Clinical Trials

Multiple clinical trials, spanning Phase 1 and phase-unclassified designations, are evaluating interventions related to metabolic health, nutritional availability, and organ transplantation. These studies address diverse conditions, including Pyruvate Dehydrogenase Complex Deficiency, protein availability in aging populations, gestational diabetes with insulin resistance, and kidney transplant outcomes. Sponsored by a mixture of academic institutions and pharmaceutical entities, their recruitment statuses currently range from not yet recruiting and actively recruiting to suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06340685 Recruiting
Pyruvate Dehydrogenase Complex Deficiency
Jirair Krikor Bedoyan|Ultragenyx Pharmaceutical Inc|University of Pittsburgh
 2024-05 Phase 1
NCT06332651 Recruiting
Ageing
Wageningen University
 2024-02-19 Not Applicable
NCT05305352 Suspended
Gestational Diabetes|Inflammation|Metabolic Syndrome|Glucose Intolerance During Pregnancy|Glucose Intolerance|Insulin Resistance
Khyber Medical University Peshawar
 2024-01 Not Applicable
NCT06160830 Not yet recruiting
Transplanted Kidney
National Nutrition and Food Technology Institute
 2023-12-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-lysine is an essential alpha-amino acid that incorporates into nascent polypeptide chains during ribosomal translation, serving as a critical building block for structural proteins and enzymes required for cellular growth and tissue repair. In clinical contexts such as metabolic disorders like pyruvate dehydrogenase complex deficiency and age-related protein loss, adequate availability of this amino acid supports overall protein synthesis and cellular homeostasis to preserve tissue integrity.

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.