- FDA approved linerixibat (Lynavoy) on 19 March 2026 for cholestatic pruritus in adults with PBC.
- GSK announced on 9 March a licence deal granting Alfasigma worldwide rights to develop, manufacture and commercialise linerixibat, subject to customary conditions including US HSR clearance.
- GLISTEN phase III (n=119 linerixibat, n=119 placebo) met primary and key secondary endpoints with rapid itch reduction by week 2 and sustained effect to 24 weeks (WI‑NRS LS mean difference −0.72, p=0.001; sleep interference p=0.024).
- Linerixibat is an IBAT inhibitor; common adverse events were diarrhoea (61%) and abdominal pain (18%), with treatment discontinuation due to diarrhoea 4% versus <1% for placebo.
FDA approval
On 19 March 2026 the US FDA approved Lynavoy (linerixibat) for treatment of cholestatic pruritus in adults with primary biliary cholangitis (PBC); it is the first medicine approved in the US for this indication.
Clinical evidence
The approval is based on the global GLISTEN phase III trial which met primary and key secondary endpoints, showing significant, rapid (week 2) and sustained (24 weeks) reductions in worst-itch NRS versus placebo (n=119 per arm; LS mean difference −0.72, p=0.001) and improved itch-related sleep interference (p=0.024).
Safety
Most common adverse events were diarrhoea (61%) and abdominal pain (18%); treatment discontinuations due to diarrhoea occurred in 4% of patients versus <1% for placebo; overall safety was consistent with the IBAT inhibition mechanism.
Regulatory and commercial status
Linerixibat has Orphan Drug Designation in the US, EU and Japan and priority review in China; marketing applications are ongoing in the EU, UK, Canada and China. GSK announced on 9 March a licence agreement granting Alfasigma worldwide exclusive rights to develop, manufacture and commercialise linerixibat, subject to customary closing conditions including US HSR clearance.
Disease context and mechanism
Cholestatic pruritus affects up to 89% of people with PBC and can be debilitating; linerixibat is an oral ileal bile acid transporter (IBAT) inhibitor that reduces bile acid reuptake and multiple mediators implicated in cholestatic itch.
