LIVDELZI

What it is

LIVDELZI contains seladelpar. Each capsule contains 14.1 mg seladelpar lysine dihydrate equivalent to 10 mg seladelpar. Seladelpar is a peroxisome proliferator-activated receptor (PPARδ) agonist. PPARδ is a nuclear receptor expressed in the liver and other tissues. PPARδ activation reduces bile acid synthesis in the liver through Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol, and by decreasing cholesterol synthesis and absorption.

Approved indications

— Primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.

Dosing overview

The recommended dosage of LIVDELZI is 10 mg taken orally once daily with or without food.

Key safety warnings

LIVDELZI has been associated with dose-related increases in serum transaminase levels greater than 3-times the upper limit of normal in PBC patients receiving higher doses (5-times and 20-times the recommended dosage). Transaminase levels returned to pretreatment levels upon LIVDELZI discontinuation. LIVDELZI 10 mg once daily did not show a similar pattern for increases in transaminase levels. Obtain baseline clinical and laboratory assessments at treatment initiation with LIVDELZI and monitor thereafter according to routine patient management. Interrupt LIVDELZI treatment if the liver tests worsen, or the patient develops signs and symptoms consistent with liver dysfunction. Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Dose dependent increases in serum creatinine have been observed in LIVDELZI-treated patients. In clinical trials, median increases of up to 6.6% were observed with the 10 mg dose. Increases were not progressive and returned towards baseline with ongoing LIVDELZI treatment. None of the patients required discontinuation of LIVDELZI and there were no clinical findings associated with the observed changes in serum creatinine.

Contraindications

LIVDELZI is contraindicated in patients with known hypersensitivity to seladelpar or any of the excipients.

PBS listing

PBAC recommended PBS listing for the treatment of PBC in patients with inadequate response to or intolerance of ursodeoxycholic acid (UDCA).

Regulatory history

LIVDELZI seladelpar 10 mg capsule was first listed on the ARTG on 28 January 2026. In July 2025, the PBAC deferred the application pending TGA advice. In December 2025, the PBAC recommended PBS listing for the treatment of PBC in patients with inadequate response to or intolerance of ursodeoxycholic acid, noting it was as effective as obeticholic acid with improved itching symptoms.