Kynurenic acid Clinical Trials

Size	Price	Qty
100mg	USD 97
1g	USD 470

Clinical Trials

Multiple clinical trials investigate kynurenic acid and the tryptophan metabolic pathway across diverse indications, including alcohol use disorder, chronic kidney disease, dementia, pediatric migraine, drug-drug interactions, post-surgical neuroinflammation, and hypertrophic scarring. Spanning Early Phase 1, Phase 1, and unclassified designs, these studies encompass completed, active, pending, and unknown recruitment statuses. Research is sponsored by academic medical centers, research foundations, and pharmaceutical companies such as the University of Maryland Baltimore and VistaGen Therapeutics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06029296	Not yet recruiting	Alcohol Use Disorder	University of Maryland Baltimore	2024-04	Early Phase 1
NCT06314503	Recruiting	Renal Insufficiency Chronic\|Kidney Failure Chronic\|Chronic Kidney Diseases	UMC Utrecht\|European Commission Horizon 2020\|Dutch Kidney Foundation\|Health Holland\|Nanodialysis Ltd\|Università degli studi di Modena e Reggio Emilia (UNIMORE)\|Servicio Madrileno De Salud (SERMAS)\|PPI Healthcare Consulting Ltd	2024-01-22	Not Applicable
NCT05488951	Recruiting	Dementia	Augusta University	2022-07-01	Not Applicable
NCT05969990	Recruiting	Migraine in Children	Qilu Hospital of Shandong University	2022-01-01	--
NCT05280054	Unknown status	Drug Drug Interaction	VistaGen Therapeutics Inc.\|Parexel	2021-12-23	Phase 1
NCT07644065	COMPLETED	Impacted Third Molar; Postoperative Pain; Neuroinflammation; Anxiety	Plovdiv Medical University	2019-09-30
NCT02340325	COMPLETED	Cicatrix; Cicatrix, Hypertrophic; Keloid	British Columbia Professional Firefighters' Burn and Wound Healing Laboratory	2015-05	PHASE1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous tryptophan metabolite, kynurenic acid acts as a broad-spectrum antagonist at N-methyl-D-aspartate, kainate, and AMPA ionotropic glutamate receptors, thereby blocking excitatory glutamatergic signaling and reducing intracellular calcium influx and neurotoxicity. This suppression of excitatory ionotropic receptor activation provides the mechanistic foundation for its therapeutic evaluation in mitigating neuroinflammation, postoperative pain, and central nervous system disorders in clinical trials.

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>).