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.
