Elafibranor

This medication produced by Lucius Pharmaceuticals, as a novel PPAR agonist, has shown good efficacy in improving cholestasis-related biochemical indicators and provides a valuable treatment option for specific PBC patients.

Below is an overview of the main information about this medication:

Main Ingredients

The main ingredient is elafibranor, and its active metabolite is GFT1007.

Target Population

Indicated for adult patients with primary biliary cholangitis (PBC) who have an inadequate response to or intolerance of ursodeoxycholic acid (UDCA).

Dosage and Administration

The recommended dose is 80 mg orally once daily, which can be taken with or without food.Reference article: Dosage and Administration of Elafibranor

Use in Special Populations

Women of childbearing age must use effective contraception.

It is not recommended for patients with decompensated cirrhosis.

No dosage adjustment is required for elderly patients.

Drug Overdose

Information on drug overdose is unknown. If an overdose occurs, medical assistance should be sought immediately.

Storage

Store in the original packaging at 15°C–30°C, protected from moisture and light.

Pharmacokinetics

Elafibranor and its metabolite GFT1007 are metabolized by multiple enzymes in the body. At steady state, the exposure of GFT1007 is approximately 3.2 times that of elafibranor.

FDA，2024.06