seladelpar for previously treated primary biliary cholangitis

Seladelpar is an oral, once‐daily medication that improves cholestasis through its selective peroxisome proliferator‐activated receptor (PPAR‐δ) agonism (1):

• decreases bile acid transport in the cholangiocytes and downregulates cholesterol synthesis, a substrate for bile acid
• also has anti‐fibrotic and anti‐inflammatory action through Kupffer's and stellate cells

NICE state that (2):

Seladelpar can be used, within its marketing authorisation, as an option to treat primary biliary cholangitis, including associated pruritus, in adults. It can be used:

• with ursodeoxycholic acid (UDCA), if UDCA alone has not worked well enough, or
• alone, if UDCA cannot be tolerated

The NICE committee note:

“..Clinical trial evidence shows that seladelpar improves indicators of liver function, such as alkaline phosphatase (ALP), more than placebo. This suggests that seladelpar could delay the condition getting worse. The evidence also shows that seladelpar reduces pruritus (itch) compared with placebo…Seladelpar has not been directly compared in a clinical trial with obeticholic acid or elafibranor. But the results of indirect comparisons suggest that seladelpar may reduce itch more than obeticholic acid. And it may improve ALP-related outcomes more than obeticholic acid or elafibranor..”

Reference:

1. Abuelazm M, Alsakarneh S, Tanashat M, Manasrah A, Ibrahim AA, Parajuli S, Eltaly H, Amin AM. The Efficacy and Safety of Seladelpar for Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis. JGH Open. 2025 Aug 28;9(9):e70265.