Elafibranor

Elafibranor (INN ), sold under the brand name Iqirvo, is a medication used for the treatement of primary biliary cholangitis.

Elafibranor is a dual PPARα/δ agonist. Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPAR-alpha, PPAR-gamma, and PPAR-delta in vitro.

In June 2024, the US Food and Drug Administration (FDA) granted accelerated approval to elafibranor.

Medical uses
Elafibranor is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to ursodeoxycholic acid, or as monotherapy in people unable to tolerate ursodeoxycholic acid.

Adverse effects
The most common adverse reactions include weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.

History
In 2019, the US Food and Drug Administration (FDA) granted elafibranor breakthrough therapy designation, based on phase II data, for the treatment of primary biliary cholangitis in adults 18 and older with inadequate response to ursodeoxycholic acid (UDCA). The designation was granted to Genfit.

In June 2024, the US FDA granted accelerated approval to elafibranor. The approval was based on positive phase III ELATIVE trial data. The designation was granted to Ipsen.

Research
This chemical compound is also being studied and developed by Genfit for the treatment of endocrine and metabolic diseases such as type 2 diabetes, dyslipidemia, and MASH.