started Aug 1, 2001 (NCT00037219)

Timeline

2000s

  1. Jan 1, 2001

    Pfizer — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Pfizer — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2003

    Pfizer — Earliest Phase 3 Sponsor(trial)

  4. Feb 17, 2006

    Pfizer — Earliest FDA Approval

  5. Feb 17, 2006

    Vicuron Pharmaceuticals — Marketing Organization

  6. Feb 17, 2006

    Vicuron Pharmaceuticals — NDA Secondary Org

  7. Feb 17, 2006

    Pfizer — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedFeb 17, 2006

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCOC1=CC=C(C=C1)C2=CC=C(C=C2)C3=CC=C(C=C3)C(=O)N[C@H]4C[C@@H](O)[C@@H](O)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H]6C[C@@H](O)CN6C(=O)[C@@H](NC4=O)[C@@H](C)O)[C@H](O)[C@@H](O)C7=CC=C(O)C=C7)[C@@H](C)O
Mol. weight
1140.2369 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (4r,5r)-4,5-dihydroxy-n²-[[4''-(pentyloxy)-p-terphenyl-4-yl]carbonyl]-l-ornithyl-l-threonyl-trans-4-hydroxy-l-prolyl-(s)-4-hydroxy-4(p-hydroxyphenyl)-l-threonyl-l-threonyl-(3s,4s)-3-hydroxy-4-methyl-l-proline cyclic (6->1)-peptide
  • (4r,5r)-4,5-dihydroxy-n²-[[4''-(pentyloxy)-p-terphenyl-4-yl]carbonyl]-l-ornithyl-l-threonyl-trans-4-hydroxy-l-prolyl-(s)-4-hydroxy-4(p-hydroxyphenyl)-l-threonyl-l-threonyl-(3s,4s)-3-hydroxy-4-methyl-l-proline cyclic (6->1)-peptide
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungin
  • anidulafungina
  • anidulafungina
  • anidulafungine
  • anidulafungine
  • anidulafunginum
  • anidulafunginum
  • ecalta
  • ecalta
  • ecalta
  • eraxis
  • eraxis
  • eraxis
  • eraxis
  • eraxis
  • ly303366
  • ly 303366
  • ly 303366
  • ly-303366
  • ly-303366
  • n-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-6-[(1s,2r)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.09,13]heptacosan-18-yl]- 4-{4-[4-(pentyloxy)phenyl]phenyl}benzamide
  • n-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-6-[(1s,2r)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.09,13]heptacosan-18-yl]- 4-{4-[4-(pentyloxy)phenyl]phenyl}benzamide
  • v-echinocandin
  • v-echinocandin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04876716Phase 3May 11, 2021Erasmus University Rotterdam, HOVON - Dutch Haemato-Oncology Association, ZonMw: The Netherlands Organisation for Health Research and Development
NCT02021123Phase 4Aug 1, 2014Radboud University
NCT01734525Phase 4Nov 1, 2012Federal University of Rio de Janeiro
NCT01188759Phase 3May 1, 2012Pfizer
NCT01303549Phase 4Nov 1, 2011Fundacion SEIMC-GESIDA, Pfizer, University of Barcelona
NCT01307930Phase 4Jan 1, 2011National Center for Research Resources (NCRR), Texas Tech University, The University of Texas, Dallas
NCT01176058Phase 3Dec 1, 2010Pfizer
NCT01249820Phase 2Nov 1, 2010Radboud University
NCT00934934Phase 2Apr 1, 2010Clinical Evaluation Research Unit at Kingston General Hospital, Pfizer, Queen's University, Belfast, The Physicians' Services Incorporated Foundation
NCT00841971Phase 4Feb 1, 2010University of Pittsburgh
NCT01053884Phase 2Oct 1, 2009KH Elisabethinen Linz, Pfizer
NCT00806351Phase 3Aug 1, 2009Pfizer
NCT00892359Phase 2Apr 1, 2009University of Vienna
NCT00805740Phase 3Apr 1, 2009Pfizer
NCT00761267Phase 3Feb 27, 2009Pfizer
NCT00940017Phase 4Sep 1, 2008Pfizer
NCT00620074Phase 4Aug 1, 2008Pfizer
NCT00531479Phase 3Jul 1, 2008Pfizer
NCT00689338Phase 3Jul 1, 2008Pfizer
NCT00672841N/AJun 1, 2008Duke University, Pfizer
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (20)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit211742001
Vicuron PharmaceuticalsFor profit5022001
Duke UniversityAcademic/Hospital2222008
National Cancer Institute (NCI)Government2222003
Radboud UniversityAcademic/Hospital2222010
Clinical Evaluation Research Unit at Kingston General HospitalAcademic/Hospital1112010
Erasmus University RotterdamAcademic/Hospital1112021
Federal University of Rio de JaneiroAcademic/Hospital1112012
Fundacion SEIMC-GESIDAAcademic/Hospital1112011
HOVON - Dutch Haemato-Oncology AssociationAcademic/Hospital1012021
KH Elisabethinen LinzAcademic/Hospital1112009
National Center for Research Resources (NCRR)Government1012011
Queen's University, BelfastAcademic/Hospital1012010
Texas Tech UniversityAcademic/Hospital1112011
The Physicians' Services Incorporated FoundationAcademic/Hospital1012010
The University of Texas, DallasAcademic/Hospital1012011
University of BarcelonaAcademic/Hospital1012011
University of PittsburghAcademic/Hospital1112010
University of ViennaAcademic/Hospital1112009
ZonMw: The Netherlands Organisation for Health Research and DevelopmentAcademic/Hospital1012021
20 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
PfizerFor profitNDAFeb 17, 2006
Vicuron PharmaceuticalsFor profitMKTGFeb 17, 2006
Vicuron PharmaceuticalsFor profitNDA2Feb 17, 2006
Vicuron PharmaceuticalsFor profitSYNFeb 17, 2006