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About liver disease

Clinical trials

Before obtaining market approval from the regulatory authorities (including the Food and Drug Administration (FDA) in the US ; the European Medicines Agency (EMA) in Europe), a drug candidate has to demonstrate its efficacy, safety, and beneficial profile in human clinical trials.
By participating in the clinical trials that we conduct on our drug candidates, patients can benefit from an innovative treatment, where there may be no existing treatment or only therapeutic solutions that are inefficient or poorly tolerated.
Through our commitment to transparency, we provide new data to patients, physicians, and patient associations, with the aim of contributing to progress in therapeutic research.

Clinical trials are always conducted in volunteers, whether healthy or not. These trials occur in 4 phases:

Phase 1 trials

They enable the evaluation of the safety of the drug candidate. Most of the time they are conducted in healthy volunteers.
Before entering First-In-Man clinical trials, the study drug must of course have demonstrated that it has a real potential to treat the targeted disease, as shown through preclinical testing in cellular and animal models. Its safety of use is also assured by numerous regulatory preclinical studies, the results of which are recorded in an IND (Investigational New Drug) application or an IMPD (Investigational Medicinal Product Dossier) that are validated by the Authorities (FDA or other national health authorities).

 

Phase 2 trials

Phase 2 trials are performed in a homogeneous group of volunteers suffering from the targeted disease. This Phase can be divided into Phase 2a and Phase 2b, that respectively aim at demonstrating that the drug candidate is effective and safe, and at finding the optimal therapeutic dose.

 

Phase 3 trials

In Phase 3 trials, the efficacy and safety of the drug candidate is confirmed in a large patient population.
When Phase 1, 2 and 3 trials have been successfully completed, demonstrating the safety and the efficacy of the drug candidate, a New Drug Application (NDA) can be submitted to the regulatory agencies to obtain the marketing authorization for the drug.

Phase 4 trials

Phase 4 trials are conducted once the drug is on the market, in order to further evaluate its efficacy and safety in real life conditions.
Information concerning all the clinical trials that we conduct at Genfit are accessible online on ClinicalTrials.gov, enabling patients, physicians and patient support groups to be informed about the enrollment process.

ClinicalTrials.gov
 
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