Clinical Trials

Numerous clinical trials evaluate sodium nitroprusside across Phase 1 through Phase 4 interventions and observational protocols for conditions such as essential hypertension, coronary microvascular disease, acute lung injury, acute respiratory distress syndrome, respiratory failure, hemodynamic control, and sarcopenia. Sponsored by academic institutions, university health centers, and commercial entities including Mount Sinai Hospital, Emory University, and GlaxoSmithKline, these studies encompass completed, actively recruiting, terminated, and withdrawn statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06424756 RECRUITING
Healthy
University of Georgia
 2024-07-01 PHASE2
NCT02560805 RECRUITING
Stress Disorders, Post-Traumatic
Emory University
 2015-10 PHASE2
NCT05193968 RECRUITING
Hot Flashes; Menopause; Vasomotor System; Labile
Mayo Clinic
 2022-02-24
NCT03318094 ACTIVE_NOT_RECRUITING
Insulin Resistance; Healthy; Obesity
Vanderbilt University Medical Center
 2017-10-24 PHASE1
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT04986072 TERMINATED
Schizophrenia; Schizoaffective Disorder
Beth Israel Deaconess Medical Center
 2022-03-14 PHASE2
NCT03679780 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction
The University of Texas at Arlington
 2018-10-01 PHASE1
NCT05525416 COMPLETED
Vasodilation; Vasoconstriction
University of Alberta
 2022-07-28
NCT04001647 TERMINATED
Vasodilation; Arterial Stiffness
Colorado State University
 2019-06-01 EARLY_PHASE1
NCT05277922 COMPLETED
Study Vasodilatory Effects of C21
Vicore Pharma AB
 2022-04-28 PHASE1
NCT05277922 Completed
Study Vasodilatory Effects of C21
Vicore Pharma AB|CTC Clinical Trial Consultants AB
 2022-04-28 Phase 1
NCT04928183 COMPLETED
Vasodilation; Vasoconstriction
University of Alberta
 2021-06-10
NCT03972683 WITHDRAWN
Vasoconstriction; Vasodilation
Colorado State University
 2019-04-16 EARLY_PHASE1
NCT03738943 COMPLETED
Receptor Blockade
Colorado State University
 2019-02-07 EARLY_PHASE1
NCT03953326 TERMINATED
Breast Cancer; Leukemia; Lymphoma
Penn State University
 2019-04-23 PHASE1; PHASE2
NCT04303689 Completed
Essential Hypertension
University of Copenhagen|University of Aarhus
 2020-08-01 Not Applicable
NCT03446612 TERMINATED
Anaemia
GlaxoSmithKline
 2019-01-10 PHASE2
NCT03680573 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction
The University of Texas at Arlington
 2018-01-08 PHASE1
NCT02767024 WITHDRAWN
Acute Heart Failure
Montefiore Medical Center
 2018-05-01 PHASE4
NCT03317652 COMPLETED
Healthy Male Subjects
Rigshospitalet, Denmark
 2017-11-03
NCT02164981 COMPLETED
Schizophrenia
Massachusetts General Hospital
 2015-05-01 PHASE2
NCT00580905 TERMINATED
Inflammation
Vanderbilt University
 2007-06 PHASE1
NCT04321434 Terminated
Coronary Microvascular Disease|Microvascular Disease|Ischemic Heart Disease
Université Libre de Bruxelles
 2016-12-01 Not Applicable
NCT01395329 COMPLETED
Prehypertension; Hypertension
University of Colorado, Boulder
 2011-05 PHASE4
NCT02176044 COMPLETED
Schizophrenia
King's College London
 2014-08 PHASE1
NCT00891696 COMPLETED
Sarcopenia
The University of Texas Medical Branch, Galveston
 2009-04 PHASE1
NCT01747174 COMPLETED
ST-elevation Myocardial Infarction (STEMI)
University Hospitals, Leicester
 2011-10 PHASE2
NCT01619280 UNKNOWN
Acute Lung Injury; Acute Respiratory Distress Syndrome; Sodium Nitroprusside; Hypoxia; Respiratory Failure
Mount Sinai Hospital, Canada
 2012-05 PHASE1
NCT00166166 TERMINATED
Hyperlipidemia
Emory University
 2002-07 PHASE2
NCT01333891 TERMINATED
Healthy
Medical University of Vienna
 2012-12
NCT00690534 COMPLETED
Sarcopenia
The University of Texas Medical Branch, Galveston
 2005-09 PHASE1
NCT00621816 COMPLETED
Hypertension
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2009-01 PHASE2
NCT00901719 COMPLETED
Heart Disease; Heart Failure; Vasodilatation
University of Edinburgh
 2010-04
NCT00901888 COMPLETED
Heart Disease; Vasodilation
University of Edinburgh
 2009-04
NCT02085317 COMPLETED
Lepromatous Leprosy
Curt Treu
 2006-03
NCT01548612 COMPLETED
Schizophrenia
University of Sao Paulo
 2006-02 PHASE2
NCT00945256 COMPLETED
Aging
The University of Texas Medical Branch, Galveston
 2003-05 PHASE1
NCT00135668 COMPLETED
Hypotension
The Emmes Company, LLC
 2005-08 PHASE2
NCT00636584 UNKNOWN
Nitroprusside; Thyroid Hormones
Kavaklıdere Umut Hospital
 2008-02 PHASE4
NCT00093912 COMPLETED
Hypertension
The Medicines Company
 2004-06 PHASE3
NCT00810381 COMPLETED
Glaucoma
Medical University of Vienna
 1999-01
NCT00253929 COMPLETED
Blood Flow in Healthy Volunteers
Radboud University Medical Center
 2005-11
NCT00160888 UNKNOWN
Healthy
Heidelberg University
 1999-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-12-09)

Check the Sodium Nitroprusside Dihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium nitroprusside spontaneously breaks down in vascular tissue to release nitric oxide, which directly activates soluble guanylyl cyclase and increases intracellular cyclic guanosine monophosphate synthesis. Increased cyclic guanosine monophosphate lowers intracellular calcium concentration within vascular smooth muscle cells to induce arterial relaxation, providing rapid vasodilation that addresses cardiovascular conditions such as hypertension and acute lung injury evaluated in clinical trials.

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.