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Data from Phase 1 and Phase 2 clinical trials of volixibat demonstrated decreases in LDL cholesterol, increases in C4 and increases in fecal bile acid content, all markers of ASBT inhibition. Safety, tolerability and efficacy of volixibat, an apical sodium-dependent bile acid transporter inhibitor, in adults with non-alcoholic steatohepatitis: week interim analysis results from a phase 2 study. This leads to improvements in liver function, pruritus and other symptoms of cholestatic liver diseases. Increases fecal bile acid excretion. Safety and efficacy of maralixibat in patients with primary sclerosing cholangitis: an open-label proof-of-concept study. We believe that volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking recycling of bile acids, thereby reducing bile acids systemically. Phase 2 open-label efficacy and safety study of the apical sodium-dependent bile acid transporter inhibitor maralixibat in children with progressive familial intrahepatic cholestasis: week interim efficacy analysis. In the Phase 2 INDIGO clinical trial of maralixibat, children with PFIC2 experienced a multi-parameter response, including reduced pruritus, reductions in serum bile acids, normalization of liver enzymes and improved quality of life scores.

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    Volixibat is an oral, minimally-absorbed investigational therapy designed to selectively inhibit ASBT, a protein that is primarily responsible for recycling bile acids from the intestine to the liver.

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    Biliary Atresia BA. Genotype and dose-dependent response to maralixibat in patients with bile salt export pump deficiency Richard Thompson View Publication Durability of Treatment Effect with Long-Term Maralixibat in Children with Alagille Syndrome: 4-Year Safety and Efficacy Emmanuel Gonzales View Publication Safety and efficacy of maralixibat in patients with primary sclerosing cholangitis: an open-label proof-of-concept study View Publication Dose-dependent fecal bile acid excretion with apical sodium-dependent bile acid transporter inhibitors maralixibat and volixibat in a dose-ranging phase 1 study in overweight and obese adults View Publication Phase 2 placebo-controlled withdrawal study of the ASBT inhibitor maralixibat in children with Alagille syndrome Gonzales, E et al.

    Phase 2 open-label efficacy and safety study of the apical sodium-dependent bile acid transporter inhibitor maralixibat in children with progressive familial intrahepatic cholestasis: week interim efficacy analysis. A long-term phase 2 safety and efficacy study of the apical sodium-dependent bile acid transporter inhibitor maralixibat in children with Alagille syndrome: preliminary results from the IMAGINE study.

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    Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses.

    ASBT is present in the small intestine and mediates the uptake of bile acids in the intestines, recycling them back to the liver.

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    Increases fecal bile acid excretion. We believe that volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking recycling of bile acids, thereby reducing bile acids systemically.

    PRO Validation. At the week measurement, pruritus and serum bile acid reductions were maintained and improvements in xanthomas disfiguring and often debilitating buildup of lipid deposits and quality of life were also observed.

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    Contact Us. This leads to liver injury, progressive liver disease and, if left untreated, can result in fibrosis, cirrhosis, liver failure and death.

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    Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. We believe that volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking recycling of bile acids, thereby reducing bile acids systemically.

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    View Publication. Progressive familial intrahepatic cholestasis Davit-Spraul, A et al. At the week measurement, pruritus and serum bile acid reductions were maintained and improvements in xanthomas disfiguring and often debilitating buildup of lipid deposits and quality of life were also observed.

    images stock ticker lookup apical
    Stock ticker lookup apical
    The FDA has granted maralixibat breakthrough therapy designation for pruritus associated with Alagille syndrome in patients one year of age and older.

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    Alagille syndrome: pathogenesis, diagnosis and management, European Journal of Human Genetics. ASBT Inhibition. Patients with cholestatic liver disease typically experience debilitating itching prurituswhich dramatically impacts quality of life and can lead to scarring, sleep deprivation, significant fatigue and psycho-social effects. At the week measurement, pruritus and serum bile acid reductions were maintained and improvements in xanthomas disfiguring and often debilitating buildup of lipid deposits and quality of life were also observed.

    ASBT inhibition results in more bile acids being excreted in the feces, leading to lower levels of bile acids systemically, thereby reducing bile acid mediated liver damage. We believe that volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking recycling of bile acids, thereby reducing bile acids systemically.

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    1. The FDA has granted maralixibat breakthrough therapy designation for pruritus associated with Alagille syndrome in patients one year of age and older. In the Phase 2 INDIGO clinical trial of maralixibat, children with PFIC2 experienced a multi-parameter response, including reduced pruritus, reductions in serum bile acids, normalization of liver enzymes and improved quality of life scores.