Elafibranor is a dual PPARα/δ agonist.[5][6] 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.[1]
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.[1]
In June 2024, the US FDA granted accelerated approval to elafibranor. The approval was based on positive phase III ELATIVE trial data.[10] The designation was granted to Ipsen.[11]
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Legal status
In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Iqirvo, intended for the treatment of primary biliary cholangitis (PBC).[12] The applicant for this medicinal product is Ipsen Pharma.[12]
^World Health Organization (2015). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 74". WHO Drug Information. 29 (3). hdl:10665/331070.
^ ab"Iqirvo EPAR". European Medicines Agency. 25 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Cariou B, Staels B (October 2014). "GFT505 for the treatment of nonalcoholic steatohepatitis and type 2 diabetes". Expert Opinion on Investigational Drugs. 23 (10): 1441–8. doi:10.1517/13543784.2014.954034. PMID25164277. S2CID3190253.