Lumena announced that the FDA has granted Orphan Drug designation to LUM001 in four rare cholestatic liver diseases: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC). LUM001 is an inhibitor of the apical sodium-dependent bile acid transporter (ASBT), which recycles intestinal bile acids back into the circulation.

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LUM001 has been studied in more than 1,400 patients in 12 different clinical studies. Lumena plans on conducting four separate Phase 2 studies of LUM001 in children with ALGS, in adult patients with PBC, in pediatric patients with PFIC, and in adults with PSC.

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