L-Valine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials have evaluated L-Valine across metabolic and neurological conditions, including traumatic brain injury, intracerebral hemorrhage, inborn errors of metabolism, and sleep-related metabolic or cognitive changes. Encompassing Phase 2 interventional studies and non-phased observational research, these completed trials were sponsored by academic medical centers and specialized research entities, such as the University of Pennsylvania, Göteborg University, Aga Khan University Hospital Pakistan, and the National Neuroscience Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03711903	COMPLETED	Intracerebral Hemorrhage	National Neuroscience Institute	2019-03-24	PHASE2
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
NCT04949607	Completed	Brain Injury Chronic\|Brain Injuries Traumatic	Centre for Neuro Skills\|University of Texas	2021-07-28	Not Applicable
NCT05437445	Completed	Inborn Errors of Metabolism	Aga Khan University Hospital Pakistan	2019-08-01	--

(data from https://clinicaltrials.gov, updated on 2022-12-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential branched-chain amino acid, L-Valine incorporates into nascent polypeptide chains and serves as an integral substrate for cellular protein synthesis and metabolic energy pathways. By supporting tissue repair and maintaining nitrogen homeostasis, L-Valine promotes cellular restoration and metabolic stability, which underlies its therapeutic relevance in clinical investigations of inborn errors of metabolism, traumatic brain injury, and metabolic disturbances.

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>).