Elafibranor is a peroxisome proliferator-activated receptor (PPAR) agonist, which was first approved for marketing in the United States in 2024. As an innovative drug, it provides a new treatment option for patients with primary biliary cholangitis (PBC).

Indications of Elafibranor

Treatment of Primary Biliary Cholangitis (PBC)

The main indication of elafibranor is the treatment of primary biliary cholangitis (PBC) in adults.

It is used as monotherapy for adult PBC patients who cannot tolerate ursodeoxycholic acid (UDCA).

Dosage Form, Strength and Properties of Elafibranor

Dosage Form and Strength

Dosage Form: Film-coated tablets.

Strength: Each tablet contains 80 mg of elafibranor.

Description of Properties

Appearance: Round, orange film-coated tablets, engraved with "ELA80" on one side and blank on the other side.

Excipient Ingredients

Tablet Core: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.

Film Coating: Iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Physicochemical Characteristics

Chemical Name: 2-(2,6-Dimethyl-4-{3-[4-(methylthio)phenyl]-3-oxoprop-1-en-1-yl}phenoxy)-2-methylpropanoic acid.

Molecular Formula: C₂₂H₂₄O₄S

Molecular Weight: 384.49 g/mol

Solubility: Almost insoluble in aqueous media with pH ranging from 1.2 to 6.8; slightly soluble in aqueous media with pH 7.5; soluble in dichloromethane; freely soluble in dimethyl sulfoxide (DMSO); slightly soluble in 2-propanol and ethanol.

Storage Conditions of Elafibranor

Storage Requirements

Temperature Requirement: Store at room temperature between 15°C and 30°C (59°F and 86°F).

Packaging Requirement: Must be stored in the original packaging (bottles and cartons).

Environmental Requirement: Protect from light and moisture.

Precautions

Keep the medicine out of the reach of children.

Do not store the medicine in humid environments such as bathrooms or kitchens.

Do not freeze the medicine.