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Restrict the search for
bempedoic acid
to a specific field?
Status:
Possibly Marketed Outside US
Source:
505G(a)(3)
(2017)
Source URL:
First approved in 2017
Source:
505G(a)(3)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
NDA213051
(2017)
Source URL:
First approved in 2017
Source:
NDA213051
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Salcaprozate sodium (SNAC), an oral absorption promoter that was discovered as part of a screen to identify carrier-based permeation enhancers (Pes) that could “chaperone” poorly permeable payloads across the intestine. Its potential therapeutic application as a delivery agent was tested in many formats: taste-masked liquids, tablets, and soft gelatin capsules. SNAC is the most extensively tested carrier and the only PE approved in an oral formulation designed to improve oral bioavailabilities. The mechanism of action of this compound is not clear. However, Novo Nordisk offered a mechanism of action for SNAC in its non-enteric coated tablet of the glucagon-like peptide 1 analog, semaglutide. SNAC formed a complex around the semaglutide in the stomach and caused a transient increase in local pH around the molecule. It is claimed that semaglutide is protected against pepsin by SNAC and that solubility was increased, resulting in an increased concentration-dependent flux of semaglutide across the gastric mucosa, using a transcellular mechanism as the tablet comes in intimate contact with the epithelium. Clinical trials for patients with Type 2 Diabetes have shown that the oral semaglutide co-formulated with 300 mg SNAC could be used for further clinical development.
Status:
Possibly Marketed Outside US
First approved in 2017
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Trimethylamine (or TMA) a tertiary amine, is synthesized by the action of microbial enzymes in humans. The decrease of TMA metabolism and excessive TMA excretion cause the disease trimethylaminuria and some other diseases associated with the abnormal level of TMA, e.g., obesity, diabetes, cardiovascular diseases. It was shown, that TMS is a full agonist of human trace amine-associated receptor 5, TAAR5. In addition, TMA is a precursor of N-oxide form, an emergent biomarker of human health that can lead to renal diseases, neurological disorders, and cancer.
Status:
Possibly Marketed Outside US
Source:
XR CELLULAR MAGIC by MESO SYSTEM S.A.
(2016)
Source URL:
First approved in 2016
Source:
XR CELLULAR MAGIC by MESO SYSTEM S.A.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
DR. COLOR EFFECT RED by ES PURE VINE INC.
(2016)
Source URL:
First approved in 2016
Source:
DR. COLOR EFFECT RED by ES PURE VINE INC.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
First approved in 2016
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Uric acid, generated from the metabolism of purines, has proven and emerging roles in human disease. Humans produce large quantities of uric acid. Excess serum accumulation of uric acid can lead to a type of arthritis known as gout. Hyperuricemia may increase risk factors for cardiovascular disease. High serum uric acid was associated with higher risk of type 2 diabetes and other diseases.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2016)
Source URL:
First approved in 2016
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
D,L-Glutamic acid is a mixture of naturally occurring proteinogenic L-glutamic acid and non-proteinogenic D-glutamic acid. D,L-Glutamic acid is used to study mechanisms of crystal formation and self-assembly on surfaces and copolymer development. D-Glutamic acid is a component of bacterial peptidoglycans, produced by glutamate racemase.
Status:
Possibly Marketed Outside US
First approved in 2016
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Uric acid, generated from the metabolism of purines, has proven and emerging roles in human disease. Humans produce large quantities of uric acid. Excess serum accumulation of uric acid can lead to a type of arthritis known as gout. Hyperuricemia may increase risk factors for cardiovascular disease. High serum uric acid was associated with higher risk of type 2 diabetes and other diseases.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2016)
Source URL:
First approved in 2016
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
D,L-Glutamic acid is a mixture of naturally occurring proteinogenic L-glutamic acid and non-proteinogenic D-glutamic acid. D,L-Glutamic acid is used to study mechanisms of crystal formation and self-assembly on surfaces and copolymer development. D-Glutamic acid is a component of bacterial peptidoglycans, produced by glutamate racemase.
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)
