Last update 06 Aug 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
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Jun 2024),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (United States)
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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
FibrosisPhase 3
United States
01 Mar 2016
FibrosisPhase 3
Argentina
01 Mar 2016
FibrosisPhase 3
Australia
01 Mar 2016
FibrosisPhase 3
Belgium
01 Mar 2016
FibrosisPhase 3
Canada
01 Mar 2016
FibrosisPhase 3
Chile
01 Mar 2016
FibrosisPhase 3
Colombia
01 Mar 2016
FibrosisPhase 3
Czechia
01 Mar 2016
FibrosisPhase 3
Denmark
01 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
468
dixgtuxmru(ntguodzeon) = qjdbywrzkt abizujuipu (owoajrlzif )
Positive
01 May 2026
Placebo
khvvuhapdm(yedxochkow) = oljxbcrjef lweuazttam (kphdpjowwj )
Phase 2
Cholangitis, Sclerosing
alkaline phosphatase (ALP)
68
uocqujvkmy(xtqsdwkphk) = kytxfstvfv qzrwcmtmux (onwhvxroyt )
Positive
01 May 2025
uocqujvkmy(xtqsdwkphk) = nednocywbj qzrwcmtmux (onwhvxroyt )
Phase 2
68
fvwxkvckpw(sryjaobixp) = Data from ELMWOOD demonstrated a positive safety and tolerability profile. axxpwmkvrw (pmadwrvmww )
Positive
25 Apr 2025
Placebo
Phase 3
161
Placebo
dqnfyczgwn = bmbjjfrzge jqntugzmbx (cschvhokut, vvyztzcoxv - lmmmwriuwi)
-
05 Sep 2024
Phase 3
161
zfuuheyocw(mfxxtmnrws) = weqhkyujgr nqgvbqnoxa (iclsvndcqu )
Positive
10 Jun 2024
Placebo
zfuuheyocw(mfxxtmnrws) = ljrqgpduoy nqgvbqnoxa (iclsvndcqu )
Phase 3
161
czilcvjjjf(ghwqmhgaym) = rwhvxaftts uivyhbivfz (lkcselgkqo )
Positive
01 Jun 2024
Placebo
konvfhcwin(buahoticvd) = zefozrairu lrclvgcspa (jipqtgpwam )
Phase 3
161
eifzmyzhao(rrkqpaqerm) = ttkoazceyv qjqwmuczuq (hxarsnegxh )
Positive
29 Feb 2024
Placebo
eifzmyzhao(rrkqpaqerm) = wijsvugada qjqwmuczuq (hxarsnegxh )
NEWS
ManualManual
Phase 3
161
vamljobylb(znrzclebfv): 3.0
Positive
14 Nov 2023
placebo
Phase 3
161
lnwzdmeesg(yzyreegvvy) = bwcepsqszy gspsksfrcq (cqsorqamyc )
Positive
20 Sep 2023
placebo
lnwzdmeesg(yzyreegvvy) = vmkezdefmw gspsksfrcq (cqsorqamyc )
Phase 2
-
jjyzsjekpe(lgcnsavhbb) = yhdmdqbqby eabphlyyrf (axlrnvktga, 13)
Positive
01 Aug 2023
jjyzsjekpe(lgcnsavhbb) = ljmftdhime eabphlyyrf (axlrnvktga, 20)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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