Active Ingredient History
In mammals Nitric Oxide (NO) is an important cellular signaling molecule involved in many physiological and pathological processes. It is a powerful vasodilator with a short half-life of a few seconds in the blood. Low levels of nitric oxide production are important in protecting organs such as the liver from ischemic damage. Nitric oxide production is associated with nonalcoholic fatty liver disease (NAFLD) and is essential for hepatic lipid metabolism under starvation. Nitric oxide (INOmax) is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Nitric oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, nitric oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature. INOmax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better-ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios. NO, can be generated in large quantities and has detrimental effects on the CNS. NO has been shown to increase permeability of the BBB, allowing substances to enter into the brain passively. Because of its importance in neuroscience, physiology, and immunology, NO was proclaimed "Molecule of the Year" in 1992. Research into its function led to the 1998 Nobel Prize for discovering the role of nitric oxide as a cardiovascular signaling molecule (Furchgott, Murad and Ignarro). NCATS
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Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Hypertension, Pulmonary (approved 1999)
Acidosis, Respiratory (Phase 1/Phase 2)
Acute Chest Syndrome (Phase 2/Phase 3)
Acute Kidney Injury (Phase 3)
Anemia (Phase 1/Phase 2)
Anemia, Sickle Cell (Phase 2/Phase 3)
Asthma (Phase 4)
Blood Platelet Disorders (Phase 2/Phase 3)
Blood Transfusion (Phase 2)
Brain Injuries, Traumatic (Phase 3)
Bronchiolitis (Phase 3)
Bronchopulmonary Dysplasia (Phase 3)
Candidiasis, Oral (Phase 1)
Cardiac Output, Low (Phase 3)
Cardiomyopathies (Phase 3)
Cardiopulmonary Bypass (Phase 1/Phase 2)
Cardiovascular Diseases (Phase 2)
Cerebral Intraventricular Hemorrhage (Phase 2/Phase 3)
Cerebrovascular Disorders (Phase 1)
Chest Pain (Phase 2)
Child Behavior (Phase 3)
Colorectal Neoplasms (Phase 1)
Coronary Artery Bypass (Phase 1/Phase 2)
Coronary Artery Disease (Phase 1/Phase 2)
Coronary Disease (Phase 2)
Coronavirus (Phase 2)
Coronavirus Infections (Phase 2)
COVID-19 (Phase 3)
Cross Infection (Phase 2)
Cystic Fibrosis (Phase 2)
Diabetic Foot (Phase 3)
Dyspnea (Phase 2)
Endothelial Cells (Phase 2)
Endothelium (Phase 2)
Familial Primary Pulmonary Hypertension (Phase 3)
Fontan Procedure (Phase 3)
Gastroesophageal Reflux (Phase 1)
General Surgery (Phase 3)
Healthy Volunteers (Phase 2)
Heart Arrest (Phase 2)
Heart Defects, Congenital (Phase 3)
Heart Disease Risk Factors (Phase 2)
Heart Diseases (Phase 3)
Heart Failure (Phase 4)
Heart Transplantation (Phase 2)
Heart Valve Diseases (Phase 1/Phase 2)
Hemolysis (Phase 2)
Hernias, Diaphragmatic, Congenital (Phase 4)
Hypertension, Pulmonary (Phase 4)
Hypertrophy, Left Ventricular (Phase 2)
Hypoxia (Phase 3)
Hypoxia-Ischemia, Brain (Phase 1/Phase 2)
Idiopathic Pulmonary Fibrosis (Phase 2)
Infant (Phase 4)
Infant, Low Birth Weight (Phase 3)
Infant, Newborn (Phase 3)
Infant, Premature (Phase 3)
Infant, Premature, Diseases (Phase 2/Phase 3)
Infant, Small for Gestational Age (Phase 3)
Inflammation (Phase 2/Phase 3)
Leg Ulcer (Phase 1/Phase 2)
Leishmaniasis, Cutaneous (Phase 3)
Leukomalacia, Periventricular (Phase 2/Phase 3)
Liver Diseases (Phase 2/Phase 3)
Lung Diseases (Phase 3)
Lung Transplantation (Phase 2)
Malaria (Phase 1/Phase 2)
Malaria, Cerebral (Phase 2)
Molluscum Contagiosum (Phase 3)
Mycobacterium Infections, Nontuberculous (Phase 2)
Myocardial Infarction (Phase 2)
Myocardial Ischemia (Phase 2)
Myocardial Reperfusion Injury (Phase 1/Phase 2)
Neoplasms (Phase 1)
Neuralgia (Phase 2)
Nitric Oxide (Phase 2)
Out-of-Hospital Cardiac Arrest (Phase 2)
Oxidative Stress (Phase 2)
Oxygen Saturation (Phase 2)
Pain (Phase 4)
Persistent Fetal Circulation Syndrome (Phase 4)
Pneumonia (Phase 3)
Pneumonia, Aspiration (Phase 3)
Pneumonia, Viral (Phase 2)
Postoperative Complications (Phase 2)
Prehypertension (Phase 1/Phase 2)
Premature Birth (Phase 4)
Pressure Ulcer (Phase 1/Phase 2)
Psoriasis (Phase 1)
Pulmonary Arterial Hypertension (Phase 3)
Pulmonary Diffusing Capacity (Phase 1)
Pulmonary Disease, Chronic Obstructive (Phase 2)
Pulmonary Embolism (Phase 2)
Pulmonary Fibrosis (Phase 2)
Renal Insufficiency, Chronic (Phase 1/Phase 2)
Reperfusion Injury (Phase 3)
Respiratory Distress Syndrome (Phase 3)
Respiratory Distress Syndrome, Newborn (Phase 3)
Respiratory Insufficiency (Phase 4)
Respiratory Tract Infections (Phase 2)
Retinopathy of Prematurity (Phase 3)
Sarcoidosis, Pulmonary (Phase 2)
Sepsis (Phase 3)
Severe Acute Respiratory Syndrome (Phase 2)
Shock, Septic (Phase 1)
Sinusitis (Phase 2)
Skin Ulcer (Phase 2)
ST Elevation Myocardial Infarction (Phase 2)
Stroke (Phase 2)
Thoracic Surgery (Phase 1/Phase 2)
Tinea (Phase 2)
Tinea Pedis (Phase 2)
Transposition of Great Vessels (Phase 3)
Ulcer (Phase 2)
Varicose Ulcer (Phase 2)
Vasoconstriction (Phase 1)
Ventricular Dysfunction, Left (Phase 3)
Walk Test (Phase 2)
Trial | Phase | Start Date | Organizations | Indications |
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