- First patient enrolled in a Phase 2 Trial recruiting adults with Primary Biliary Cholangitis (PBC).
- Launch of the next phase, for the development of a new non-invasive In Vitro Diagnostic (IVD) test based on biomarkers aimed at identifying NASH patients eligible for treatment.
- Detailed results of the Phase IIb clinical trial evaluating elafibranor as a treatment for NASH (administered orally in a single daily dose) were published in the prestigious Gastroenterology journal.
- First patient is enrolled in the Phase III RESOLVE-IT clinical trial, intended to evaluate elafibranor as a treatment for NASH.
- Authorization of the FDA to launch a Phase II clinical trial of elafibranor in a new indication – Primary Biliary Cholangitis (PBC), a rare disease with unmet need and only two orphan designated drugs approved to date.
- Initiation of the first juvenile toxicity studies of the Pediatric Investigation Plan (PIP) of elafibranor in NASH, following the favorable opinion of the European Medicines Agency (EMA).
- Launch of The NASH Education Program™, endowment fund created at GENFIT’s initiative dedicated to the development and funding of disease awareness activities targeting the medical field and general public.
- In March, elafibranor (GFT505), GENFIT’s lead pipeline product, completed a positive Phase 2b study in NASH.
- In June, the World Health Organization (WHO) approved the international non-proprietary name (INN, or generic name) elafibranor for the drug candidate previously referred to as GFT505.
- In September, GENFIT announces that it has designed a diagnostic tool based on algorithms including a new type of NASH biomarkers: small non-coding RNAs or miRNAs. It should allow – without invasive liver biopsy – to identify NASH patients that should be treated with Elafibranor or other appropriate treatment.
- In November 2015, GENFIT announced the design of the global phase 3 trial RESOLVE-IT to evaluate the benefits of Elafibranor treatment on NASH patients.
- In September, GENFIT celebrated its 15th birthday, marking a turning point in the achievement of its research goals.
- On April 17, 2014 GENFIT is listed on the Euronext Paris regulated market – Compartment B (GNFT)
2010 – 2013
GENFIT positions itself as a pioneer in the discovery of therapeutic solutions for NASH.
- Elafibranor, drug candidate among the most advanced in its therapeutic area, enters Phase 2b for the treatment of NASH.
- GENFIT and Sanofi extend 10 years of collaboration with a new risk-sharing partnership.
2006 – 2009
GENFIT continues its growth and accelerates the development of its drug candidates.
- GENFIT is listed on the Alternext market of NYSE Euronext Paris (ALGFT).
- Clinical data confirm the safety and the therapeutic potential of elafibranor (GFT505) in diabetes complications.
2003 – 2005
1999 – 2002
Since its inception, GENFIT collaborates with many players in the pharmaceutical world for our expertise in gene regulation and functional genomics.
- Creation of Genfit and installation in modern laboratories in Lille, France.
- Research alliances with Sanofi Aventis , Merck, UCB Pharma, Solvay / Abbott, Pierre Fabre, Kowa.