Clinical Trials

A Phase 3 clinical trial is currently evaluating 4-Octyl Itaconate to assess its clinical efficacy and pharmacological mechanisms in patients with atopic dermatitis. Sponsored by a consortium of academic and clinical research institutions, including Chang Gung Memorial Hospital, National Yang Ming University, Taipei Veterans General Hospital, and Taipei Medical University, the study is presently categorized as not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05455060 Not yet recruiting
Atopic Dermatitis
Chang Gung Memorial Hospital|National Yang Ming University|Taipei Veterans General Hospital Taiwan|Taipei Medical University
 2022-12-15 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

4-Octyl Itaconate activates the Nrf2 signaling pathway to suppress the expression and production of pro-inflammatory cytokines in human macrophages and patient-derived peripheral blood mononuclear cells. By dampening hyperactive inflammatory signaling and immune cell activation, this compound exhibits significant potential to alleviate pathological skin inflammation associated with atopic dermatitis.

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.