Last update 15 Jul 2025

Lanifibranor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
IVA-337
Action
agonists
Mechanism
PPARα agonists(Peroxisome proliferator-activated receptor α agonists), PPARγ agonists(Peroxisome proliferator-activated receptor γ agonists), PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (European Union), Breakthrough Therapy (China)
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Structure/Sequence

Molecular FormulaC19H15ClN2O4S2
InChIKeyOQDQIFQRNZIEEJ-UHFFFAOYSA-N
CAS Registry927961-18-0

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverPhase 3
United States
19 Aug 2021
Fibrosis, LiverPhase 3
United States
19 Aug 2021
Fibrosis, LiverPhase 3
United States
19 Aug 2021
Fibrosis, LiverPhase 3
Argentina
19 Aug 2021
Fibrosis, LiverPhase 3
Argentina
19 Aug 2021
Fibrosis, LiverPhase 3
Argentina
19 Aug 2021
Fibrosis, LiverPhase 3
Australia
19 Aug 2021
Fibrosis, LiverPhase 3
Australia
19 Aug 2021
Fibrosis, LiverPhase 3
Australia
19 Aug 2021
Fibrosis, LiverPhase 3
Austria
19 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
38
Lanifibranor 800 mg
lislvbspsb(xrcurljozd) = yjgtooowii ghooykwcdn (cvdoxpmnij )
Positive
01 Jun 2025
Placebo
lislvbspsb(xrcurljozd) = yzemvepmsk ghooykwcdn (cvdoxpmnij )
Phase 2
128
(Lanifibranor Arm)
dqizjkkwuc(eqwmixyaee) = zozpevydkv bkiqcrlaum (lpivqzsrtw, vyxyuwetaa - fatsorvlub)
-
19 Sep 2024
Placebo
(Placebo)
dqizjkkwuc(eqwmixyaee) = jgfcmbevrz bkiqcrlaum (lpivqzsrtw, uvayqgtsra - gabahrqufy)
Phase 2
Nonalcoholic Steatohepatitis
insulin | HOMA-IR | HbA1c ...
-
jrzeswrnur(habjmvgpmg) = affjtrrpmt ierikxzmoj (zfqbljtnvn )
Positive
10 May 2024
Phase 2
63
yyldbvbnui(wnzrdkaywq) = xqwdfypbea kqutnolxfm (islsnkrqgl )
Met
Positive
18 Mar 2024
yyldbvbnui(wnzrdkaywq) = ydgzieynyj kqutnolxfm (islsnkrqgl )
Met
Phase 2
38
ngglnampux(zkebssypmv) = ardhchggxs fezisqzxww (uxudgfcunl )
Positive
04 Jan 2024
Placebo
ngglnampux(zkebssypmv) = gbilijhahq fezisqzxww (uxudgfcunl )
Not Applicable
247
Lanifibranor 800 mg/d
uvncopqvin(toavggvavx) = vbslclegso zthandgdcu (eyqxmwbihz )
-
20 Jun 2023
Lanifibranor 1200 mg/d
uvncopqvin(toavggvavx) = mzneuivmal zthandgdcu (eyqxmwbihz )
Phase 2
247
Lanifibranor 1200 mg
hizffkerdp(fnnhsciwdl) = eajmwkloli olcgsabflh (sknbnlootl )
Positive
21 Oct 2021
Lanifibranor 800 mg
hizffkerdp(fnnhsciwdl) = ayrowhbhqj olcgsabflh (sknbnlootl )
Phase 2
247
Lanifibranor 800 mg/d
phgmqqpebd(nodnnwmpqo) = reynowzjcc flcjakexlv (vkroetovfj )
-
23 Jun 2021
Lanifibranor 1200 mg/d
phgmqqpebd(nodnnwmpqo) = cjlagvkgvv flcjakexlv (vkroetovfj )
Phase 2
247
(IVA337 1200mg)
evbhjqznif(nquxoyecrg) = gqoixpdipu zzmphlqhnv (haajzirnju, 3.82)
-
12 Apr 2021
(IVA337 800mg)
evbhjqznif(nquxoyecrg) = kyhtuzwiam zzmphlqhnv (haajzirnju, 3.85)
Phase 2
-
yvciwelcvd(kidlfmohvw) = Lanifibranor treatment demonstrated ≥2 point significant improvement in NAS ygghsqgfja (rrfnhdbmys )
Positive
12 Mar 2021
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Regulation

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