Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate ethylenediaminetetraacetic acid across therapeutic areas including chronic Pseudomonas aeruginosa lung infections in cystic fibrosis, systemic lupus erythematosus with lupus nephritis, oral herpes simplex, endodontic root canal infections, and myelodysplastic syndromes. Sponsored by commercial entities like Respirion Pharmaceuticals and Becton Dickinson alongside academic institutions such as the University of Utah and Hospices Civils de Lyon, these studies encompass actively recruiting, completed, enrolled by invitation, and not yet recruiting statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07631364 NOT_YET_RECRUITING
Neisseria Gonorrhoeae (Ng) Infections
Assistance Publique - Hôpitaux de Paris
 2026-09 PHASE3
NCT07191262 RECRUITING
Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth
University of Alabama at Birmingham
 2026-03-02
NCT05879835 RECRUITING
Pediatric Intestinal Failure
SterileCare Inc.
 2024-06-21
NCT06386991 UNKNOWN
Endodontic Disease
TC Erciyes University
 2024-01-01 PHASE4
NCT05878249 UNKNOWN
Reversible Pulpitis
Postgraduate Institute of Dental Sciences Rohtak
 2022-11-01
NCT06016088 Recruiting
Cystic Fibrosis Lung|Respiratory Infections Recurrent Chronic|Pseudomonas Aeruginosa
Respirion Pharmaceuticals Pty Ltd
 2024-04-01 Phase 1|Phase 2
NCT06153095 Recruiting
Systemic Lupus Erythematosus|Lupus Nephritis
ImmPACT Bio
 2024-02-15 Phase 1|Phase 2
NCT05778227 COMPLETED
Root Canal Infection; Periapical Abscess; Irreversible Pulpitis; Apical Periodontitis
Dow University of Health Sciences
 2021-11-16
NCT05186311 Completed
Healthy|Disease Chronic|Acute Disease|Sample Collection
Becton Dickinson and Company|Babson Diagnostics Inc.
 2022-04-22 --
NCT04893577 Enrolling by invitation
Herpes Simplex Oral
University of Utah
 2022-01-20 Phase 2
NCT05038059 COMPLETED
Irreversible Pulpitis; Apical Periodontitis; Root Canal Infection
Dow University of Health Sciences
 2020-04-02
NCT02455115 COMPLETED
Acute Kidney Injury; Liver Failure
Sahlgrenska University Hospital
 2015-01
NCT01118663 TERMINATED
Acetaminophen Overdose
Cumberland Pharmaceuticals
 2010-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-22)

Check the Ethylenediaminetetraacetic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ethylenediaminetetraacetic acid acts as a polydentate chelating agent that binds divalent and trivalent metal cations with high affinity, thereby sequestering essential cofactors required for metalloprotease activity and bacterial biofilm matrix stability. By disrupting metal-dependent microbial enzymes and structural pathways, this chelation destabilizes bacterial membranes and inhibits pathogenic growth, providing therapeutic relevance in treating chronic respiratory and mucosal infections investigated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.