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Restrict the search for
glecaprevir
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There is one exact (name or code) match for glecaprevir
Status:
US Approved Rx
(2021)
Source:
NDA215110
(2021)
Source URL:
First approved in 2017
Source:
NDA209394
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. In combination with Pibrentasvir, glecaprevir is a useful therapy for patients who experienced therapeutic failure from other NS3/4A protease inhibitors. It demonstrates a high genetic barrier against resistance mutations of the virus. Glecaprevir is available as an oral combination therapy with Pibrentasvir under the brand name Mavyret. On 3 August 2017 the FDA approved the combination for hepatitis C treatment. Mavyret is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV)
genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh
A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1
infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor
or an NS3/4A protease inhibitor (PI), but not both.
Status:
US Approved Rx
(2021)
Source:
NDA215110
(2021)
Source URL:
First approved in 2017
Source:
NDA209394
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. In combination with Pibrentasvir, glecaprevir is a useful therapy for patients who experienced therapeutic failure from other NS3/4A protease inhibitors. It demonstrates a high genetic barrier against resistance mutations of the virus. Glecaprevir is available as an oral combination therapy with Pibrentasvir under the brand name Mavyret. On 3 August 2017 the FDA approved the combination for hepatitis C treatment. Mavyret is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV)
genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh
A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1
infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor
or an NS3/4A protease inhibitor (PI), but not both.
Status:
US Approved Rx
(2017)
Source:
NDA209394
(2017)
Source URL:
First approved in 2017
Source:
NDA209394
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Pibrentasvir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS5A inhibitor that targets the the viral RNA replication and viron assembly. NS5A is a phosphoprotein that plays an essential role in replication, assembly and maturation of infectious viral proteins. The basal phosphorylated form of NS5A, which is maintained by C-terminal serine cluster, is key in ensuring its interaction with the viral capsid protein, or the core protein. By blocking this interaction, pibrentasvir inhibits the assembly of proteins and production of mature HCV particles. In the United States and Europe, Pibrentasvir is approved for use with glecaprevir as the combination drug glecaprevir/pibrentasvir (trade name Mavyret in the US and Maviret in the EU) for the treatment of hepatitis C. This fixed-dose combination therapy was FDA-approved in August 2017 to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.
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:
NCT03534063: Not Applicable Interventional Completed Pain, Postoperative
(2018)
Source URL:
Class:
PROTEIN
