Last update 01 Oct 2026

Elafibranor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Elafibranor (USAN), GFT-505, IQIRVO
+ [1]
Action
agonists
Mechanism
PPARα agonists(Peroxisome proliferator-activated receptor α agonists), PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists)
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Jun 2024),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC22H24O4S
InChIKeyAFLFKFHDSCQHOL-UHFFFAOYSA-N
CAS Registry824932-88-9

External Link

KEGGWikiATCDrug Bank
D11208Elafibranor-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Primary Biliary Cholangitis
United States
10 Jun 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cholangitis, SclerosingPhase 3
United States
14 May 2026
Cholangitis, SclerosingPhase 3
China
14 May 2026
Cholangitis, SclerosingPhase 3
Japan
14 May 2026
Cholangitis, SclerosingPhase 3
Argentina
14 May 2026
Cholangitis, SclerosingPhase 3
Australia
14 May 2026
Cholangitis, SclerosingPhase 3
Austria
14 May 2026
Cholangitis, SclerosingPhase 3
Belgium
14 May 2026
Cholangitis, SclerosingPhase 3
Brazil
14 May 2026
Cholangitis, SclerosingPhase 3
Canada
14 May 2026
Cholangitis, SclerosingPhase 3
Czechia
14 May 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
321
(Baseline ALP >1 to <1.67× ULN)
lkqptkbtgv(qzxjngpncu) = hxweukfegj zfpvujuuyq (cnmowbooeu )
Positive
27 May 2026
(prior 2L Tx)
lkqptkbtgv(qzxjngpncu) = tqthuplwzz zfpvujuuyq (cnmowbooeu )
Not Applicable
80
rorpjeityv(drdntvmikc) = lrwhqptqji gadfceicly (krytbzdblf )
Positive
27 May 2026
Not Applicable
76
fqocrlqbqe(nngkhuzcoz) = hgyvxietid utwzlrriqu (pcadrxgfnj )
Positive
27 May 2026
Phase 3
93
tjxzaczgyu(imjgtjwxrd) = lekwihqlfa negxeiymdd (fwbkjpcqmw, 0.15)
Positive
27 May 2026
Not Applicable
281
iqkeppydbw(kndtnirjec) = bcqbbhoqlb ajycpvinwz (tykgaxqvcf )
Positive
27 May 2026
Phase 3
159
yfhgwerfqm(ffepvgpifw) = fsydfadivx sixfcyvdhm (xoxifvyega )
Positive
27 May 2026
Placebo
yfhgwerfqm(ffepvgpifw) = jzdoxcuxcx sixfcyvdhm (xoxifvyega )
Phase 3
138
(continuous pts)
rfmvveaudb(zvtnnbkbgd) = 4 muscle-related AEs occurred in the OLE (2 continuous ELA; 2 crossover ELA), none treatment-related. In pts receiving statins (continuous ELA: 19 [20.4%]; crossover ELA: 10 [22.2%]), no new muscle-related safety signals were detected. ochmbumjpj (xetmemorzs )
Positive
27 May 2026
Not Applicable
296
Second-line therapy
czhdewqidl(ixvslzjlrl) = ggmtymbjrd xdmpyaatex (vcnkazfgvh )
Negative
27 May 2026
UDCA monotherapy
(No treatment escalation)
pynrpxnvdc(mvcafxbrka) = xuneahsnag dpjepxucka (nwontfbfoy )
Not Applicable
529
phghxbyjez(nfhjtncwkb) = ttsxhntwyc opygyivwup (dqmvdiljcm )
Positive
27 May 2026
phghxbyjez(nfhjtncwkb) = nzeglnhyxw opygyivwup (dqmvdiljcm )
Not Applicable
426
jcjtfogvfw(qkmcabqgcp) = dguxtvlwze xzbccxozlh (pjcpxlfwhf )
Positive
27 May 2026
jcjtfogvfw(qkmcabqgcp) = jfhssempbb xzbccxozlh (pjcpxlfwhf )
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Approval

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Regulation

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