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Clinical trials
catalyst calendar across sponsors →Studies where GNFT.PA is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
23 interventional · 5 with posted results
government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated CholangiocarcinomaNCT05874414Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b)Open-label · Treatment | Phase 1/2 | Recruiting | Drug: GNS561 + Trametinib | Cholangiocarcinoma | 98 | Dec 2027 | ≤ 499 d | 2026-07-13 |
| 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 FailureNCT07694297To evaluate the safety of 500 mg BID NTZ administered perorallyOpen-label · Treatment | Phase 2 | Not yet recruiting | Drug: NTZ 500mg BID on top of SOC | Acute Decompensation of Liver Cirrhosis, Established Acute-on-Chronic Liver Failure | 16 | Aug 2027 | ≤ 377 d | 2026-07-09 |
| Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy VolunteersNCT07110441Maximum Concentration (Cmax)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Single Dose G1090N, Multiple dosing of G1090N | Acute-on-Chronic Liver Failure | 52 | 2025-12-01actual | — | 2026-01-16 |
| Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®NCT05900050results2026-07-23Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: VS-01 on top of SOC · Other: SOC (Control Group) | Acute-On-Chronic Liver Failure, Ascites | 15 | 2025-10-15actual | — | 2026-07-23 |
| 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 EncephalopathyNCT06987968Time to improvement of OHE as assessed by HEGIRandomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor decision | Drug: VS-01 on top of SOC (Active Treatment Group), SOC | Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF), Decompensated Cirrhosis | 3 | 2025-09-08actual | — | 2026-01-12 |
| Nitazoxanide Pharmacokinetic Parameters in Renal Impaired SubjectsNCT05368935Maximum observed plasma concentration (Cmax)Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Nitazoxanide | Renal Impairment, Renal Disease, Kidney Disease | 77 | 2022-09-04actual | — | 2022-10-28 |
| Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired PatientsNCT05116826Area under the plasma concentration time curve (AUC) from time zero to 12h (AUC0-12)Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Nitazoxanide | Moderate Hepatic Impairment, Severe Hepatic Impairment, Liver Diseases | 25 | 2022-04-08actual | — | 2022-10-14 |
| Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)NCT02704403results2022-03-23Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of FibrosisRandomized · Quadruple-masked · TreatmentStudy Protocol: Local Protocols ↗ · Study Protocol: General Protocols ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified | Drug: Elafibranor, Placebo | Nonalcoholic Steatohepatitis (NASH) With Fibrosis | 2,157 | 2020-10-28actual | — | 2022-03-23 |
| Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)NCT03883607results2021-10-28Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Elafibranor and Its Active Metabolite (GFT1007)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Due to lack of efficacy (but not due to safety) in a Phase 3 trial of elafibranor in adult participants with NASH and fibrosis, this study in pediatric NASH was prematurely terminated | Drug: Elafibranor 80mg, Elafibranor 120mg | Non Alcoholic Steatohepatitis | 10 | 2020-06-16actual | — | 2021-10-28 |
| Elafibranor Pharmacokinetic Parameters in Elderly Healthy VolunteersNCT04171752Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metaboliteNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: elafibranor | Geriatrics, Healthy | 21 | 2020-03-22actual | — | 2020-08-13 |
| Elafibranor Pharmacokinetic Parameters in Renal Impaired PatientsNCT03844555Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metaboliteNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Elafibranor | Renal Impairment, Renal Insufficiency, Kidney Diseases, Pharmacokinetics | 23 | 2020-03-15actual | — | 2020-08-13 |
| Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and IndomethacinNCT03985969Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞))Open-label · Basic science | Phase 1 | Completed | Drug: elafibranor, CHRONO-INDOCID | Drug-drug Interaction | 26 | 2020-03-15actual | — | 2020-08-13 |
| Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)NCT03953456Change in relative amount of saturated fatty acids in the liverRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Continuation of the trial cannot serve a scientific purpose | Drug: elafibranor 120mg, Placebo | Non-Alcoholic Fatty Liver | 17 | 2020-03-11actual | — | 2020-08-31 |
| Elafibranor Pharmacokinetic Parameters in Hepatic Impaired PatientsNCT03765671Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metaboliteNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Elafibranor | Hepatic Impairment, Liver Disease, Pharmacokinetics | 30 | 2019-06-07actual | — | 2019-08-22 |
| Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic AcidNCT03124108results2019-09-24Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Elafibranor 80 mg, Elafibranor 120 mg, Placebo | Primary Biliary Cholangitis (PBC) | 45 | 2018-10-31actual | — | 2019-09-24 |
| Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)NCT01694849results2022-11-03Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GFT505 80mg, GFT505 120mg, Placebo | Non-Alcoholic Steatohepatitis (NASH) | 275 | Feb 2015actual | — | 2022-11-03 |
| Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy VolunteersNCT02091310Safety parameters such as adverse event monitoring, vital signs, ECG, and clinical laboratory tests (Study Part I)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Placebo, GFT505, Moxifloxacin 400 mg | Healthy Volunteers | 200 | Dec 2014actual | — | 2015-03-10 |
| Mass Balance Study of 14C-labelled GFT505 in Healthy VolunteersNCT02142127Excretion balance of radiocarbon in whole blood, blood cells, plasma, urine, feces, and expired air after a single oral dose of 14C-labelled GFT505.Open-label · Treatment | Phase 1 | Completed | Drug: 14C-labelled GFT505 120 mg | Healthy | 6 | Jun 2014actual | — | 2015-05-29 |
| Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505NCT01474161Pharmacokinetics parameters (Study Part I)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: GFT505 120mg - old formulation, GFT505 120mg - new formulation, GFT505 180mg - new formulation, GFT505 240mg - new formulation, GFT505 300mg - new formulation, Placebo | Type 2 Diabetes, Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases, Obese, Dyslipidemia | 96 | Nov 2012actual | — | 2012-11-27 |
| Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal ObesityNCT01271777Glucose Infusion Rate (GIR)Randomized · Single-masked · Treatment | Phase 2 | Completed | Drug: GFT505 80mg, Placebo | Insulin Resistance, Abdominal Obesity | 22 | Nov 2011actual | — | 2012-09-24 |
| Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes MellitusNCT01261494HbA1cRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GFT505 80mg, Placebo | Type II Diabetes Mellitus | 97 | Jun 2011actual | — | 2011-07-13 |
| Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.NCT01275469Oral Glucose test Tolerance (OGTT)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GFT505 80mg, Placebo | Impaired Glucose Tolerance, Abdominal Obesity | 47 | Dec 2009actual | — | 2011-01-12 |
| Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal ObesityNCT01271751Decrease in serum Triglycerides (TG) levelRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GFT505 80mg, Placebo | Atherogenic Dyslipidaemia, Abdominal Obesity | 96 | Sep 2009actual | — | 2011-01-07 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19