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Search results for l root_names_stdName in Standardized Name (approximate match)
Status:
US Approved Rx
(2012)
Source:
NDA202811
(2012)
Source URL:
First approved in 2012
Source:
NDA202811
Source URL:
Class:
PROTEIN
Conditions:
Linaclotide (marketed under the trade name Linzess and Constella) is a peptide agonist of the guanylate cyclase 2C (GC-C). Once linaclotide and its active metabolite binds to GC-C, it has local effect on the luminal surface of the intestinal epithelium. Activation of GC-C by linaclotide results in the intra- and extracellular increase of cyclic guanosine monophosphate concentrations (cGMP). This elevation of cGMP levels stimulates the secretion of chloride and bicarbonate into the intestinal lumen via activation of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel. The metabolite of linaclotide MM-419447 (CCEYCCNPACTGC) contributes to the pharmacologic effects of linaclotide. Ultimately, linaclotide helps patients with IBS (especially with constipation) as GI transit is accelerated and the release of intestinal fluid is increased. In animal models, a decrease in visceral pain after administration of linaclotide may be observed. A decrease in the activity of pain-sensing nerves occurs as a result of an increase in extracellular cGMP. It was approved by the FDA in August 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
Status:
US Approved Rx
(2007)
Source:
NDA022074
(2007)
Source URL:
First approved in 2007
Source:
NDA022074
Source URL:
Class:
PROTEIN
Conditions:
Lanreotide is a medication used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably carcinoid syndrome. It is a long-acting analog of somatostatin. It is available in several countries, including the United Kingdom, Australia and Canada, and was approved for sale in the United States by the Food and Drug Administration on August 30, 2007. Lanreotide was developed in the lab of Dr. David H. Coy, School of Medicine. Dr. Coy serves as Director of the Peptide Laboratory. Lanreotide (as lanreotide acetate) is manufactured by Ipsen, and marketed under the trade name Somatuline. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin. Lanreotide has a high affinity for human somatostatin receptors (SSTR) 2 and 5 and a reduced binding affinity for human SSTR1, 3, and 4. Activity at human SSTR 2 and 5 is the primary mechanism believed responsible for GH inhibition. Like somatostatin, lanreotide is an inhibitor of various endocrine, neuroendocrine, exocrine and paracrine functions. Lanreotide inhibits the basal secretion of motilin, gastric inhibitory peptide and pancreatic polypeptide, but has no significant effect on the secretion of secretin. Lanreotide inhibits postprandial secretion of pancreatic polypeptide, gastrin and cholecystokinin (CCK). In healthy subjects, lanreotide produces a reduction and a delay in post-prandial insulin secretion, resulting in transient, mild glucose intolerance.
Status:
US Approved Rx
(2005)
Source:
NDA021332
(2005)
Source URL:
First approved in 2005
Source:
NDA021332
Source URL:
Class:
PROTEIN
Conditions:
Pramlintide is an analog of human amylin. Amylin is co-secreted with insulin from pancreatic beta cells and acts centrally to slow gastric emptying, suppress postprandial glucagon secretion, and decrease food intake. These actions complement those of insulin to regulate blood glucose concentrations. Amylin is relatively deficient in patients with type 2 diabetes, depending on the severity of beta-cell secretory failure, and is essentially absent in patients with type 1 diabetes. Through mechanisms similar to those of amylin, pramlintide improves overall glycemic control, reduces postprandial glucose levels, and reduces bodyweight in patients with diabetes using mealtime insulin. SYMLIN® (pramlintide acetate) is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.
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
(2001)
Source:
NDA021288
(2001)
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:
NDA211215
(2019)
Source URL:
First approved in 2000
Source:
NDA020873
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Bivalirudin is a synthetic 20 amino acid peptide rationally designed based on structural studies of hirudin, a naturally occurring anticoagulant. Bivalirudin is sold under the brand name Angiomax and is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). It is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. Bivalirudin directly inhibits thrombin by binding simultaneously to its active catalytic site and its substrate recognition site.
Status:
US Approved Rx
(1982)
Source:
NDA017707
(1982)
Source URL:
First approved in 1982
Source:
NDA017707
Source URL:
Class:
PROTEIN
Conditions:
Indium In-111 pentetate disodium is a radioactive diagnostic indicated for use in radionuclide cisternography. Decay of In-111 by electron capture allows for detection with a gamma camera for visualization of the brain and spinal column. Indium In 111 pentetate ( 111In-DTPA) is indicated as an imaging agent in cisternography to study the flow of cerebrospinal fluid (CSF) in the brain, to diagnose abnormalities in CSF circulation, to assess and help localize the site of CSF leakage, and to test the patency of or localize blocks in CSF shunts.
Status:
Investigational
Source:
NCT01479244: Phase 3 Interventional Completed Breast Cancer With Low to Intermediate HER2 Expression
(2011)
Source URL:
Class:
PROTEIN
Nelipepimut-S (formerly known as E75) is an immunogenic peptide from the HER2 protein that is highly expressed in breast cancer. The NeuVax™ (Galena, OR, USA) vaccine, nelipepimut-S plus granulocyte-macrophage colony-stimulating factor, is designed for the prevention of clinical recurrences in high risk, disease-free breast cancer patients. Nelipepimut-S is being developed by Sellas Life Sciences Group. When combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF), nelipepimut-S has been used as a vaccine that is capable of eliciting a robust anti-HER2 immune response. Early-phase clinical trials that enrolled women with node-positive or high-risk node-negative breast cancer who had been rendered disease free with standard of care therapy but were at risk for recurrence, demonstrated the vaccine to be safe with a suggestion of clinical benefit. Nelipepimut-S is currently being evaluated in a Phase III clinical trial.
Status:
Investigational
Class:
PROTEIN
Status:
Investigational
Source:
INN:getacatetide [INN]
Source URL:
Class:
PROTEIN