Primary biliary cholangitis (PBC)

Active Ingredient: Seladelpar

Indication for Seladelpar

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Seladelpar is indicated for the treatment of 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.

For this indication, competent medicine agencies globally authorize below treatments:

10 mg once daily

For:

Dosage regimens

Oral, 10 milligrams seladelpar, once daily.

Detailed description

The recommended dose of seladelpar is 10 mg once daily.

Missed dose

If a dose of seladelpar is missed, the patient should take the subsequent dose at the next scheduled time point. A double dose should not be taken to make up for the missed dose.

Active ingredient

Seladelpar

Seladelpar is a peroxisome proliferator-activated receptor delta (PPARδ) agonist, or delpar. 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. These actions result in lower bile acid exposure in the liver and reduced circulating bile acid levels.

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