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Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Nerolidol (aka peruviol) is a naturally occurring sesquiterpene found in the essential oils of many types of plants and flowers. The aroma of nerolidol is woody and reminiscent of fresh bark. It is used as a flavoring agent and in perfumery. It is also used in non-cosmetic products such as detergents and cleansers. Additionally, it is known for several biological activities including antioxidant, anti-fungal, anticancer, and antimicrobial activities.
Status:
Possibly Marketed Outside US
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Butyric acid (butanoic acid) belongs to a group of short-chain fatty acids and is thought to play several beneficial roles in the gastrointestinal tract. The butyric anion is easily absorbed by enteric cells and used as a main source of energy. Moreover, butyric acid is an important regulator of colonocyte proliferation and apoptosis, gastrointestinal tract motility and bacterial microflora composition in addition to its involvement in many other processes including immunoregulation and anti-inflammatory activity. Butyric acid shows a protective effect in inflammatory
response secondary to inflammatory bowel diseases. A beneficial effect of butyric acid as one constituent
of a multifaceted mechanism modulating gastrointestinal
function has also been stressed in patients with the stoma
and coexisting constipation. Butyric acid supplementation
combined with the use of probiotics should be adopted
as one of the basic therapeutic strategies in this
patient group, preceding treatment with laxatives. Sodium butyrate in the form of enemas (combined
in a mixture with A-300 silicon dioxide) may be a successful
method of therapeutic management in patients
with radiation proctitis. Sodium butyrate may also prevent diarrhea
through an increased passive absorption of water in the
colon and its effects on the gut microflora.
Status:
Possibly Marketed Outside US
First approved in 2019
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Fosfructose is a cytoprotective natural sugar phosphate under development by Questcor (formerly Cypros) for the potential treatment of cardiovascular ischemia, sickle cell anemia and asthma. Fosfructose acts by stimulating anaerobic glycolysis which generates adenosine triphosphate under ischemic conditions and improve the cellular energy metabolism in ischemic and hypoperfused tissues. Hypoxia forces ischemic tissue to anaerobic glycolysis for energy, which yields two molecules of ATP per glucose in contrast to 36 molecules of ATP generated during oxidative phosphorylation . Addition of exogenous Fosfructose can produce two more molecules of ATP in an uncompensated anaerobic environment and hence facilitate the recovery of ischemia tissue. Fosfructose breaks down into glyceraldehyde-3-phosphate and dihydroxyacetone phosphate, which will further break down into two molecules of pyruvate and finally produce two molecules of ATP. Other mechanisms include inhibition of the generation of oxygen free radicals by neutrophils, stabilization of cell membranes, and maintainance of the correct xanthine dehydrogenase/oxidase ratio by preventing the depletion of phosphorylated compounds in ischemic tissues. In myocardial infarction patients, FDP can improve the hemodynamic parameters, attenuate ECG proven ischemic injury and arrhythmia, prevent ATP and creatine phosphate depletion from ischemic myocardium, reduce infarct size, and increase survival rate. Exogenously administered Fosfructose has also been proven beneficial for a variety of other ischemic organs, such as liver, kidney, bowel and even brain as a consequence of its ability to penetrate to the blood brain barrier. Fosfructose trisodium had been in phase I clinical trials for the treatment of heart transplant rejection. Fosfructose trisodium had been in phase II clinical trials for the treatment of heart failure, perioperativ eischaemia and reperfusion injury. Fosfructose trisodium had been in phase III clinical trials for the treatment of sickle cell anaemia. However, all these research has been discontinued. In China, FDP has been approved and marketed as a commercial drug.
Status:
Possibly Marketed Outside US
Source:
NCT01056042: Phase 4 Interventional Completed Endometriosis
(2007)
Source URL:
First approved in 2018
Source:
MYVLAR by OASIS TRADING
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Gestodene (17alpa-ethynyl-13beta-ethyl-17beta-hydroxy-4,15-gonadien-3-one) is the most potent synthetic progestin currently available and it is widely used as a fertility regulating agent in a number of contraceptive formulations because of its high effectiveness, safety and acceptability. Products containing gestoden include Meliane, which contains 20 ug of ethinylestradiol and 75 ug of gestodene; and Gynera, which contains 30 ug of ethinylestradiol and 75 ug of gestodene. Gestodene is androgenically neutral, meaning that contraceptive pills containing gestodene do not exhibit the androgenic side effects (e.g. acne, hirsutism, weight gain) often associated with second-generation contraceptive pills. Gestodene displays a high binding affinity to the progesterone receptor, also binds to adrogen and glucocorticoid receptors but no measurable affinity for the estrogen receptor.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2016)
Source URL:
First approved in 2016
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Allantoin is a metabolic intermediate of a wide variety of organims: from bacteria to vegetals and animals. Allantoin is a skin active ingridient with keratolytic, moisturizing, anti-irritant properties, promotes renewal of epidermal cell and accelerates wounds healing. Allantoin possesses one chiral center thereby exists in the two enantiomeric forms R-(-) and S-( ). Enzymes that catalyze the formation of (S)-allantoin from the product of the urate oxidase reaction have been identified. The two proteins encoded by mouse genes catalyze two consecutive steps following urate oxidation to 5-hydroxyisourate (HIU): hydrolysis of HIU to give 2-oxo-4-hydroxy-4-carboxy-5-ureidoimidazoline (OHCU) and decarboxylation of OHCU to give S-( )-allantoin. Urate oxidation produces racemic allantoin on a time scale of hours, whereas the full enzymatic complement produces dextrorotatory allantoin on a time scale of seconds. Scioderm is developing Allantoin (Zorblisa; SD-101), as a novel topical therapy for patients with epidermolysis bullosa.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
M017
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Nonivamide is an organic compound and a capsaicinoid. It is an amide of pelargonic acid (n-nonanoic acid) and vanillyl amine. It is present in chili peppers, but is commonly manufactured synthetically. Nonivamide (trade name Finalgon ) is used in topical ointments and creams to relieve minor aches and pains of muscles and joints. Nonivamide is also available in large adhesive bandages that can be applied to the back. Concentrations are typically between 0.025% and 0.075%. Nonivamide is a TRPV1 ion channel agonist.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
Rebound by Activon
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Troclosene is chlorinated hydroxytriazine and it is used as a source of free available chlorine, in the form of hypochlorous acid, for the disinfection of water. It kills bacteria, bacterial spores, cysts, algae, fungi, protozoa and virus and are especially lethal to Entamoeba histolytica. Troclosene kills mastitis-causing organisms. It is now widely available for household water treatment. It does not prevent diarrhea but improved water quality.
Status:
Possibly Marketed Outside US
Source:
ANDA218073
(2013)
Source URL:
First approved in 2013
Source:
ANDA218073
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Tetraxetan (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (also known as DOTA) is used as a complexing agent. Its complexes have medical applications as contrast agents and cancer treatments. DOTA can be conjugated to monoclonal antibodies by attachment of one of the four-carboxyl groups as an amide. The modified antibody accumulates in the tumour cells, concentrating the effects of the radioactivity of 90Y. DOTA can also be linked to molecules that have an affinity for various structures. The resulting compounds are used with a number of radioisotopes in cancer therapy and diagnosis. Clivatuzumab tetraxetan is a humanized monoclonal antibody targeting a mucin antigen expressed in most pancreatic cancers, but not pancreatitis, normal pancreas or most other normal tissues. Preclinical studies in mice with human pancreatic cancer xenografts given the murine version of 90Y-clivatuzumab tetraxetan demonstrated favourable tumour responses, which could be further improved when given in combination with gemcitabine. (64)Cu-DOTA-trastuzumab PET (positron emission tomography) could be a potential noninvasive procedure for serial identification of metastatic brain lesions in patients with HER2-positive breast cancer. 90Y-DOTA-biotin may have the application of pre-targeted radioimmunotherapy for the treatment of advanced colorectal cancer in humans.
Status:
Possibly Marketed Outside US
Source:
NCT03199430: Phase 4 Interventional Completed EGCG Influence on Catecholamine Metabolism
(2015)
Source URL:
First approved in 2012
Source:
BabySpaShea Butter Diaper by EXPRO3 LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Epigallocatechin-3-gallate (EGCG), the major polyphenol from green tea, has the potential to impact a variety of human diseases. EGCG functions as a powerful antioxidant, preventing oxidative damage in healthy cells, but also as an antiangiogenic and antitumor agent and as a modulator of tumor cell response to chemotherapy. It was shown, that EGCG can inhibit 5-cytosine DNA methyltransferase (DNMT) activity and reactivate methylation-silenced genes in cancer cells and another of the probable mechanisms by EGCG exercise their anti-tumor property is through the suppression of the NFκB signaling pathway. EGCG has emerged as a potential neuroprotective agent for the treatment of neurological disorders associated with harmful effects of reactive oxygen species. The neuroprotective mechanism of action is probably based on several factors, including EGCG's modulation of several signal transduction pathways, its influence on the expression of genes regulating cell survival or programmed cell death, as well as its modulation of mitochondrial function. A phase II/III trial of oral Sunphenon epigallocatechin-3-gallate in patients with progressive multiple sclerosis has been completed. In addition, EGCG was in phase III clinical trials for the treatment of multiple system atrophy and for patients with Duchenne Muscular Dystrophy ((DMD). DMD is the most frequent neuromuscular condition to occur in childhood and youth.
Status:
Possibly Marketed Outside US
Source:
NCT03384329: Phase 4 Interventional Completed Depression
(2018)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Resveratrol, a natural non-flavonoid polyphenol, exhibits a wide range of beneficial properties as an anticancer agent, a platelet anti-aggregation agent, and an antioxidant, as well as its anti-aging, anti-inflammatory, antiallergenic. This compound is in phase III clinical trials in combination with carboxymethyl-β-glucan for improving nasal symptoms in children with pollen-induced allergic rhinitis. Also in phase III clinical trial in the treatment of painful knee osteoarthritis and in type 2 diabetic patients. It has been demonstrated that resveratrol may prevent type 2 diabetic by targeting Sirtuin type 1 (SIRT1), indicating that SIRT1 may be a novel therapeutic target for diabetes prevention.