CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

edetic acid

Small moleculeapproved

Approved

Jul 16, 1953

Edetic acid (EDTA) is a chelating agent. The U.S. Food and Drug Administration (FDA) approved edetic acid chelation therapy as a treatment for lead and heavy metal poisoning. Edetic acid in form of disodium salt was withdrawn from the market due to death resulting from hypocalcemia during chelation. — NCATS

Clinical trial activity

24 trials · 28 clinical orgs · 3 marketing orgs

Phase 1
5
Phase 2
11
Phase 3
6
Phase 4
4

Earliest trial started Nov 1, 2001 (NCT00227409)

Timeline

1950s

  1. Jul 16, 1953

    Bausch Health Companies — Earliest FDA Approval

  2. Jul 16, 1953

    Medicis — NDA Secondary Org

  3. Jul 16, 1953

    Bausch Health Companies — Marketing Organization

  4. Jul 16, 1953

    Bausch Health Companies — NDA Secondary Org

  5. Jul 16, 1953

    Bausch Health Companies — NDA Organization

2000s

  1. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 2 Sponsor(trial)

2020s

  1. May 3, 2023

    Casper Pharma LLC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • CalciumCHELATING AGENT

    Calcium chelating agent

    Divalent and Trivalent metal chelating agent. Removes Ca2+ in case of hypercalciemia

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedPriority reviewJul 16, 1953

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)CN(CCN(CC(O)=O)CC(O)=O)CC(O)=O
Mol. weight
292.2426 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
  • 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
  • acide edetique
  • acide edetique
  • acide ethylenediaminetetracetique
  • acide ethylenediaminetetracetique
  • acido edetico
  • acido edetico
  • acidum edeticum
  • acidum edeticum
  • {[-(bis-carboxymethyl-amino)-ethyl]-carboxymethyl-amino}-acetic acid
  • {[-(bis-carboxymethyl-amino)-ethyl]-carboxymethyl-amino}-acetic acid
  • calcium disodium edetate
  • calcium disodium edetate
  • calcium disodium edta
  • calcium disodium edta
  • calcium disodium edta
  • calcium disodium versenate
  • calcium disodium versenate
  • calcium disodium versenate
  • calcium edetate sodium
  • calciumedetate sodium
  • calciumedetate sodium
  • calcium edta
  • calcium edta
  • calcium edta
  • calcium edta complex
  • calcium tetracemine disodium
  • calcium tetracemine disodium
  • disodium edetate
  • disodium edetate
  • disodium edta
  • disodium edta
  • e385
  • e385
  • e386
  • e386
  • edathamil
  • edathamil
  • edathamil
  • edetate
  • edetate
  • edetate calcium disodium
  • edetate calcium disodium
  • edetate calcium disodium
  • edetate calcium disodium
  • edetate calcium disodium
  • edetate calcium disodium
  • edetate disodium
  • edetate disodium
  • edetate disodium
  • edetate disodium
  • edetate disodium
  • edetate disodium
  • edetic acid
  • edetic acid
  • edetic acid
  • edetic acid
  • edetic acid
  • edetic acid
  • edta
  • edta
  • edta
  • edta
  • edta
  • edta calcium
  • edta calcium
  • edta calcium disodium
  • edta calcium disodium
  • edta disodium
  • edta disodium salt
  • edta, ion(4-)
  • edta, ion(4-)
  • edthamil
  • endrate
  • endrate
  • endrate
  • ethylenediaminetetraacetate
  • ethylenediaminetetraacetate
  • ethylenediaminetetraacetate
  • ethylenediaminetetraacetic acid
  • ethylenediaminetetraacetic acid
  • ethylenediaminetetraacetic acid
  • ethylenedinitrilotetraacetate disodium
  • ethylenedinitrilotetraacetate disodium
  • ethylenedinitrilotetraacetic acid
  • (ethylenedinitrilo)tetraacetic acid, ion(4−)
  • (ethylenedinitrilo)tetraacetic acid, ion(4−)
  • ledclair
  • ledclair
  • n,n'-1,2-ethane diylbis-(n-(carboxymethyl)glycine)
  • n,n'-1,2-ethane diylbis-(n-(carboxymethyl)glycine)
  • sodium calciumedetate
  • sodium calciumedetate
  • sodium calcium edetate
  • sodium calcium edetate
  • sodium edetate
  • sodium edetate
  • sodium edetate
  • sodium versenate
  • sodium versenate
  • unii-25ih6r4sgf
  • unii-pkv6bfv915
  • versenate
  • versenate
  • versene acid
  • versene acid
  • versene ca
  • versene ca

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07191262N/ADec 31, 2025University of Alabama, Birmingham
NCT04893577Phase 2Nov 30, 2021University of Utah
NCT03982693Phase 3Mar 19, 2019Mt. Sinai Medical Center, Miami
NCT03630991Phase 2Oct 31, 2018University of Texas at Houston
NCT02421029Phase 4Jul 1, 2017Mt. Sinai Medical Center, Miami
NCT03853200Phase 2/Phase 3 (Phase 3)Apr 3, 2017Dow University of Health Sciences
NCT02733185Phase 3Oct 1, 2016Duke University, Icahn School of Medicine at Mount Sinai, Mt. Sinai Medical Center, Miami, National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI)
NCT03419429Phase 4Jan 31, 2016Ain Shams University
NCT03424746Early Phase 1 (Phase 1)Aug 31, 2015Icahn School of Medicine at Mount Sinai, Mt. Sinai Medical Center, Miami
NCT02300376Phase 3Dec 1, 2014University of Limoges
NCT02286258Phase 1/Phase 2 (Phase 2)Oct 1, 2014Government of France, University of Paris
NCT02127190Phase 1Apr 1, 2014Complexa, Inc., Jasper Clinic, Inc.
NCT02618317Phase 4Jul 1, 2013Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo
NCT01539343Phase 2Apr 1, 2013Triax, University of Texas at Houston
NCT03336970N/AJan 1, 2011Ege University
NCT01118663Phase 3Sep 1, 2010Cumberland Pharmaceuticals
NCT01101412Phase 1/Phase 2 (Phase 2)Apr 9, 2010National Cancer Institute (NCI), University of Texas at Houston
NCT00757458N/ADec 1, 2008AstraZeneca, University of Sao Paulo
NCT01030666Phase 4Apr 1, 2007Dr. August Wolff GmbH & Co. KG Arzneimittel, Gaba International AG, J. W. Goethe University, University of Heidelberg
NCT00378781N/ASep 19, 2006National Cancer Institute (NCI), University of Texas at Houston
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (28)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mt. Sinai Medical Center, MiamiAcademic/Hospital5532003
University of Texas at HoustonAcademic/Hospital4422006
Icahn School of Medicine at Mount SinaiAcademic/Hospital3022003
Chang Gung UniversityAcademic/Hospital2212001
National Cancer Institute (NCI)Government2022006
National Center for Complementary and Integrative Health (NCCIH)Government2012003
National Heart, Lung, and Blood Institute (NHLBI)Government2012003
University of Sao PauloAcademic/Hospital2222008
Ain Shams UniversityAcademic/Hospital1112016
AstraZenecaFor profit1012008
Complexa, Inc.For profit1112014
Cumberland PharmaceuticalsFor profit1112010
Dow University of Health SciencesAcademic/Hospital1112017
Dr. August Wolff GmbH & Co. KG ArzneimittelFor profit1012007
Duke UniversityAcademic/Hospital1012016
Ege UniversityAcademic/Hospital1112011
Fundação de Amparo à Pesquisa do Estado de São PauloAcademic/Hospital1012013
Gaba International AGFor profit1012007
Government of FranceGovernment1012014
Jasper Clinic, Inc.For profit1012014
28 organizations
Page 1 / 2

Marketing (5)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitMKTGJul 16, 1953
Bausch Health CompaniesFor profitNDA2Jul 16, 1953
Bausch Health CompaniesFor profitNDAJul 16, 1953
Casper Pharma LLCFor profitMKTGMay 3, 2023
MedicisFor profitNDA2Jul 16, 1953