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Search results for m root_names_stdName in Standardized Name (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2017)
Source URL:
First approved in 2012
Source:
Zithranol by Elorac Inc.
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
M032
(2018)
Source URL:
First approved in 2008
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2018)
Source URL:
First approved in 1995
Source:
21 CFR 333E
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
Proactiv MD Ultra-Gentle Cleanser by Alchemee, LLC
(2024)
Source URL:
First approved in 1993
Source:
21 CFR 358H
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2001)
Source URL:
First approved in 1975
Source:
ANDA202985
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2022)
Source:
BLA761263
(2022)
Source URL:
First approved in 2022
Source:
BLA761263
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
NDA214231
(2021)
Source URL:
First approved in 2021
Source:
NDA214231
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Dasiglucagon (Zegalogue®) is an antihypoglycaemic agent being developed by Zealand Pharma for the treatment of hypoglycaemia, type 1 diabetes mellitus (T1DM) management and congenital hyperinsulinism. Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an
antihypoglycemic effect. In March 2021, dasiglucagon received its first approval in the USA for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes aged 6 years and above. Dasiglucagon, a glucagon analogue, is available as a single-dose autoinjector or prefilled syringe for subcutaneous injection.
Status:
US Approved Rx
(2021)
Source:
BLA761195
(2021)
Source URL:
First approved in 2021
Source:
BLA761195
Source URL:
Class:
PROTEIN
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
(2005)
Source:
BLA125118
(2005)
Source URL:
First approved in 2005
Source:
BLA125118
Source URL:
Class:
PROTEIN