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

Abstract

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.

Keywords: PPAR; Primary biliary cholangitis; fatigue; fibrates; peroxisome proliferator-activated receptor agonists; pruritus; seladelpar.