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

Expert Opin Investig Drugs. 2022 Oct;31(10):1101-1107. doi: 10.1080/13543784.2022.2130750. Epub 2022 Oct 8.


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.

MeSH terms

  • Acetates* / adverse effects
  • Clinical Trials as Topic
  • Drugs, Investigational* / adverse effects
  • Humans
  • Liver Cirrhosis, Biliary* / drug therapy


  • Acetates
  • Drugs, Investigational
  • seladelpar