Seladelpar, a new therapy for treating primary biliary cholangitis (PBC), appears to be effective in improving key liver function parameters and has an acceptable safety profile, according to a study recently published in BMC Gastroenterology.
PBC is a liver disease characterized by the progressive destruction of the liver bile ducts, which eventually leads to liver fibrosis and failure. Approximately 90% of cases involve middle-aged women, and the prevalence of this disorder is rising across both North America and Europe.
Seladelpar is a relatively new therapy for PBC and has already demonstrated efficacy in improving the symptoms most commonly associated with this disorder, such as pruritus (itching), fatigue and sleep disturbances. However, further studies are necessary to gain a more complete picture of its efficacy and safety profile.
Researchers thus conducted a study to better evaluate this new treatment. They looked into existing studies (until March 2025) regarding the drug by combing through academic search engines. After a rigorous screening process, they included a total of three studies comprising 496 patients in their systemic review.
Read more about PBC signs and symptoms
An analysis of these three studies showed that seladelpar was associated with the increased normalization of a key liver enzyme, alanine phosphatase (ALP), compared with the placebo. ALP normalization is an important indicator of the effectiveness of any therapy used to treat PBC. In addition, seldelpar was associated with the reduction in another key liver enzyme, alanine transferase (ALT), from initial assessment to follow-up.
Overall, researchers found that seladelpar was associated with a significant increase in biochemical response compared with the placebo, strengthening the case for its use. In terms of safety, researchers found that headaches and abdominal pain were more commonly reported among seladelpar users; however, other adverse events showed no significant difference between seladelpar users and those given the placebo.
“Seladelpar appears to be an effective treatment for PBC, demonstrating significant improvements in key liver function markers,” the study’s authors wrote. “While it has shown therapeutic benefits, further research is warranted to evaluate its long-term safety … and to determine its efficacy across different dosages.”
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