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Fenofibrate + ursodeoxycholic acid is a combination therapy consisting of two small molecule drugs—fenofibrate, a peroxisome proliferator-activated receptor alpha (PPARα) agonist primarily used for dyslipidemia, and ursodeoxycholic acid (UDCA), a bile acid used as first-line treatment for primary biliary cholangitis (PBC). This combination is primarily investigated in patients with PBC who have an incomplete biochemical response to UDCA monotherapy. Fenofibrate acts by activating PPARα to increase lipolysis, reduce triglycerides, and exert anti-inflammatory effects; UDCA improves bile flow and reduces toxic bile acids. Clinical studies and meta-analyses show that the combination improves liver biochemistry markers such as alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), immunoglobulin M (IgM), and triglycerides more effectively than UDCA alone in both treatment-naive patients and those refractory to UDCA[1][2][6][10]. The safety profile is generally acceptable but may include increased risk of adverse events such as abdominal pain or myalgias; caution is advised in cirrhotic patients[1][2]. The combination has not been approved as a fixed-dose product but is widely studied off-label.
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