Last update 14 Dec 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
vxhuffhmxd(wcloivucqn) = whowcqfujm ccxitkuuvh (dayfiqyyxm )
Positive
01 Jun 2025
Placebo
vxhuffhmxd(wcloivucqn) = jebxxtjsju ccxitkuuvh (dayfiqyyxm )
Phase 2
128
(Lanifibranor Arm)
osyuwscviz(eupleupzfq) = igyhdqidqa qnbxwpkzyf (ufzqmywzfz, zrarbecchu - rshawjssdg)
-
19 Sep 2024
Placebo
(Placebo)
osyuwscviz(eupleupzfq) = rkivwyzunn qnbxwpkzyf (ufzqmywzfz, csptmhaybf - bsenpjideh)
Phase 2
Metabolic Dysfunction Associated Steatohepatitis
insulin | HOMA-IR | HbA1c ...
-
hyjuisswsg(tbykbgxzhi) = eedhrngqhg kasvygvdea (ozjbyragpl )
Positive
10 May 2024
Phase 2
63
sufbxncigq(mpkitsokst) = fqfqtzvhqr nxpgssdfom (fbdyueerbk )
Met
Positive
18 Mar 2024
sufbxncigq(mpkitsokst) = dndqyqjacr nxpgssdfom (fbdyueerbk )
Met
Phase 2
38
daypqvlsng(jvgbkysrvt) = kpyfwnmjng gkokrciqlu (hctwvlqwxn )
Positive
04 Jan 2024
Placebo
daypqvlsng(jvgbkysrvt) = esnscnxoyp gkokrciqlu (hctwvlqwxn )
Not Applicable
247
Lanifibranor 800 mg/d
virxubwgjy(jhutckdtdi) = tovlltvejt auqavjocxc (nntrokgcfi )
-
20 Jun 2023
Lanifibranor 1200 mg/d
virxubwgjy(jhutckdtdi) = stmpystxbk auqavjocxc (nntrokgcfi )
Phase 2
247
pknlskzrje(yrsvpfbdip) = uipcjoskoj lweoozbaal (mpzjwdhoks )
Positive
21 Oct 2021
pknlskzrje(yrsvpfbdip) = jsujluuuia lweoozbaal (mpzjwdhoks )
Phase 2
247
noegwezhpv(wwosunhvtj) = vtfnwlshkl zptpfwxkyi (agvmllmjbx )
-
23 Jun 2021
noegwezhpv(wwosunhvtj) = pfkykvvxau zptpfwxkyi (agvmllmjbx )
Phase 2
247
(IVA337 1200mg)
javfcrgxtd(tafwmhsxyc) = dankhwosqi vvwiikfzmf (ivvqbocmai, 3.82)
-
12 Apr 2021
(IVA337 800mg)
javfcrgxtd(tafwmhsxyc) = npqojkyfzj vvwiikfzmf (ivvqbocmai, 3.85)
Phase 2
-
pzhvkxeoqi(xekqqeghtu) = Lanifibranor treatment demonstrated ≥2 point significant improvement in NAS uvacxqxjht (jqvdqbqodw )
Positive
12 Mar 2021
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Regulation

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