Iqirvo

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Primary Biliary CholangitisPrimary Biliary CirrhosisPrimary Sclerosing CholangitisPrimary Biliary Cholangitis (PBC)

10 competitors in Primary Biliary Cholangitis

#DrugCompanyPhaseTrials

1

Cellcept

Roche

Approved

12

Ocaliva

IIntercept Pharmaceuticals

Approved

43

Tricor

JJagotec

Phase 3

44

Lipaglyn

ZZydus Therapeutics Inc.

Phase 3

55

Iqirvo

Ipsen

Phase 3

36

Selincro

IIndivior Inc.

Phase 2

17

CS0159

CCascade Pharmaceuticals, Inc

Phase 3

28

Seladelpar

Gilead

Phase 3

69

Volixibat

MMirum Pharmaceuticals, Inc.

Phase 2

110

Ocaliva

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

1

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

AFib4 trials

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·Phase 1·NCT05564208·34 enrolled

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Completed·GGenfit·Phase 1·NCT03844555·23 enrolled

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

Completed·GGenfit·Phase 1·NCT03765671·30 enrolled

Show 1 more trial

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

Completed·Ipsen·Phase 1·NCT05543369·48 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 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·Phase 3·NCT06730061·18 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·Phase 3·NCT06383403·92 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

Primary Sclerosing Cholangitis2 trials

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).

Active, not recruiting·Ipsen·Phase 2·NCT05627362·68 enrolled

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·Phase 3·NCT07387549·350 enrolled

Indomethacin1 trial

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

Completed·GGenfit·Phase 1·NCT03985969·26 enrolled

4 more indications

Elderly1 trial

Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

Completed·GGenfit·Phase 1·NCT04171752·21 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

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·Phase 3·NCT04526665·161 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·Phase 3·NCT06016842·276 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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