Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NTZ on top of SOC, Nitazoxanide
NTZ · 3 trials · 8 indications
Safety defined as the incidence, relatedness, and severity (NCI-CTCAE v6.0 grade) of TEAEs including SAEs (comprising the evaluation of vital signs, ECGs, and laboratory parameters).
Plasma pharmacokinetic (PK) parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
In participants with moderate and severe hepatic impairment compared to healthy volunteers
In participants with moderate and severe hepatic impairment compared to healthy volunteers
In participants with moderate and severe hepatic impairment compared to healthy volunteers
| Arm | Type | Description |
|---|---|---|
| NTZ 500mg BID on top of SOC | EXPERIMENTAL | Treatment period NTZ 500mg BID on top of SOC during 7 days. |
| Healthy Control Match (RF ≥ 90 mL/min) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Mild Renal Impairment (RF ≥ 60 to < 90 mL/min) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Severe Renal Impairment (RF < 30 mL/min and not on dialysis) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Healthy Control Match (Normal hepatic function) | EXPERIMENTAL | NTZ 500 mg twice a day for 7 days |
| Moderate Child-Pugh B (Moderate hepatic impairment) | EXPERIMENTAL | NTZ 500 mg twice a day for 7 days |
| Severe Child-Pugh C (Severe hepatic impairment) | EXPERIMENTAL | NTZ 500 mg twice a day for 7 days |
| Name | Type | Description |
|---|---|---|
| NTZ 500mg BID on top of SOC | DRUG | Treatment period NTZ 500mg BID on top of SOC |
| Nitazoxanide | DRUG | 500 mg Twice Daily for 7 days |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings, and/or histology) * Recent acute clinica...
NTZ is an investigational small molecule drug being developed by Genfit SA (ticker GNFT) for acute decompensation of liver cirrhosis. It is given at 500 mg twice daily on top of standard of care. NTZ is currently in Phase 2 clinical development and is not yet approved for any indication.
NTZ is being studied for use in patients with acute decompensation of liver cirrhosis who are at high risk of progressing to acute-on-chronic liver failure, or who already have established acute-on-chronic liver failure. It is added to standard of care at a dose of 500 mg twice daily. It remains investigational.
NTZ is being developed by Genfit SA, which trades under the ticker GNFT as a sponsored ADR. Genfit is the sponsor of the Phase 2 clinical study evaluating NTZ in patients with acute decompensation of liver cirrhosis.
NTZ is in Phase 2 clinical development. The ongoing study is a Phase 2 trial in patients with acute decompensation of liver cirrhosis. NTZ has not completed any trials and is not approved; it remains an investigational drug.
NTZ is being evaluated in one Phase 2 clinical trial, NCT07694297, titled a 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. The trial is not yet recruiting and plans to enroll 16 patients.