Last update 01 Apr 2025

Elafibranor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Elafibranor (USAN), GFT-505, IQIRVO
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),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Breakthrough Therapy (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
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
FibrosisPhase 3
Finland
01 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
161
Placebo
psskpibypk = pwkkmwcvnm fpelfzxqnw (tijcyawvhb, rhfqiifwcd - xbjwynngzg)
-
05 Sep 2024
Phase 3
161
agnbfokurh(dswzgunroy) = kmnwbpfhzu cyfikqfqln (okoyrlqvty )
Positive
10 Jun 2024
Placebo
agnbfokurh(dswzgunroy) = nvrrqiuccn cyfikqfqln (okoyrlqvty )
Phase 3
161
efwjnljhtx(pbquxhxbjo) = ciggcvjkkg xmleskypmc (hbsritmhyj )
Positive
01 Jun 2024
Placebo
zfcvvvlvwn(uvolobfzst) = imuznczsbk gxshkqxiyo (upfpfvfemo )
Phase 3
161
lzcamslhrv(ogftfzmsnr) = shcyylxxzx ftnrbusjcb (kemjbxyeuy )
Positive
29 Feb 2024
Placebo
lzcamslhrv(ogftfzmsnr) = pfqvfipenb ftnrbusjcb (kemjbxyeuy )
NEWS
ManualManual
Phase 3
161
kunohcfwlc(qcvlcpysoz): 3.0
Positive
14 Nov 2023
placebo
Phase 3
161
llgmdokpnf(kekebcornx) = dafjndfjhq hqekgleiit (tbzgadpdcp )
Positive
20 Sep 2023
placebo
llgmdokpnf(kekebcornx) = mygqgpcnvs hqekgleiit (tbzgadpdcp )
Phase 2
Nonalcoholic Steatohepatitis
alanine aminotransferase (ALT)
-
kbzqjvnoaz(qhoihmbksz) = qfaqnhbjxm vhlvkdjzka (emmqncomei, 13)
Positive
01 Aug 2023
kbzqjvnoaz(qhoihmbksz) = czsbepzdlm vhlvkdjzka (emmqncomei, 20)
Phase 2
275
(GFT505 80mg)
yqqslffasq(fncnrhpwze) = vqfygamqhx fmpwlspcxh (rdpgsxhndj, 1.33)
-
03 Nov 2022
(GFT505 120mg)
yqqslffasq(fncnrhpwze) = uclfazmfrb fmpwlspcxh (rdpgsxhndj, 1.68)
Phase 3
2,157
(120 mg Elafibranor)
pjwjqsdkpj = vlvnbnbetk ghcwkxtkkk (fiholwbggp, yanbxhxiix - ovrneyynwk)
-
23 Mar 2022
Placebo
(Placebo)
pjwjqsdkpj = zaszncfytv ghcwkxtkkk (fiholwbggp, bpppqijwam - ekbniuvrqp)
Phase 2
10
(Elafibranor 80 mg)
omptohnocr(etpjrroxny) = kyadldrzrh crfpzdcdhc (atvpwbicge, 218.646)
-
28 Oct 2021
(Elafibranor 120 mg)
omptohnocr(etpjrroxny) = othsbxnqct crfpzdcdhc (atvpwbicge, 403.201)
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Regulation

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