Brand Name
Livdelzi
Generic Name
Seladelpar
View Brand Information FDA approval date: August 14, 2024
Form: Capsule
What is Livdelzi (Seladelpar)?
LIVDELZI is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid 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 . 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. LIVDELZI is a peroxisome proliferator-activated receptor -delta agonist indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have 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 . 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. Limitations of Use Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis .
Approved To Treat
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Related Clinical Trials
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.


