RODRIGO SOUZA

Biocatalysis and Organic Synthesis Group, Chemistry Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil

Seladelpar, marketed under the brand name Livdelzi, is a medication recently approved by the FDA on August 14, 2024, for the treatment of primary biliary cholangitis (PBC). This approval is based on the lysine dihydrate salt form of seladelpar, offering new therapeutic options for patients suffering from this chronic liver disease. Primary biliary cholangitis is a progressive autoimmune condition where the bile ducts within the liver become inflamed, damaged, and ultimately destroyed, leading to severe liver dysfunction. By targeting the peroxisome proliferator-activated receptor delta (PPARδ), a nuclear receptor involved in lipid and glucose metabolism and present in various liver cell types, seladelpar modulates inflammatory responses and reduces bile production. CymaBay Therapeutics, the developer of seladelpar, claims that this mechanism helps decrease the bile’s toxic impact on liver cells, thereby alleviating symptoms and slowing the disease’s progression.

Originally developed by Janssen Pharmaceuticals, seladelpar was licensed to CymaBay Therapeutics in 2006, with the company later positioning it for FDA approval specifically to address PBC. Re ...