Clinical Trials

A clinical trial sponsored by an academic institution, the University of California, Los Angeles, evaluated the bioactivity, safety, tolerability, and pharmacokinetic bioavailability of (-)-arctigenin. This completed early-phase, single-arm, dose-escalation study enrolled healthy male participants to establish baseline safety parameters and exposure profiles. The study provides foundational human data to inform potential future clinical evaluation in specific disease indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03703388 COMPLETED
Healthy
University of California, Los Angeles
 2019-01-15

(data from https://clinicaltrials.gov, updated on 2020-08-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

(-)-Arctigenin targets key intracellular signaling enzymes, including MEK and Akt, thereby inhibiting downstream phosphorylation events and blocking NF-kB-mediated transcriptional activation of inflammatory genes. This molecular cascade suppression reduces cellular proliferation and suppresses pro-inflammatory cytokine production, supporting its underlying anti-inflammatory and anticancer activities currently being translated into clinical trial evaluations of human safety and bioavailability.

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.