DL-Arginine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials are currently evaluating the therapeutic utility of arginine-containing formulations for conditions such as thiazide-associated hyponatremia, chronic obstructive pulmonary disease, and dentine hypersensitivity. Spanning Phase 1 evaluation, observational research, and non-phase diagnostic investigations, these active programs are led by academic and institutional sponsors including University Hospital Basel, Universitätsklinikum Hamburg-Eppendorf, and the Armed Forces Institute of Dentistry Pakistan. The trials are presently recruiting participants or preparing to initiate recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06381934	Not yet recruiting	Thiazide Associated Hyponatremia	University Hospital Basel Switzerland	2024-05	Not Applicable
NCT06265623	Not yet recruiting	Chronic Obstructive Pulmonary Disease (COPD)	Universitätsklinikum Hamburg-Eppendorf	2024-03-01	--
NCT06273930	Recruiting	Sensitivity Tooth	Armed Forces Institute of Dentistry Pakistan	2024-02-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

DL-Arginine functions as a key amino acid substrate within protein synthesis and enzymatic pathways, driving nitric oxide production and cellular metabolic cascades that govern cellular proliferation, tissue repair, and vascular reactivity. These physiological mechanisms directly support its investigation in clinical trial settings, where arginine-based formulations facilitate dentin remineralization in tooth sensitivity and help regulate vascular and metabolic pathways in conditions such as chronic obstructive pulmonary disease and thiazide-associated hyponatremia.

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>).