Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 have evaluated L-NMMA acetate across various cardiovascular, metabolic, and respiratory conditions, including hyperlipidemias, hypertension, obesity, pulmonary diseases, and heart failure. Displaying statuses ranging from completed and recruiting to terminated or withdrawn, these studies examine specific physiological processes such as GLP-2 mediated lipoprotein release and vascular blood flow dynamics. Research efforts are broadly supported by diverse entities, including academic institutions, pharmaceutical companies, and government organizations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05660083 RECRUITING
HER2-negative Breast Cancer; Metastatic Breast Cancer; Metaplastic Breast Carcinoma; TNBC - Triple-Negative Breast Cancer
The Methodist Hospital Research Institute
 2023-01-12 PHASE2
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT01791816 COMPLETED
Vasovagal Syncope; Postural Tachycardia Syndrome
New York Medical College
 2013-02 EARLY_PHASE1
NCT03066115 WITHDRAWN
Hypoxia; Hypercapnia
University of Wisconsin, Madison
 2020-12-01 PHASE1
NCT03236935 COMPLETED
Non-Small Cell Lung Cancer; Malignant Melanoma; Head and Neck Squamous Cell Carcinoma; Classical Hodgkin Lymphoma; Urothelial Carcinoma Bladder; DNA Repair-Deficiency Disorders
The Methodist Hospital Research Institute
 2018-08-27 PHASE1
NCT02834403 COMPLETED
Metastatic Triple Negative Breast Cancer
The Methodist Hospital Research Institute
 2016-11 PHASE1; PHASE2
NCT03446612 TERMINATED
Anaemia
GlaxoSmithKline
 2019-01-10 PHASE2
NCT03534661 COMPLETED
Hyperlipidemias
University Health Network, Toronto
 2017-09-27 PHASE2; PHASE3
NCT01701973 COMPLETED
Obesity
Vanderbilt University
 2013-01 PHASE4
NCT00580619 COMPLETED
Chronic Fatigue Syndrome; Orthostatic Intolerance; Postural Tachycardia Syndrome
Vanderbilt University
 2007-04 PHASE1
NCT01122407 COMPLETED
Obesity; Hypertension
Vanderbilt University Medical Center
 2010-01 PHASE1
NCT02183779 UNKNOWN
Raynaud Disease; Hyperemia; Cold
University Hospital, Grenoble
 2014-06
NCT01744236 COMPLETED
Type 2 Diabetes
Amsterdam UMC, location VUmc
 2013-04 PHASE4
NCT00406731 WITHDRAWN
Ocular Physiology; Optic Disk; Regional Blood Flow
Medical University of Vienna
 2008-01 PHASE2
NCT02245165 COMPLETED
Gastrointestinal Motility Disorder; Disturbance of Salivary Secretion
Uppsala University
 2013-06 PHASE1
NCT01617551 UNKNOWN
Essential Hypertension
Regional Hospital Holstebro
 2012-03
NCT00166166 TERMINATED
Hyperlipidemia
Emory University
 2002-07 PHASE2
NCT00690534 COMPLETED
Sarcopenia
The University of Texas Medical Branch, Galveston
 2005-09 PHASE1
NCT01290198 COMPLETED
Healthy Volunteers
University Hospital, Grenoble
 2011-02
NCT00914394 TERMINATED
Healthy
Medical University of Vienna
 2010-10
NCT00508989 COMPLETED
Sickle Cell Disease
National Heart, Lung, and Blood Institute (NHLBI)
 2007-07-24 PHASE2
NCT01060930 COMPLETED
Vascular Function in Healthy Volunteers
University of Edinburgh
 2010-03
NCT01070940 COMPLETED
Healthy
Regional Hospital Holstebro
 2010-02 PHASE1
NCT00806741 COMPLETED
Healthy
Medical University of Vienna
 2009-09
NCT00759707 COMPLETED
Peripheral Arterial Disease
Brigham and Women's Hospital
 2006-04
NCT00327080 TERMINATED
HIV
National Heart, Lung, and Blood Institute (NHLBI)
 2006-05-12 PHASE1
NCT00685945 COMPLETED
Obesity
Vanderbilt University
 2007-12
NCT00178919 COMPLETED
Hypertension; Pure Autonomic Failure
Vanderbilt University
 2002-08
NCT00072826 COMPLETED
Sickle Cell Disease
National Institutes of Health Clinical Center (CC)
 2003-11-04 PHASE1
NCT00095472 COMPLETED
Sickle Cell Anemia
National Heart, Lung, and Blood Institute (NHLBI)
 2004-11-01 PHASE1
NCT00185003 COMPLETED
Endotoxemia
Radboud University Medical Center
 2003-01 PHASE1
NCT00410085 COMPLETED
Obstructive Sleep Apnea; Healthy
Regional Hospital Holstebro
 2005-01 PHASE4
NCT00076414 COMPLETED
Healthy
National Institutes of Health Clinical Center (CC)
 2004-01 PHASE1
NCT00180063 COMPLETED
Healthy Subjects
Technische Universität Dresden
 2003-10
NCT00004575 COMPLETED
Healthy
National Heart, Lung, and Blood Institute (NHLBI)
 2000-02 PHASE1
NCT00048477 COMPLETED
Nitric Oxide; Endothelium-Derived Relaxing Factor; Healthy
National Heart, Lung, and Blood Institute (NHLBI)
 2002-10 PHASE2
NCT00344734 COMPLETED
Congestive Heart Failure
Regional Hospital Holstebro
 PHASE1
NCT00431665 COMPLETED
Renal Circulation; Renal Plasma Flow; Glomerular Filtration Rate; Fatty Acids, Nonesterified
Medical University of Vienna
 1999-07
NCT00009581 COMPLETED
Sickle Cell Anemia
National Institutes of Health Clinical Center (CC)
 2001-01 PHASE2
NCT00344916 COMPLETED
Liver Cirrhosis
Regional Hospital Holstebro
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-NMMA acetate acts as a competitive inhibitor of nitric oxide synthase, blocking the conversion of L-arginine into nitric oxide and subsequently diminishing downstream cyclic GMP-mediated vasodilation. This cellular attenuation of nitric oxide signaling regulates endothelial vascular tone, demonstrating clinical relevance in modulating hemodynamic parameters across cardiovascular, pulmonary, and metabolic conditions such as essential hypertension, heart failure, and hyperlipidemias.

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.