Clinical Trials

Several clinical trials evaluating 2-ketoglutaric acid have achieved completed recruitment status, encompassing Phase 3 research alongside studies with non-applicable phase classifications. These evaluations investigated conditions including metabolic and cognitive alterations resulting from sleep disturbance, myocardial preservation during coronary artery bypass surgery, and urinary excretion alterations in acid-base disorders. Leading academic and medical sponsors include Göteborg University, the University of Pennsylvania, the University of Manitoba, National Cardiovascular Center Harapan Kita Hospital, and Centre Hospitalier Universitaire Vaudois.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05319262 Completed
Noise Exposure|Sleep Disturbance|Sleep Hygiene|Metabolic Disturbance|Cognitive Change
Göteborg University|University of Pennsylvania|University of Manitoba
 2022-04-24 Not Applicable
NCT04560309 Completed
Coronary Artery Bypass|Cardiopulmonary Bypass|Coronary Artery Disease
National Cardiovascular Center Harapan Kita Hospital Indonesia
 2021-01-01 Phase 3
NCT01880281 Completed
Acid Base Disorder
Michel Burnier|Centre Hospitalier Universitaire Vaudois
 2013-06 Not Applicable

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

Check the 2-Ketoglutaric acid (alpha-ketoglutarate) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Ketoglutaric acid functions as a reversible inhibitor of tyrosinase and acts as a pivotal intermediate in the tricarboxylic acid cycle, undergoing oxidative decarboxylation to succinyl-CoA via alpha-ketoglutarate dehydrogenase. By regulating mitochondrial bioenergetics and cellular metabolic rate, the compound supports vital aerobic energy production and metabolic homeostasis, providing a cellular basis for its clinical relevance in addressing metabolic disturbances, protecting myocardium during cardiac surgery, and managing acid-base balance.

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.