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)
Mechanism and Biochemical Profile
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>).