COMPANY

Genfit

We rely on trusted subcontractors to support a significant portion of our business activities, particularly those requiring specific regulatory approvals, such as Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). From company website Source · Oct 13, 2026

Keywords: Abdominal Obesity Acute-On-Chronic Liver Failure Renal Impairment Ascites Cholangiocarcinoma Acute Decompensation of Liver Cirrhosis Established Acute-on-Chronic Liver Failure Hepatic Encephalopathy Acute on Chronic Liver Failure Decompensated Cirrhosis Non-Alcoholic Steatohepatitis Renal Disease Kidney Disease Moderate Hepatic Impairment Severe Hepatic Impairment Liver Diseases Nonalcoholic Steatohepatitis (NASH) With Fibrosis Non Alcoholic Steatohepatitis Non-Alcoholic Fatty Liver Drug-drug Interaction Renal Insufficiency Kidney Diseases Geriatrics Primary Biliary Cholangitis Hepatic Impairment Liver Disease Type 2 Diabetes Type 2 Diabetes Mellitus Metabolic Diseases Cardiovascular Diseases Obese Dyslipidemia Insulin Resistance Type II Diabetes Mellitus Impaired Glucose Tolerance Atherogenic Dyslipidaemia GFT505 Elafibranor Nitazoxanide

Location: Loos, France · source · Oct 14, 2026

Profile checked Oct 10, 2026

23Trials (company is sponsor)

Timeline

2026-10 Trial start 2: Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acut source ↗
Aug 26, 2025 Trial start Phase 1: Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers source ↗
Aug 25, 2025 Trial start Phase 2: A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy source ↗
Mar 20, 2025 Debt Debt financing: €185M (up to, as announced), announced Mar 20, 2025. Source: company release on GlobeNewswire. source ↗
Jan 30, 2025 Debt Debt financing: €185M (up to, as announced), announced Jan 30, 2025. Source: company release on GlobeNewswire. source ↗
Aug 21, 2023 Trial start Phase 1/Phase 2: Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma source ↗
Jul 2, 2023 Trial start Phase 2: Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)® source ↗
Apr 25, 2022 Trial start Phase 1: Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects source ↗
Nov 5, 2021 Trial start Phase 1: Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients source ↗
Nov 22, 2019 Trial start Phase 1: Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers source ↗
Sep 23, 2019 Trial start Phase 1: Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin source ↗
Aug 16, 2019 Trial start Phase 2: Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL) source ↗
Jun 25, 2019 Trial start Phase 2: Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) source ↗
Feb 28, 2019 Trial start Phase 1: Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients source ↗
Dec 12, 2018 Trial start Phase 1: Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients source ↗
Apr 5, 2017 Trial start Phase 2: Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid source ↗
2016-03 Trial start 3: Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) source ↗
2014-04 Trial start Phase 1: Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers source ↗
2014-02 Trial start I: Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers source ↗
2012-09 Trial start II: Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) source ↗
2011-11 Trial start Phase 1: Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505 source ↗
2011-01 Trial start Phase 2: Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity source ↗
2010-12 Trial start Phase 2: Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus source ↗
2009-06 Trial start Phase 2: Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. source ↗
2009-01 Trial start Phase 2: Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity source ↗

Upcoming milestones

2027-08 (ESTIMATED) · 2 · Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-o · NCT07694297
2027-12 (ESTIMATED) · Phase 1/Phase 2 · Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma · NCT05874414

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Debt: amount not published. Last 2 years.

Mar 20, 2025 Debt financing: €185M (up to, as announced), announced Mar 20, 2025. Source: company release on GlobeNewswire. source ↗
Jan 30, 2025 Debt financing: €185M (up to, as announced), announced Jan 30, 2025. Source: company release on GlobeNewswire. source ↗

Clinical trials (lead sponsor) 23

Record	Title	Phase	Status	Start	Primary completion
NCT05900050	Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®	Phase 2	Terminated	Jul 2, 2023	Oct 15, 2025 (actual)
NCT05874414	Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma	Phase 1/Phase 2	Recruiting	Aug 21, 2023	2027-12 (estimated)
NCT07694297	Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure	2	Not yet recruiting	2026-10	2027-08 (estimated)
NCT07110441	Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers	Phase 1	Completed	Aug 26, 2025	Dec 1, 2025 (actual)
NCT06987968	A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy	Phase 2	Terminated	Aug 25, 2025	Sep 8, 2025 (actual)
NCT01694849	Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)	II	Completed	2012-09	2015-02 (actual)
NCT05368935	Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects	Phase 1	Completed	Apr 25, 2022	Sep 4, 2022 (actual)
NCT05116826	Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients	Phase 1	Completed	Nov 5, 2021	Apr 8, 2022 (actual)
NCT02704403	Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)	3	Terminated	2016-03	Oct 28, 2020 (actual)
NCT03883607	Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)	Phase 2	Terminated	Jun 25, 2019	Jun 16, 2020 (actual)
NCT03953456	Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)	Phase 2	Terminated	Aug 16, 2019	Mar 11, 2020 (actual)
NCT03985969	Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin	Phase 1	Completed	Sep 23, 2019	Mar 15, 2020 (actual)
NCT03844555	Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients	Phase 1	Completed	Feb 28, 2019	Mar 15, 2020 (actual)
NCT04171752	Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers	Phase 1	Completed	Nov 22, 2019	Mar 22, 2020 (actual)
NCT03124108	Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid	Phase 2	Completed	Apr 5, 2017	Oct 31, 2018 (actual)
NCT03765671	Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients	Phase 1	Completed	Dec 12, 2018	Jun 7, 2019 (actual)
NCT02142127	Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers	Phase 1	Completed	2014-04	2014-06 (actual)
NCT02091310	Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers	I	Completed	2014-02	2014-12 (actual)
NCT01474161	Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505	Phase 1	Completed	2011-11	2012-11 (actual)
NCT01271777	Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity	Phase 2	Completed	2011-01	2011-11 (actual)
NCT01261494	Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus	Phase 2	Completed	2010-12	2011-06 (actual)
NCT01275469	Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.	Phase 2	Completed	2009-06	2009-12 (actual)
NCT01271751	Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity	Phase 2	Completed	2009-01	2009-09 (actual)