Shots:
The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada
NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…
Shots:
At this year’s European Association for the Study of the Liver (EASL) Congress in Amsterdam, Gilead shared new data and 29 abstracts, including three oral presentations. But the data wasn’t the only thing that got people talking about Gilead’s commitment to transforming the lives of people living with liver conditions
EASL saw the launch…
Shots:
The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026)
NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial
Trial…
Shots:
GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial
Trial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…
Shots:
Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoing
Trial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectively
Elafibranor…

