 | |
| Clinical data | |
|---|---|
| Trade names | Iqirvo |
| Other names | GFT505, SureCN815512 |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | By mouth |
| Drug class | Antihyperlipidemic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number | |
| PubChemCID | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| PDB ligand | |
| CompTox Dashboard(EPA) | |
| Chemical and physical data | |
| Formula | C22H24O4S |
| Molar mass | 384.49 g·mol−1 |
| 3D model (JSmol) | |
| |
| |
Elafibranor (INN[5]), sold under the brand nameIqirvo, is amedication used for the treatment ofprimary biliary cholangitis.[1][6]
Elafibranor is a dualPPARα/δ agonist.[7][8] 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]
In June 2024, the USFood and Drug Administration (FDA) granted accelerated approval to elafibranor.[1][9][6][10] The FDA considers it to be afirst-in-class medication.[11]
Elafibranor isindicated for the treatment ofprimary biliary cholangitis in combination withursodeoxycholic acid in adults who have an inadequate response to ursodeoxycholic acid, or as monotherapy in people unable to tolerate ursodeoxycholic acid.[1][6][12]
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 2019, the USFood and Drug Administration (FDA) granted elafibranorbreakthrough therapy designation, based on phase II data, for the treatment ofprimary biliary cholangitis in adults 18 and older with inadequate response toursodeoxycholic acid (UDCA).[13] The designation was granted to Genfit.[13]
In June 2024, the US FDA granted accelerated approval to elafibranor. The approval was based on positive phase III ELATIVE trial data.[14] The designation was granted toIpsen.[15]
In July 2024, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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).[2] The applicant for this medicinal product is Ipsen Pharma.[2] Elafibranor was authorized for medical use in the European Union in September 2024.[2][3]
In October 2024, theNational Institute for Health and Care Excellence (NICE) adopted a recommendation for elafibranor for the treatment of adults with theprimary biliary cholangitis based results from the phase 3 ELATIVE trial, in which 51% of patients receiving elafibranor in combination withursodeoxycholic acid achieved a cholestasis response at week 52, compared to 4% of those in the placebo plus ursodeoxycholic acid group.[16][17]
Thischemical compound is also being studied and developed by Genfit for the treatment of endocrine and metabolic diseases such astype 2 diabetes,dyslipidemia, andMASH.[18][19][20]
