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Search results for "ORPHAN DRUG" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
NCT03626298: Phase 4 Interventional Completed Acne Vulgaris
(2016)
Source URL:
First approved in 2002
Source:
M006
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Zinc Pidolate (Zinc PCA) is a topical skin product with purifying, astingent, anti-inflammatory, antiseptic activity. It has long been used as a cosmetic ingredient, because of its astringent and anti-microbial properties. Zinc Pidolate has also being shown to be effective against halitosis. Zinc PCA prevents the UV-induced MMP-1 production in vitro by suppressing the activation of AP-1. Zinc PCA was also able to enhance type I collagen synthesis in NHDFs, by increasing the expression of the mRNA encoding the ascorbic acid transporter SVCT2 in non-UV irradiated
NHDFs, which suggests its promising effect against not only photoaged skin but also for the simple atrophic change of intrinsic skin ageing. Zinc PCA is able to suppress sebum secretion by inhibiting 5-α reductase in hyperseborrhea, to suppress body odor by forming zinc salts with short-chain fatty acids, to suppress wrinkles by inhibiting AP-1 to and inhibit bacterial growth including acne related Propionibacterium acnes.
Status:
Possibly Marketed Outside US
First approved in 2002
Source:
NDA207202
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Gold chloride (AUCl3), dihydrate, also called gold trichloride or auric chlorise, is a compound comprised of gold and chloride. It exists as a chloride-bridged dimer, both as a solid and as a vapor. AUCl3 is very hygroscopic and highly soluble in water and ethanol. It is used in organic chemistry as a mild acid catalyst and as a alternative to mercury salts. It is known to cause allergic reactions in subjects with known gold allergy.
Status:
Possibly Marketed Outside US
Source:
Axona by Accera
Source URL:
First approved in 2002
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Tricaprylin is a triester of glycerin and caprylic acid. It is used as a fragrance ingredient, solvent, and primarily as an emollient in a variety of personal care products, including makeup, creams and lotions, deodorants, sunscreens, hair conditioners, and skin cleansers. Tricaprylin is an ingredient of Axona, a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease. Axona provides a simple and safe method to induce hyperketonemia, thus providing an alternative energy substrate to glucose in the brain of patients with AD. After oral administration of Axona, Tricaprylin in Axona is processed by enzymes in the gut, and the resulting medium-chain fatty acids (MCFAs) are absorbed into the blood supply leading to the liver. The MCFAs rapidly pass directly to the liver, where they undergo oxidation to form ketones. Since the liver does not use ketones, they are released into the circulation to be used by nonliver tissues. Some ketones can cross the blood-brain barrier and are then taken up by brain cells. While glucose is the brain’s chief energy source, ketones normally serve as the "backup" energy source. Ketones the body produces after Axona is consumed, act as an alternative energy source for brain cells that have lost their ability to use glucose (sugar) as a result of Alzheimer’s disease.
Status:
Possibly Marketed Outside US
Source:
ANDA206398
(2002)
Source URL:
First approved in 2001
Source:
NDA020919
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
NCT04475276: Phase 4 Interventional Recruiting Non-Alcoholic Fatty Liver Disease
(2021)
Source URL:
First approved in 2001
Source:
Strovite OneCaplets by Exeltis USA, Inc.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Thioctic acid also known as alpha-lipoic acid is a dietary supplement, which is a common ingredient in OTC (over-the-counter) multivitamin formulas and anti-aging supplements. Thioctic acid exists in both R- and S-enantiomeric forms, however, only R-form is essential as a cofactor in biological systems (the acid is coupled via an amide linkage to a lysine of several multienzyme complexes, such as the pyruvate dehydrogenase complex, the alpha-ketoglutarate dehydrogenase complex, the glycine cleavage system and the branched-chain oxo acid dehydrogenase complex). Most commercially available thioctic acid supplements are a mixture of both R and S enantiomers or R-form alone. Several studies have shown that the acid has beneficial effect on diabetes complications, cancer, glaucome, liver disease, etc. The mechanisms of thioctic acid is related to its antioxidant properties, metal chelator properties, however, those mechanisms need futher confirmation.
Status:
Possibly Marketed Outside US
First approved in 2000
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Borneol, a monoterpenoid alcohol, is a component of many essential oils. Barneol occurs in nature as a single enantiomer (d- or l-, depending on the oil type) or, less frequently, as the racemate. Several studies have proved the effectiveness of borneol. In Chinese medicines borneol has been used in relieving symptoms of anxiety, fatigue and insomnia; inducing anesthesia and analgesia to alleviate abdominal pain, wounds and burns; relieving rheumatic pain, hemorrhoids, skin diseases and ulcerations of the mouth, ears, eyes or nose; to treat sore throats and skin infections, and is mainly used to treat cardiovascular and cerebrovascular diseases. Borneol has a significant therapeutic effect on neuralgia. This compound is considered a GRAS approved by the FDA as food flavor. Additionally, borneol is a fragrance ingredient. GABAA, TRPV3, TRPM8 and TRPA1 have been identified as the molecular targets of borneol.
Status:
Possibly Marketed Outside US
Source:
NCT02644707: Phase 4 Interventional Completed Autoimmune Thyroiditis
(2014)
Source URL:
First approved in 2000
Source:
BACMIN by Marnel Pharmaceuticals, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
L-isomer of selenomethionine (Se-met) is a major natural food-form of selenium, synthetic L-Se-met or enriched food sources thereof such as selenium yeast are appropriate supplemental forms of Se for humans; for animals, DL-Se-met is acceptable. Ingested Se-met is either metabolized directly to reactive forms of selenium or stored in place of methionine in body proteins. Se-met metabolism is closely linked to protein turnover. Selenium, which is nutritionally essential for humans, is a constituent of more than two dozen selenoproteins that play critical roles in reproduction, thyroid hormone metabolism, DNA synthesis, and protection from oxidative damage and infection.
Status:
Possibly Marketed Outside US
Source:
NDA022527
(2010)
Source URL:
First approved in 1997
Source:
NDA020657
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Status:
Possibly Marketed Outside US
Source:
NDA020657
(1997)
Source URL:
First approved in 1997
Source:
NDA020657
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Status:
Possibly Marketed Outside US
Source:
NCT00894153: Phase 4 Interventional Unknown status Neoplasms
(2009)
Source URL:
First approved in 1996
Source:
NDA020372
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Tetrofosmin is a phosphor-organic compound, belonging to the group of diphosphines. Tetrofosmin is used as a component of a Technetium (99mTc) tetrofosmin complex. Due to the relatively short half-life of Tc99m (6 hours), just before the administration, the solution of tetrofosmin should be reconstituted with Tc99m pertechnetate to form a complex of Tc99m Tetrofosmin. When administered intravenously, Tc99m Tetrofosmin shows rapid myocardial uptake and its distribution follows a linear relationship with coronary blood flow. It is taken up by the mitochondria of myocardial cells by passive diffusion and appears to accumulate in viable myocardial tissue. Tc99m Tetrofosmin is used as a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function.