U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 261 - 270 of 462 results

Status:
Possibly Marketed Outside US
Source:
NCT01904396: Phase 4 Interventional Unknown status Carnitine Deficiency
(2013)
Source URL:
First approved in 2009

Class (Stereo):
CHEMICAL (RACEMIC)

Conditions:

L-carnitine (L-beta-hydroxy-gamma-N,N,N-trimethylaminobutyric acid) is conditionally necessary for mitochondrial transport and metabolism of long-chain fatty acids, and thus for myocardial energetic metabolism. D-carnitine is not biologically active and might interfere with proper utilization of the L isomer, and so there are claims that the racemic mixture (DL-carnitine) should be avoided. The pharmacological effects of carnitine are stereospecific: L-carnitine was effective in various animal and clinical studies, while D- and DL-carnitine was found to be ineffective or even toxic to some cells and tissues, such as muscle cells and the myocardium. DL-carnitine caused symptoms of myasthenia and cardiac arrhythmias, which disappeared after L-carnitine administration.
Status:
Possibly Marketed Outside US
Source:
Japan:Adenosine 5'-Triphosphate Disodium
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)


Adenosine triphosphate (ATP) is an adenine nucleotide containing three phosphate groups esterified to the sugar moiety. Adenosine triphosphate is the energy source in living cells. In physiological conditions, the average concentration varies from 3150 mM in mammalian cells to 1500–1900 mM in human blood cells. Extracellular adenosine and adenosine triphosphate (ATP) are involved in biological processes including neurotransmission, muscle contraction, cardiac function, platelet function, vasodilatation, signal transduction and secretion in a variety of cell types. A large family of membrane-bound receptors mediates cell signalling by ATP and adenosine. These purinergic receptors ultimately determine the variety of effects induced by extracellular ATP and adenosine. ATP and adenosine have strong negative chronotropic and dromotropic effects on the mammalian heart. The sensitivity of the sinus node and the atrioventricular node to ATP and adenosine manifests pronounced variability among species. For more than three decades, ATP has been used routinely in Europe in the acute therapy of paroxysmal supraventricular tachycardia. ATPace™, an injectable formulation of adenosine 5′-triphosphate (ATP), was developed by Cordex Pharma, Inc. (Cordex) as a diagnostic and therapeutic drug for the management of cardiac bradyarrhythmias. Extracellular ATP exerts multiple effects in various cell types by activating cell-surface receptors known as P2 receptors. In the heart, ATP suppresses the automaticity of cardiac pacemakers and atrioventricular (AV) nodal conduction via adenosine, the product of its degradation by ecto-enzymes, as well as by triggering a cardio-cardiac vagal reflex. ATP, given as a rapid intravenous bolus injection, has been used since the late 1940s as a highly effective and safe therapeutic agent for the acute termination of reentrant paroxysmal supraventricular tachycardia (PSVT) involving the AV node. In addition, preliminary studies have shown that ATP can also be used as a diagnostic agent for the identification of several cardiac disorders including sinus node dysfunction (sick sinus syndrome), dual AV nodal pathways, long QT syndrome, and bradycardic syncope. The US Food and Drug Administration has approved Cordex formulation for ATP as an Investigational New Drug and two pathways for its marketing approval; one therapeutic, i.e., acute termination of paroxysmal PSVT, and the other diagnostic, i.e., the identification of patients with bradycardic syncope who can benefit from pacemaker therapy. However later ATPace development for the treatment of bradycardia and paroxysmal supraventricular tachycardia was discontinued.
Status:
Possibly Marketed Outside US
Source:
NCT03915535: Phase 4 Interventional Terminated Healthy Athletes
(2019)
Source URL:
First approved in 2007

Class (Stereo):
CHEMICAL (ACHIRAL)



Doconexent (Docosahexaenoic acid, DHA) is an omega-3 fatty acid that is a primary structural component of the human brain, cerebral cortex, skin, and retina. DHA is widely used as a food supplement, and is beleived to support healthy brain development in young childred, prevent cardiovascular disease and cognitive decline during Alzheimer's disease. Most of these claims, however, were not supported by clinical trials. DHA spray is used as a tanner.
Status:
Possibly Marketed Outside US
Source:
NCT02587117: Phase 4 Interventional Completed Oral Lichen Planus
(2013)
Source URL:
First approved in 2007
Source:
Corvite Free by Vertical Pharmaceuticals, LLC
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Lycopene is the fat-soluble pigment that gives tomatoes, watermelon, pink grapefruit, and other foods their red color. Bioavailability of lycopene is enhanced in the presence of lipids and thermal processing. Lycopene accounts for about 50% of the carotenoids found in human serum and is among the major carotenoids present in human milk. The antioxidant activity of lycopene and its use in cancer prevention and cardiovascular disease have been widely documented. The scientific literature documents some adverse reactions, such as diarrhea, dyspepsia, gas, nausea, and vomiting. One trial documented a cancer-related hemorrhage in a patient taking lycopene, although causality is unclear. Lycopene interacts with some cancer chemotherapy agents, as well as with ciprofloxacin and olestra.
Status:
Possibly Marketed Outside US
Source:
CFR:21 CFR 310.201
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Gentisic acid is an active metabolite of salicylic acid degradation, which possesses a broad spectrum of biological activity, such as anti-inflammatory, antirheumatic and antioxidant properties. The antioxidant activity and radioprotective properties of gentisic acid are exerted by its phenoxyl group. It is also used in cosmetics as a skin-whitening agent for the treatment of skin pigmentary disorders by influencing the synthesis of melanin through inhibition of melanosomal tyrosinase activity Gentisic acid is also a biomarker of Renal Cell Carcinoma.
Status:
Possibly Marketed Outside US
Source:
Remedient by Levins Pharmaceuticals, LLC
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)



Carnosine is a dipeptide composed of the amino acids beta-histidine and l-alanine. It is widely present in muscle and brain tissues. It possesses strong and specific antioxidant properties, protects against radiation damage, and promotes wound healing. The antioxidant mechanism of carnosine is attributed to its chelating effect against metal ions, superoxide dismutase (SOD)-like activity, ROS and free radicals scavenging ability. In addition, was shown, that carnosine significantly protects against TCA-induced liver carcinogenesis in rats, through its antioxidant, antinutritive, and anti-inflammatory effects, and induction of apoptosis. It also may be a therapeutic agent against Parkinson's disease. Experiments on animal have shown the sepsis healing therapeutic potential of carnosine.
Status:
Possibly Marketed Outside US
Source:
NCT02356107: Phase 4 Interventional Completed Major Depressive Disorder
(2015)
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Creatine is an amino acid that occurs in vertebrate tissues and in urine. It is synthesized mainly in the liver from three different amino acids: arginine, glycine, and methionine. In skeletal muscles, which store 95% of it, creatine generally occurs as phosphocreatine. The rest is stored in the brain, heart, and testes. Creatine functions as part of the cell's energy shuttle. It is excreted as creatinine in the urine.
Glutathione (GSH, also called as reduced glutathione) is a tripeptide with many roles in cells. It conjugates to drugs to make them more soluble for excretion, is a cofactor for some enzymes such as, glutathione reductase, glutathione peroxidases, peroxiredoxins. Glutathione S-transferases catalyse the conjugation of GSH via a sulfhydryl group to electrophilic centers on a wide variety of substrates in order to make the compounds more water-soluble. As a part of homeopathic product, glutathione is used for temporary relief of symptoms related to Free Radical Toxicity including tingling in hands and feet, mood changes, frequent colds, poor digestion, fatigue, and constipation. In addition, for temporary relief of pain in the back from urinating, constant urging and frequent urination, kidneys sensitive to pressure, and pain from back extending down the thigh. Glutathione is an important nutrient for brain function and loss of glutathione has been implicated in Parkinson's disease. In phase II of the clinical trial was investigated whether administration of either dose of glutathione, as a nasal spray, improves PD symptoms over time in a population of individuals with Parkinson's disease (PD). In addition in phase II of clinical trial was shown, that reduced glutathione, an ingredient of RayGel™, has been helpful in decreasing some radiation therapy side effects to the skin. Reduced glutathione plays a vital role in both making DNA and cell repair. Cystic fibrosis (CF) is the most common inherited disease among the Caucasian population with considerable morbidity and reduced life expectancy. Glutathione (GSH) represents the first-line defence of the lung against oxidative stress-induced cell injury. Therapeutic approaches with inhaled GSH could improve the reduced lung antioxidant capacity in order to counterbalance the oxidant stress linked to the chronic airway inflammation and bacterial infection.
Squalene is a naturally occurring polyprenyl compound primarily known for its key role as an intermediate in cholesterol synthesis. It received its name because of its occurrence in shark liver oil (Squalus spp.), which contains large quantities and is considered the richest source of squalene. However, it is widely distributed in nature, with reasonable amounts found in olive oil, palm oil, wheat-germ oil, amaranth oil, and rice bran oil. The primary therapeutic use of squalene currently is as an adjunctive therapy in a variety of cancers. Although epidemiological, experimental and animal evidence suggests anti-cancer properties, to date no human trials have been conducted to verify the role this nutrient might have in cancer therapy regimens.

Showing 261 - 270 of 462 results