Clinical Trials

A clinical trial sponsored by the Danish Headache Center evaluated the experimental compound L-kynurenine for its potential role in headache disorders. This completed Phase I study assessed the physiological effects of intravenous L-kynurenine administration on cerebral hemodynamics in healthy volunteers. Findings from this investigation provide valuable insights into how L-kynurenine modulates central nervous system vascular responses to further elucidate vascular headache pathophysiology.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03212430 COMPLETED
Headache
Danish Headache Center
 2017-03-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2019-01-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Kynurenine acts as an endogenous agonist of the aryl hydrocarbon receptor (AhR), driving receptor nuclear translocation and downstream transcriptional regulation of metabolic and immune signaling pathways. This molecular cascade influences vascular tone and neurogenic signaling, establishing a functional rationale for its clinical evaluation regarding cerebral hemodynamics and headache pathophysiology.

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.