4-HNE (4-Hydroxynonenal) Clinical Trials

Size	Price	Qty
5mg	USD 149
25mg	USD 447

Clinical Trials

Several clinical trials evaluate biological effects and oxidative stress markers related to 4-hydroxynonenal pathways across conditions such as amyotrophic lateral sclerosis, frontotemporal dementia, healthy aging, and postoperative pain. Sponsored by academic research centers and foundations, these Phase 2, Phase 2/3, and non-phased protocols range in recruitment status from active not recruiting and not yet recruiting to completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06126315	Not yet recruiting	Amyotrophic Lateral Sclerosis	Mario Negri Institute for Pharmacological Research\|University of Sydney\|FightMND	2024-06	Phase 2\|Phase 3
NCT06724432	COMPLETED	Postoperative Pain; Oxidative Stress Response	University of Parma	2021-06-01
NCT05742698	Active not recruiting	Frontotemporal Dementia\|Frontotemporal Dementia Behavioral Variant\|Primary Progressive Aphasia\|bvFTD\|PPA\|FTD	Simon Ducharme MD\|Alzheimer''s Drug Discovery Foundation\|Douglas Mental Health University Institute	2023-03-07	Phase 2
NCT05829382	Active not recruiting	Healthy Aging	Helse Stavanger HF	2023-03-15	Not Applicable

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

Check the 4-HNE (4-Hydroxynonenal) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a major lipid peroxidation product, 4-hydroxynonenal covalently binds to nucleophilic amino acid residues on functional proteins, inhibiting cellular enzymatic activities and disrupting downstream redox homeostasis. This persistent protein modification and oxidative impairment trigger apoptotic cell death, underlying the tissue damage and pathological progression observed in clinical conditions such as amyotrophic lateral sclerosis, frontotemporal dementia, and postoperative oxidative stress.

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>).