Seladelpar: an investigational drug for the treatment of early-stage primary biliary cholangitis (PBC)

Introduction Generic fibrates are used off-label as add-in therapy for the management of primary biliary cholangitis (PBC) but with unproven long-term liver-related survival benefits. The recently developed fibrate, seladelpar, has shown promising results in clinical trials, but these outcomes have been previously marred by safety concerns. Areas covered We summarize existing treatment options in PBC and evaluate current trial data for seladelpar in relation to liver biochemistry, symptomology, and safety. Expert opinion Seladelpar leads to marked improvement in liver biochemistry and may improve symptoms. Safety concerns around liver toxicity appear to have been addressed. With likely increasing evidence compared to existing off-label fibrates, seladelpar has the potential as an attractive future second-line agent in PBC.

Automated summary

This article summarizes the use of generic fibrates as add-in therapy for PBC and evaluates the clinical trial data of seladelpar in terms of liver biochemistry, symptomology, and safety. Results show that seladelpar leads to marked improvement in liver biochemistry and symptoms, and safety concerns have been addressed. Compared to existing off-label fibrates, seladelpar has the potential to be an attractive second-line agent in PBC.