GENFIT: FDA Grants Key Designation to Its Candidate for Cirrhosis
GENFIT announces that the U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to G1090N (nitazoxanide), its experimental candidate for the treatment of acute decompensation in cirrhosis. This recognition of therapeutic potential paves the way for progression to phase 2 clinical trials.
FDA Approval for Orphan Drug Designation
The FDA has granted ODD to G1090N, GENFIT's most advanced program in the segment of acute decompensation in cirrhosis (ACLF). This designation recognizes the potential of the active substance to treat this rare disease characterized by rapid deterioration in patient condition, systemic inflammation, and high short-term mortality. The ODD follows recent phase 1 results demonstrating a favorable safety and tolerability profile in healthy volunteers, as well as data regarding anti-inflammatory activity observed in ex vivo models.
Regulatory and Financial Advantages of ODD
The ODD designation provides GENFIT with FDA regulatory support, certain administrative fee reductions, and eligibility for seven years of market exclusivity in the United States for this indication if approved. These benefits create a solid foundation for advancing the program towards the initiation of a phase 2 clinical trial, scheduled for the second half of 2026.
