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Search results for azelaic root_protein_modifications_structuralModifications_structuralModificationType in Protein Structural Modification Type (approximate match)
Status:
US Approved Rx
(2005)
Source:
BLA021878
(2005)
Source URL:
First approved in 2005
Source:
BLA021878
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Insulin detemir, a long-acting human insulin analog, is sold under the brand name LEVEMIR to improve glycemic control in adults and children with diabetes mellitus. Insulin detemir binds to the insulin receptor. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. The primary activity of insulin detemir is the regulation of glucose metabolism. Insulin detemir crosses the BBB and reduces food intake, it improves weight management by an enhanced and prolonged centrally mediated reduction of energy intake.
Status:
US Approved Rx
(2004)
Source:
NDA021256
(2004)
Source URL:
First approved in 2004
Source:
NDA021256
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Human secretin is a gastrointestinal peptide hormone that regulates secretions in the stomach, pancreas, and liver. Synthetic human secretin displays equivalent biological activity and properties as naturally occurring secretin. Acetate salt of synthetic secretin was marketed under the name ChiRhoStim. ChiRhoStim is indicated for the stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, for the gastrin secretion to aid in the diagnosis of gastrinoma. ChiRhoStim is also used for the pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic, retrograde cholangiopancreatography (ERCP). When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid.
Status:
US Approved Rx
(2004)
Source:
NDA021060
(2004)
Source URL:
First approved in 2004
Source:
NDA021060
Source URL:
Class:
PROTEIN
Conditions:
Ziconotide (PRIALT; SNX-111) is a neuroactive peptide, which was approved by FDA in 2004 for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. Ziconotide acts as a selective N-type voltage-gated calcium channel blocker, which leads to a blockade of excitatory neurotransmitter release from the primary afferent nerve terminals.
Status:
US Approved Rx
(2002)
Source:
NDA021209
(2002)
Source URL:
First approved in 2002
Source:
NDA021209
Source URL:
Class:
PROTEIN
Conditions:
Secretin porcine stimulates pancreatic and gastric secretions to aid in the diagnosis of pancreatic exocrine dysfunction and the diagnosis of gastrinoma. Porcine Secretin for Injection administered intravenously stimulates gastrin release in patients with gastrinoma whereas only small changes in serum gastrin concentrations occur in healthy subjects and patients with peptic ulcer disease. The primary action of secretin is to stimulate pancreatic ductal cells to secrete pancreas fluid in large volumes that contain bicarbonate. Secretin is a hormone that is normally released from the duodenum upon exposure of the proximal intestinal lumen to gastric acid, fatty acids, and amino acids. Secretin is released from enterochromaffin cells in the intestinal mucosa. Secretin receptors have been identified in the pancreas, stomach, liver, colon, brain and other tissues. When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich pancreatic fluid. Secretin may also work through vagal-vagal neural pathways since stimulation of the efferent vagus nerve stimulates bicarbonate secretion and atropine blocks secretin-stimulated pancreatic secretion.
Status:
US Approved Rx
(2002)
Source:
BLA103946
(2002)
Source URL:
First approved in 2002
Source:
BLA103946
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2001)
Source:
BLA103949
(2001)
Source URL:
First approved in 2001
Source:
BLA103949
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2000)
Source:
NDA020715
(2000)
Source URL:
First approved in 2000
Source:
NDA020715
Source URL:
Class:
PROTEIN
Conditions:
Triptorelin is a synthetic decapeptide agonist analog of luteinizing hormone releasing hormone (LHRH). It works by decreasing the production of certain hormones, which reduces testosterone levels in the body. Animal studies comparing triptorelin to native GnRH found that triptorelin had 13 fold higher releasing activity for luteinizing hormone, and 21-fold higher releasing activity for follicle-stimulating hormone. Triptorelin is indicated for the palliative treatment of advanced prostate cancer.
Status:
US Approved Rx
(2019)
Source:
BLA761100
(2019)
Source URL:
First approved in 1998
Source:
BLA103792
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1998)
Source:
BLA103764
(1998)
Source URL:
First approved in 1998
Source:
BLA103764
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2017)
Source:
BLA761064
(2017)
Source URL:
First approved in 1997
Source:
BLA103705
Source URL:
Class:
PROTEIN