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Search results for uridine root_notes_note in Note (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 2015
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Status:
US Approved Rx
(2014)
Source:
BLA125390
(2014)
Source URL:
First approved in 2014
Source:
BLA125390
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2012)
Source:
NDA203441
(2012)
Source URL:
First approved in 2012
Source:
NDA203441
Source URL:
Class:
PROTEIN
Conditions:
Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. It is made up of 33 amino acids and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. Teduglutide differs from GLP-2 by one amino acid (alanine is substituted by glycine). The significance of this substitution is that teduglutide is longer acting than endogenous GLP-2 as it is more resistant to proteolysis from dipeptidyl peptidase-4. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). FDA approved on December 21, 2012. In Europe it has been granted orphan drug status and is marketed under the brand Revestive by Nycomed. It works by promoting mucosal growth and possibly restoring gastric emptying and secretion.
Status:
Investigational
Source:
INN:pitozinameran [INN]
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
INN:ganulameran [INN]
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Source:
BLA125742
(2021)
Source URL:
First approved in 2021
Source:
BLA125742
Source URL:
Class:
NUCLEIC ACID