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Search results for glecaprevir in Related Substance Name (approximate match)
Status:
Possibly Marketed Outside US
Source:
NCT02710747: Phase 4 Interventional Unknown status Heart Valve Disease
(2015)
Source URL:
Class:
PROTEIN
Status:
Other
Class:
STRUCTURALLY DIVERSE
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.