Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 have evaluated L-NAME HCl across conditions including orthostatic hypotension, spinal cord injury, microvascular dysfunction, aging, and pulmonary resistance in tetraplegia. Sponsored by academic institutions—such as the University of Delaware and the Medical College of Wisconsin—and government entities like the US Department of Veterans Affairs, these active, recruiting, and completed studies investigate interventions ranging from post-trauma blood pressure management to nitric oxide pathway modulation in vascular and airway reactivity.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06860724 RECRUITING
Major Depressive Disorder
University of Delaware
2025-01-06
NCT06424756 RECRUITING
Healthy
University of Georgia
2024-07-01 PHASE2
NCT06633198 ACTIVE_NOT_RECRUITING
Aging
William Hughes
2025-05-01 EARLY_PHASE1
NCT06159608 RECRUITING
E-cigarette Use
Anna Stanhewicz, PhD
2023-12-02 EARLY_PHASE1
NCT03684213 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction
The University of Texas at Arlington
2018-10-15 PHASE1
NCT00835224 COMPLETED
Orthostatic Hypotension; Spinal Cord Injury
US Department of Veterans Affairs
2010-05 PHASE2
NCT01002482 COMPLETED
Hyperglycemia; Critical Illness
Centre Hospitalier of Chartres
2009-10 PHASE3
NCT00753948 COMPLETED
Tetraplegia; Asthma
VA Office of Research and Development
2006-12 PHASE2; PHASE3
NCT00237770 COMPLETED
Hypotension; Spinal Cord Injury
US Department of Veterans Affairs
2003-06 PHASE2; PHASE3
NCT00603720 COMPLETED
Cardiovascular Diseases
Washington University School of Medicine
2005-09

(data from https://clinicaltrials.gov, updated on 2025-09-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-NAME HCl binds nonselectively to nitric oxide synthase isoforms—including neuronal, endothelial, and inducible variants—thereby blocking the oxidation of L-arginine to nitric oxide and suppressing downstream cyclic GMP signaling. This reduction in endothelial nitric oxide synthesis promotes vascular smooth muscle contraction and restricts vasodilation, providing a mechanistic basis for assessing vascular reactivity, blood pressure elevation, and microvascular function in conditions such as orthostatic hypotension and cardiovascular risk.

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>).

Note: Technical data last updated: Sep 1, 2026.