Edetate Calcium Disodium: trials, targets and approvals

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	CALCIUM DISODIUM VERSENATE	—	1953-07-16	fda.gov ↗

Trials 9

today

US approved 1953

NCT07706946 · not/applicable NCT03630991 · Ph 1 NCT03424746 · Ph 0 NCT03477422 · Ph 3 NCT00926406 · not/applicable NCT00237952 · not/applicable NCT00227409 · not/applicable

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03424746	Aug 2015 → Jan 2019	limb ischemia, peripheral arterial disease	Mt. Sinai Medical Center, Miami	Completed	No outcome recorded
Phase 11 trial
Phase 1	NCT03630991	Oct 2018 → Apr 2027 expected	acute myeloid leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm	M.D. Anderson Cancer Center	Recruiting	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT01101412	—	cancer of unknown primary site, infectious disease, leukemia, lymphoproliferative syndrome +3	M.D. Anderson Cancer Center	Withdrawn	No outcome recorded
Phase 31 trial · 1 met primary
Phase 3	NCT03477422	Jan 2014 → May 2017	acute pyelonephritis	Venus Remedies Limited	Completed	Met primary
Phase not applicable5 trials
—	NCT07706946	Aug 2026 → Jan 2029 expected	diabetic kidney disease	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Not yet recruiting	No outcome recorded
—	NCT00926406	Apr 2010 → Oct 2011	anemia, lead poisoning, protein-energy malnutrition	Chang Gung Memorial Hospital	Unknown	No outcome recorded
—	NCT00237952	Aug 2005 → ?	diabetic kidney disease, type 2 diabetes mellitus	Chang Gung Memorial Hospital	Completed	No outcome recorded
—	NCT00227409	Nov 2001 → Oct 2005	urinary system disorder	Chang Gung Memorial Hospital	Completed	No outcome recorded
—	NCT00378781	—	cancer	M.D. Anderson Cancer Center	Withdrawn	No outcome recorded
Comparator or background therapy4 trials
Phase 3	NCT03982693 Comparator	Mar 2019 → Dec 2026 expected	diabetes mellitus, limb ischemia	Mt. Sinai Medical Center, Miami	Active not recruiting	No outcome recorded
Phase 3	NCT02733185 Comparator	Oct 2016 → Jun 2023	diabetes mellitus, myocardial infarction	Mt. Sinai Medical Center, Miami	Completed	No outcome recorded
Phase 3	NCT00044213 Comparator	Sep 2003 → Oct 2011	coronary artery disorder	Mt. Sinai Medical Center, Miami	Completed	No outcome recorded
Phase 4	NCT02421029 Background	Jul 2017 → Dec 2018	heavy metal poisoning	Mt. Sinai Medical Center, Miami	Withdrawn	No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

Field	Value	Cited text
Known as	edetate calcium disodium	“Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA) flush solution into the CVC once daily.” NCT00378781 ↗ 4 “calcium disodium EDTA (edetate calcium disodium)” NCT00227409 ↗ NCT01101412 ↗ NCT03630991 ↗ NCT02421029 ↗
Known as	Calcium Disodium Edetate	“Calcium Disodium Edetate Injection” NCT07706946 ↗
Known as	calcium disodium EDTA	“the 25 patients in the study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the body lead burden fallsl below 50 μg” NCT00237952 ↗ 2 “one vial (1 g) of calcium di-sodium EDTA mixed with 200 ml of normal saline” NCT00926406 ↗ NCT00227409 ↗
Known as	disodium EDTA	“BACKGROUND: CSE is a novel combination of ceftriaxone, sulbactam and disodium EDTA with activity against multidrug resistant gram-negative pathogens.” PMID 31433059 ↗ Oct 2019 3 “with disodium EDTA, compared with placebo” PMID 23532240 ↗ Mar 2013 “Drug: disodium EDTA” NCT03424746 ↗ NCT02733185 ↗
Known as	Edetate Disodium	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03982693 ↗
Known as	EDTA	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03477422 ↗ 2 NCT00044213 ↗ NCT03424746 ↗
Known as	ethylene diamine tetra-acetic	“ethylene diamine tetra-acetic (EDTA) chelation therapy” NCT00044213 ↗
Modality	Small molecule	“a synthetic amino acid” NCT00044213 ↗
Route	Intravenous	“intravenous chelation regimen” PMID 23532240 ↗ Mar 2013