Seladelpar: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Seladelpar. Educational only — not medical advice.

Labeled uses

LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) [see Clinical Studies (14) ] . Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Source: FDA labeling via NIH DailyMed (set 89f79d98…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.