Seladelpar: First Approval.

Seladelpar (LIVDELZI®) is an oral delpar [i.e. a selective peroxisome proliferator-activated receptor (PPAR)δ agonist] being developed by Gilead Sciences for the treatment of primary biliary cholangitis (PBC). On 14 August 2024, based on a reduction in alkaline phosphatase (ALP), it received accelerated approval in the USA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. A regulatory assessment for seladelpar for the treatment of PBC is underway in the EU and the UK. This article summarizes the milestones in the development of seladelpar leading to this first approval.