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elafibranor

Trade name: IQIRVO

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Jun 10, 2024

Elafibranor, sold under the brand name Iqirvo, is a medication used for the treatment of primary biliary cholangitis. — Wikipedia

Clinical trial activity

23 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
14
Phase 3
5
Phase 4
0

Earliest trial started Jan 1, 2009 (NCT01271751)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

  3. Jul 25, 2019

    Orphan Drug Designation

2020s

  1. Jun 10, 2024

    Ipsen — Earliest FDA Approval

  2. Jun 10, 2024

    Ipsen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughJun 10, 2024

Chemistry & pharmacology

Loading structure…

SMILES

CSc1ccc(C(=O)/C=C/c2cc(C)c(OC(C)(C)C(=O)O)c(C)c2)cc1
Mol. weight
384.5 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid
  • elafibranor
  • elafibranor
  • elafibranor
  • gft505
  • gft505
  • gft505
  • gft505
  • gft-505
  • gft-505

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06730061Phase 3Dec 9, 2024Ipsen
NCT06383403Phase 3Jul 9, 2024Ipsen
NCT06016842Phase 3Aug 31, 2023Ipsen
NCT05627362Phase 2Dec 1, 2022Ipsen
NCT05564208Phase 1Oct 27, 2022Ipsen
NCT05543369Phase 1Sep 19, 2022Ipsen
NCT04526665Phase 3Sep 24, 2020Genfit
NCT04171752Phase 1Nov 22, 2019Genfit
NCT03953456Phase 2Aug 31, 2019Genfit
NCT03985969Phase 1Jun 30, 2019Genfit
NCT03883607Phase 2May 2, 2019Genfit
NCT03844555Phase 1Feb 28, 2019Genfit
NCT03765671Phase 1Dec 12, 2018Genfit, Syneos Health, University of Miami
NCT03124108Phase 2Apr 5, 2017Genfit
NCT02704403Phase 3Mar 1, 2016Genfit
NCT02142127Phase 1Apr 1, 2014Genfit, SGS Life Sciences
NCT02091310Phase 1Feb 1, 2014Banook Group, Eurofins, Genfit, PHINC DEVELOPMENT
NCT01694849Phase 2Sep 1, 2012Genfit, Gottfried Wilhelm Leibniz Universität Hannover, Naturalpha, Newcastle University, Premier Research Group, Radboud University, University of Antwerp, University of Seville, University of Turin, Virginia Commonwealth University
NCT01474161Phase 1Nov 1, 2011Genfit, Naturalpha, SGS Life Sciences
NCT01271777Phase 2Jan 1, 2011Genfit, University of Nantes
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenfitFor profit171732009
IpsenFor profit6632022
NaturalphaFor profit2022011
SGS Life SciencesFor profit2012011
University of NantesAcademic/Hospital2012010
Banook GroupFor profit1012014
EurofinsFor profit1012014
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1012012
Newcastle UniversityAcademic/Hospital1012012
PHINC DEVELOPMENTFor profit1012014
Premier Research GroupFor profit1012012
Radboud UniversityAcademic/Hospital1012012
Syneos HealthFor profit1012018
University of AntwerpAcademic/Hospital1012012
University of MiamiAcademic/Hospital1012018
University of SevilleAcademic/Hospital1012012
University of TurinAcademic/Hospital1012012
Virginia Commonwealth UniversityAcademic/Hospital1012012
18 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
IpsenFor profitNDAJun 10, 2024