Clinical Trials

Multiple clinical trials evaluate conditions including Werner Syndrome, ankle fractures, acute myeloid leukemia, and vasculopathy. Sponsored by organizations such as PRG Science & Technology Co. Ltd., the University of Calgary, Aptevo Therapeutics, and Montefiore Medical Center, these investigations span Phase 1, combined Phase 1/Phase 2, Phase 2, and trials designated as not applicable. Their recruitment statuses indicate that the studies are currently either not yet recruiting or have been withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05847179 Not yet recruiting
Werner Syndrome
PRG Science & Technology Co. Ltd.
 2025-01-01 Phase 2
NCT06303284 Not yet recruiting
Ankle Fractures
University of Calgary
 2025-01-01 Phase 1|Phase 2
NCT04973618 Withdrawn
AML
Aptevo Therapeutics
 2025-01 Phase 1
NCT05251129 Not yet recruiting
Vasculopathy
Montefiore Medical Center
 2025-01 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Following enzymatic bioactivation, N-nitrosodiethylamine generates reactive alkylating intermediates that bind to nucleic acids, causing damaging DNA adducts and disrupting normal genomic integrity. This persistent DNA damage drives mutagenesis and cell transformation, providing a pathway to investigate oncogenic mechanisms in conditions such as acute myeloid leukemia and lung carcinoma.

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.