Clinical Trials

Numerous clinical trials evaluate sodium nitroprusside across all developmental phases, from Early Phase 1 to Phase 4, for a range of cardiovascular, respiratory, oncological, and physiological conditions such as hypertension, acute respiratory distress syndrome, non-small cell lung cancer, and sarcopenia. Sponsored by academic medical centers, government agencies, and pharmaceutical companies, these studies represent various recruitment statuses including completed, actively recruiting, terminated, and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
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
NCT06405945 Recruiting
Cervical Cancer Susceptible Population Classification
Anhui Provincial Hospital
2024-05-01 --
NCT05987956 Not yet recruiting
Non-small Cell Lung Cancer
Han Xu M.D. Ph.D. FAPCR Sponsor-Investigator IRB Chair|Medicine Invention Design Inc
2024-03-08 Phase 2|Phase 3
NCT06062810 Not yet recruiting
Non-Small Cell Lung Cancer
Han Xu M.D. Ph.D. FAPCR Sponsor-Investigator IRB Chair|Medicine Invention Design Inc
2024-03-28 Phase 2|Phase 3
NCT06265623 Not yet recruiting
Chronic Obstructive Pulmonary Disease (COPD)
Universitätsklinikum Hamburg-Eppendorf
2024-03-01 --
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
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
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
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 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium nitroprusside acts as a nitric oxide donor that activates soluble guanylyl cyclase in vascular smooth muscle cells, driving the intracellular accumulation of cyclic guanosine monophosphate and activation of downstream protein kinase G signaling. This physiological cascade induces potent vascular smooth muscle relaxation and systemic vasodilation, effectively reducing peripheral vascular resistance to manage hypertensive crises and improve pulmonary hemodynamics in patients with acute lung injury and respiratory failure.

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.