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Restrict the search for
tafamidis
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There is one exact (name or code) match for tafamidis
Status:
US Approved Rx
(2019)
Source:
NDA211996
(2019)
Source URL:
First approved in 2019
Source:
NDA211996
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Tafamidis meglumine (Vyndaqel®, Pfizer) is a novel, first-in-class drug for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP), a rare neurodegenerative disorder characterized by progressive sensory, motor and autonomic impairment that is ultimately fatal. Pathogenic mutations in the transthyretin (TTR) protein lead to destabilization of its tetrameric structure and subsequent formation of amyloid aggregates. Tafamidis is a small-molecule inhibitor that binds selectively to TTR in human plasma and kinetically stabilizes the tetrameric structure of both wild-type TTR and a number of different mutants. Clinical trials indicate that tafamidis slows disease progression in patients with TTR-FAP and reduces the burden of disease, demonstrating improvement in small and large nerve fiber function, modified body mass index and lower extremity neurological examination. Tafamidis meglumine has been launched for TTR FAP in the EU, Japan, Argentina, Malta and Mexico, and is preregistration in the US for this indication.
Status:
US Approved Rx
(2019)
Source:
NDA211996
(2019)
Source URL:
First approved in 2019
Source:
NDA211996
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Tafamidis meglumine (Vyndaqel®, Pfizer) is a novel, first-in-class drug for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP), a rare neurodegenerative disorder characterized by progressive sensory, motor and autonomic impairment that is ultimately fatal. Pathogenic mutations in the transthyretin (TTR) protein lead to destabilization of its tetrameric structure and subsequent formation of amyloid aggregates. Tafamidis is a small-molecule inhibitor that binds selectively to TTR in human plasma and kinetically stabilizes the tetrameric structure of both wild-type TTR and a number of different mutants. Clinical trials indicate that tafamidis slows disease progression in patients with TTR-FAP and reduces the burden of disease, demonstrating improvement in small and large nerve fiber function, modified body mass index and lower extremity neurological examination. Tafamidis meglumine has been launched for TTR FAP in the EU, Japan, Argentina, Malta and Mexico, and is preregistration in the US for this indication.
Status:
US Previously Marketed
Source:
ISOPAQUE 280 by GE HEALTHCARE
(1974)
Source URL:
First approved in 1974
Source:
ISOPAQUE 280 by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Meglumine (N-methyl-D-glucamine) is a poorly metabolized derivative of sorbitol that has regulatory acceptance as a benign excipient for drug formulation to increase aqueous solubility of lipophilic drugs and improve their absorption. In conjugated form meglumine is used as a contrast agent.
Status:
Possibly Marketed Outside US
Source:
Octaplasma by Octapharma Pharmazeutika Produktionsges M B H [Canada]
Source URL:
First approved in 2013
Source:
BLA125416
Source URL:
Class:
MIXTURE
Status:
Investigational
Source:
NCT03673657: Phase 2 Interventional Completed Local Advanced Non-small Cell Lung Cancer
(2018)
Source URL:
Class:
PROTEIN
Status:
Investigational
Source:
NCT03830736: Not Applicable Interventional Completed Postprandial Glucose Regulation
(2019)
Source URL:
Class:
PROTEIN