4.5 Review

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

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Article Biochemistry & Molecular Biology

Selective PPARδ agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 via the fibroblast growth factor 21 signaling pathway

Tetsuya Kouno et al.

Summary: The study demonstrates that the PPAR delta agonist seladelpar reduces bile acid synthesis by inhibiting Cyp7a1 and regulating Fgf21.

JOURNAL OF BIOLOGICAL CHEMISTRY (2022)

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Seladelpar improved measures of pruritus, sleep, and fatigue and decreased serum bile acids in patients with primary biliary cholangitis

Andreas E. Kremer et al.

Summary: The study found that seladelpar treatment for 1 year in PBC patients led to significant improvement in itching symptoms, quality of life, and biochemical markers. This suggests that seladelpar has the potential to address key unmet needs in PBC patients as a single agent.

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A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis

Christopher L. Bowlus et al.

Summary: This study examined the efficacy and safety of seladelpar in patients with primary biliary cholangitis (PBC). The results showed that seladelpar significantly improved biochemical markers of cholestasis and inflammation, and the improvements were maintained or improved after dose escalation at 52 weeks. The treatment was safe and not associated with worsening pruritus.

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