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Showing 1 - 5 of 5 results
Status:
US Approved Rx
(2017)
Source:
NDA209803
(2017)
Source URL:
First approved in 2017
Source:
NDA209803
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Ertugliflozin (PF-04971729) is a potent and selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor incorporating a unique dioxa-bicyclo[3.2.1]octane (bridged ketal) ring system. SGLT2 has become an important therapeutic target and several SGLT2-selective inhibitors are either approved or in clinical development for the management of blood glucose in patients with type 2 diabetes. Ertugliflozin demonstrated robust urinary glucose excretion in rats and an excellent preclinical safety profile. It was announced that FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes.
Status:
Possibly Marketed Outside US
Source:
Sulfasalazine-EH by Speroni, G.|Barchielli, R.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Sulfacarbamide is an antimicrobial agent that has been investigated as a therapeutic biochemical for diabetes treatment. Sulfacaramide - has a bacteriostatic effect due to competitive antagonism with PABA, preventing its inclusion in Dihydrofolic acid, which leads to a violation of the synthesis of tetrahydrofolic acid. Thus, the synthesis of nucleic acids is broken, as a result of which the growth and multiplication of microorganisms are suppressed.
Status:
US Approved Rx
(2010)
Source:
NDA022341
(2010)
Source URL:
First approved in 2010
Source:
NDA022341
Source URL:
Class:
PROTEIN
Conditions:
Liraglutide is an acylated human Glucagon-Like Peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). GLP-1(7-37) represents <20% of total circulating endogenous GLP-1. Like GLP-1(7-37), liraglutide activates the GLP-1 receptor, a membranebound cell-surface receptor coupled to adenylyl cyclase by the stimulatory G-protein, Gs, in pancreatic beta cells. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a
glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying. GLP-1(7-37) has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase IV (DPP-IV) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration, is a result of self-association that delays absorption, plasma protein binding and stability against metabolic degradation by DPP-IV and NEP. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for weight loss. Liraglutide helps to induce and sustain weight loss in patients with obesity. Its efficacy is comparable to other available agents but it offers the unique benefit of improved glycemic control.
Status:
US Approved Rx
(2016)
Source:
BLA208673
(2016)
Source URL:
First approved in 2000
Source:
BLA021081
Source URL:
Class:
PROTEIN
Targets:
Insulin glargine, a long-acting form of insulin, was marketed under the brand name LANTUS. Lantus is indicated for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. The primary activity of insulin glargine is regulation of glucose metabolism. It lowers blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. The off-label use of insulin glargine is the treatment type 2 diabetes in children and the treatment of gestational diabetes.
Status:
US Approved Rx
(2017)
Source:
NDA209803
(2017)
Source URL:
First approved in 2017
Source:
NDA209803
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Ertugliflozin (PF-04971729) is a potent and selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor incorporating a unique dioxa-bicyclo[3.2.1]octane (bridged ketal) ring system. SGLT2 has become an important therapeutic target and several SGLT2-selective inhibitors are either approved or in clinical development for the management of blood glucose in patients with type 2 diabetes. Ertugliflozin demonstrated robust urinary glucose excretion in rats and an excellent preclinical safety profile. It was announced that FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes.