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Drug

Elafibranor

Approved medicine
ClassPeroxisome proliferator-activated receptor alpha agonistResearchOngoing clinical research

Also known as Iqirvo, PROPANOIC ACID, 2-(2,6-DIMETHYL-4-((1E)-3-(4-(METHYLTHIO)PHENYL)-3-OXO-1-PROPEN-1-YL)PHENOXY)-, PROPANOIC ACID, 2-(2,6-DIMETHYL-4-(3-(4-(METHYLTHIO)PHENYL)-3-OXO-1-PROPEN-1-YL)PHENOXY)-2-METHYL-.

RxNorm2684941ChEMBLCHEMBL3707395ATCA05AX06UNII2J3H5C81A5
5
Active clinical trials
2
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: ELAFIBRANOR (NDA218860)

Regulatory2026-08-07FDA

A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC).

Clinical trial2026-08-03Results expected Q3 2031 · ClinicalTrials.gov

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)

Clinical trial2026-08-03Results expected Q2 2029 · ClinicalTrials.gov

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

Clinical trial2026-08-03Results expected Q2 2031 · ClinicalTrials.gov

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

A Phase III, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Elafibranor 80 mg in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

Clinical trial2026-07-02Results expected Q4 2026 · ClinicalTrials.gov

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Clinical trial2026-06-16Completed · ClinicalTrials.gov

Approval: Iqirvo (EMA)

Regulatory2024-09-19EMA

Approval: ELAFIBRANOR (NDA218860)

Regulatory2024-06-10FDA

A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.

Clinical trial2023-03-10Completed · ClinicalTrials.gov

A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants

Clinical trial2023-01-14Completed · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Clinical trial2020-10-28Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Elafibranor
Aliases & brands
IqirvoPROPANOIC ACID, 2-(2,6-DIMETHYL-4-((1E)-3-(4-(METHYLTHIO)PHENYL)-3-OXO-1-PROPEN-1-YL)PHENOXY)-PROPANOIC ACID, 2-(2,6-DIMETHYL-4-(3-(4-(METHYLTHIO)PHENYL)-3-OXO-1-PROPEN-1-YL)PHENOXY)-2-METHYL-
RxNorm CUI
2684941
ChEMBL ID
CHEMBL3707395
ATC codes
A05AX06
UNII
2J3H5C81A5
Primary mechanism
Peroxisome proliferator-activated receptor alpha agonist
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Peroxisome proliferator-activated receptor alpha
PPARA · Q07869
AGONISTPeroxisome proliferator-activated receptor alpha agonist
Peroxisome proliferator-activated receptor delta
PPARD · Q03181
AGONISTPeroxisome proliferator-activated receptor delta agonist

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2024-06-10 → 2024-09-19)
Earliest approval
2024-06-10
Latest approval
2024-09-19
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-08-07Label change
Label change: ELAFIBRANOR (NDA218860)
Evidence ↗
2024-06-10ApprovalMulti-authority
Approval: ELAFIBRANOR (NDA218860)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2024-09-19ApprovalMulti-authority
Approval: Iqirvo (EMA)
Indication: Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as… Show full indication

Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
2
Recruiting
6
Late-stage (III+)
8
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 16
Phase 16Phase 24Phase 36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase III, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Elafibranor 80 mg in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

Active, not recruitingPH IIIIpsenn=182032

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

RecruitingPH IIIIpsenn=3502031

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)

RecruitingPH IIIIpsenn=2762029

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

Active, not recruitingPH IIIIpsenn=1612028

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

CompletedPH IIIIpsenn=922026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

CompletedPH IIIIpsenn=922026

A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.

CompletedPH IIpsenn=482023

A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants

CompletedPH IIpsenn=342023

Phase 1, Open-label Study, in Healthy Male Volunteers to Evaluate the Potential Effect of Indomethacin on the Pharmacokinetics Parameters of Elafibranor

CompletedPH IGenfitn=262020

Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Healthy Elderly and Young Adults Volunteers

CompletedPH IGenfitn=212020

Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of Elafibranor 120 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function

CompletedPH IGenfitn=232020
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.