Iqirvo

(Elafibranor)

Phase 3Small molecule

Ipsen

Iqirvo is one of 114 small molecule programs targeting Hepatitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

113

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HepatitisActive, not recruiting

Primary Biliary CirrhosisActive, not recruiting

Primary Biliary CholangitisActive, not recruiting

Primary Sclerosing CholangitisRecruiting

Primary Biliary Cholangitis (PBC)Recruiting

Sclerosing CholangitisActive, not recruiting

HepatitisPhase 2

Active, not recruiting

Primary Biliary CirrhosisPhase 3

Active, not recruiting

Primary Biliary CholangitisPhase 3

Active, not recruiting

Primary Sclerosing CholangitisPhase 3

Recruiting

Primary Biliary Cholangitis (PBC)Phase 3

Recruiting

Sclerosing CholangitisPhase 2

Active, not recruiting

Competition

Competitive Landscape

237 competitors in Hepatitis

#DrugCompanyPhaseTrials

Actos

Takeda

Phase 3

4 2

Cysteine Hydrochloride

Novartis

Phase 3

3 3

Crestor

AstraZeneca

Phase 3

1 4

Iqirvo

Ipsen

Phase 3

2 5

Aquasol E

NNational Eye Institute (NEI)

Phase 3

2 6

Amoxil

GGlobal Antibiotics Research and Development Partnership

Phase 3

1 7

Cervarix

GSK

Phase 3

1 8

Prevnar

GSK

Phase 3

1 9

Rimonabant

Sanofi

Phase 3

1 10

Hepatitis B Vaccine

Sanofi

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Sclerosing Cholangitis

NCT05627362

Q4 2028

Phase 3Active, not recruiting

Primary Biliary Cirrhosis

NCT04526665

Q2 2029

Phase 3Recruiting

Primary Biliary Cholangitis (PBC)

NCT06016842

Q2 2031

Phase 3Recruiting

Primary Sclerosing Cholangitis

NCT07387549

Clinical

Trials by Indication[1]

AFib4 trials

Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

Completed· Ipsen logo

Ipsen·Phase 1·NCT05543369·48 enrolled

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

Completed·GGenfit·Phase 1·NCT03765671·30 enrolled

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Completed·GGenfit·Phase 1·NCT03844555·23 enrolled

Show 1 more trial

A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet

Completed· Ipsen logo

Ipsen·Phase 1·NCT05564208·34 enrolled

Primary Biliary Cholangitis3 trials

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Completed·GGenfit·Phase 2·NCT03124108·45 enrolled

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.

Completed· Ipsen logo

Ipsen·Phase 3·NCT06383403·92 enrolled

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 recruiting· Ipsen logo

Ipsen·Phase 3·NCT06730061·18 enrolled

Hepatitis2 trials

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

Terminated·GGenfit·Phase 3·NCT02704403·2,157 enrolled

Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)

Terminated·GGenfit·Phase 2·NCT03883607·10 enrolled

Sclerosing Cholangitis1 trial

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

Active, not recruiting· Ipsen logo

Ipsen·Phase 2·NCT05627362·68 enrolled

Nonalcoholic Fatty Liver1 trial

Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

Terminated·GGenfit·Phase 2·NCT03953456·17 enrolled

5 more indications

Elderly1 trial

Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

Completed·GGenfit·Phase 1·NCT04171752·21 enrolled

Indomethacin1 trial

Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin

Completed·GGenfit·Phase 1·NCT03985969·26 enrolled

Primary Biliary Cholangitis (PBC)1 trial

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)

Recruiting· Ipsen logo

Ipsen·Phase 3·NCT06016842·276 enrolled

Primary Biliary Cirrhosis1 trial

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 recruiting· Ipsen logo

Ipsen·Phase 3·NCT04526665·161 enrolled

Primary Sclerosing Cholangitis1 trial

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

Recruiting· Ipsen logo

Ipsen·Phase 3·NCT07387549·350 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 10, 2024

IQIRVO

NDA NDA218860

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Elafibranor. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Elafibranor compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Elafibranor. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218860). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Iqirvo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Ipsen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Ipsen

Patent Landscape[5]

Patent Cliff

Mar 30, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11857523Mar 30, 2037

11850223Mar 30, 2037

11331292Mar 30, 2037

11185519Mar 30, 2037

12310935Mar 30, 2037

4 more patents

12295928Mar 30, 2037

12295927Mar 30, 2037

12233038Mar 30, 2037

12589086Mar 30, 2037

Iqirvo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2028

Q2 2029

Q2 2031

Trials by Indication[1]

AFib4 trials

Primary Biliary Cholangitis3 trials

Hepatitis2 trials

Sclerosing Cholangitis1 trial

Nonalcoholic Fatty Liver1 trial

Elderly1 trial

Indomethacin1 trial

Primary Biliary Cholangitis (PBC)1 trial

Primary Biliary Cirrhosis1 trial

Primary Sclerosing Cholangitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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