crotalidae antivenin polyvalent (equine)

Animal productapproved

Approved

Feb 8, 1954

Clinical trial activity

11 trials · 11 clinical orgs · 1 marketing orgs

Phase 1
5
Phase 2
3
Phase 3
2
Phase 4
1

Earliest trial started Jan 1, 2004 (NCT00728715)

Timeline

1950s

  1. Feb 8, 1954

    American Home Products — Earliest FDA Approval

  2. Feb 8, 1954

    American Home Products — NDA Secondary Org

  3. Feb 8, 1954

    American Home Products — NDA Organization

2000s

  1. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedFeb 8, 1954

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • antivenin (crotalidae) polyvalent
  • antivipmyn

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02832765Phase 2Sep 1, 2016University of Heidelberg
NCT04470791N/AJan 1, 2015Hospital Juarez de Mexico
NCT01525511Phase 1Jun 1, 2012Mahidol University, University of Oxford
NCT01416363Phase 1May 1, 2011GlaxoSmithKline
NCT01199627Phase 3Mar 1, 2011Basque Country University, Government of Spain
NCT01218932Phase 1Oct 1, 2010Mahidol University, University of Oxford
NCT01267071Phase 1Jun 14, 2010GlaxoSmithKline
NCT01424462Phase 1Apr 19, 2010GlaxoSmithKline
NCT01026116Phase 3Dec 1, 2009Fudan University
NCT00639951Phase 4Jan 1, 2008Instituto Bioclon
NCT00728715N/AJan 1, 2004Esteve Labs, Hospital General de Requena
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit3312010
Mahidol UniversityAcademic/Hospital2012010
University of OxfordAcademic/Hospital2212010
Basque Country UniversityAcademic/Hospital1012011
Esteve LabsFor profit1012004
Fudan UniversityAcademic/Hospital1112009
Government of SpainGovernment1112011
Hospital General de RequenaAcademic/Hospital1112004
Hospital Juarez de MexicoAcademic/Hospital1112015
Instituto BioclonFor profit1112008
University of HeidelbergAcademic/Hospital1112016
11 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
American Home ProductsFor profitNDA2Feb 8, 1954
American Home ProductsFor profitNDAFeb 8, 1954