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Iqirvo (ELAFIBRANOR)

Ipsen · FDA-approved approved Small molecule Quality 60/100

Iqirvo works by activating peroxisome proliferator-activated receptors to improve liver function.

Iqirvo (elafibranor) is a small molecule peroxisome proliferator-activated receptor agonist developed by Ipsen. It is approved for the treatment of primary biliary cholangitis (PBC) and decompensated cirrhosis. Iqirvo works by activating specific receptors in the body to improve liver function. It has a long half-life of 70.2 hours and is patented, with no generic manufacturers available. Iqirvo was FDA-approved in 2024.

At a glance

Generic nameELAFIBRANOR
SponsorIpsen
Drug classPeroxisome Proliferator-activated Receptor Agonist [EPC]
ModalitySmall molecule
Therapeutic areaMetabolic
PhaseFDA-approved
First approval2024

Mechanism of action

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. However, the mechanism by which elafibranor exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPAR-alpha and PPAR-delta. The signaling pathway for PPAR-delta was reported to include Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol. An in vitro PPAR functional assay showed that both elafibranor and GFT1007 produced activation of PPAR-alpha (EC 50 = 46 nM and 14 nM, respectively, and E max = 56% and 61%, respectively, relative to reference agonists). The potency of elafibranor and GFT1007 for PPAR-alpha activation exceeded the re

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Patents

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Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity

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