Clinical Trials

Several clinical trials investigate conditions and biological processes associated with kynurenine pathway signaling and tryptophan metabolites, focusing on therapeutic areas such as delayed graft function, acute kidney injury, adult migraine disorders, and pediatric migraine. The landscape encompasses Phase II, Phase III, and observational designs sponsored by academic medical centers and public research institutions. Recruitment statuses across these protocols include completed, actively recruiting, and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05513807 Not yet recruiting
Delayed Graft Function
Assistance Publique - Hôpitaux de Paris|Institut National de la Santé Et de la Recherche Médicale France|Centre National de la Recherche Scientifique France
2022-11 Phase 3
NCT05718310 Recruiting
Migraine|Migraine Disorders|Pain
IRCCS National Neurological Institute C. Mondino Foundation|University of Pavia
2022-11-01 Not Applicable
NCT05969990 Recruiting
Migraine in Children
Qilu Hospital of Shandong University
2022-01-01 --
NCT04342975 Completed
AKI
Mayo Clinic|Elysium Health
2020-12-01 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quinolinic acid selectively binds and activates N-methyl-D-aspartate (NMDA) receptors, triggering excessive ion channel opening and downstream intracellular calcium influx within vulnerable neuronal populations. This persistent calcium overload leads to cellular excitotoxicity and metabolic dysfunction, providing a pathophysiological mechanism relevant to clinical studies exploring neurovascular and ischemic conditions such as migraine disorders and acute kidney injury.

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>).

Note: Technical data last updated: Sep 1, 2026.