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Genfit SA (FR:GNFT)
:GNFT
Soc, Vs-01 On Top Of Soc (Active Treatment Group)
Decompensated Cirrhosis, Hepatic Encephalopathy, Acute On Chronic Liver Failure (Aclf)
Phase II
Terminated
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
May 07, 2025
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Vs-01 On Top Of Soc, Soc (Control Group)
Acute-On-Chronic Liver Failure, Ascites
Phase II
Terminated
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
Jun 02, 2023
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Genfit SA (GNFT) have in its pipeline
GNFT is currently developing the following drugs: Soc, Vs-01 On Top Of Soc (Active Treatment Group), Vs-01 On Top Of Soc, Soc (Control Group). These drug candidates are in various stages of clinical development as the company works toward FDA approval.