Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study.
Gideon M HirschfieldMitchell L ShiffmanAliya F GulamhuseinKris V KowdleyJohn M VierlingCynthia LevyAndreas E KremerEhud ZigmondPietro AndreoneStuart C GordonChristopher L BowlusEric J LawitzRichard J AspinallDaniel S PrattKarina RaikhelsonMaria S Gonzalez-HuezoMichael A HeneghanSook-Hyang JeongAlma L Ladrón de GuevaraMarlyn J MayoGeorgios N DalekosJoost Paulus Hubertus DrenthEwa JanczewskaBarbara A LeggettFrederik NevensVíctor VargasEli ZuckermanChristophe CorpechotEduardo FassioHolger HinrichsenInvernizzi PietroPalak J TrivediLisa FormanDavid E J JonesStephen D RyderMark G SwainAlexandra SteinbergPol F BoudesYun-Jung ChoiCharles A McWherternull nullPublished in: Hepatology (Baltimore, Md.) (2023)
Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.