GENFIT (GNFT) FDA Approvals

GENFIT's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by GENFIT (GNFT). Over the past two years, GENFIT has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as elafibranor and VS-01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Elafibranor FDA Regulatory Events

Elafibranor is a drug developed by GENFIT for the following indication: for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

New Data - November 7,2025

• Drug: elafibranor
• Announced Date: November 7, 2025
• Indication: for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).

Announcement

Ipsen announced that new Primary Biliary Cholangitis (PBC) data with IQIRVO® from the ELATIVE trial1, 2 will be presented in two late-breaking sessions, at The Liver Meeting® 2025, hosted by the American Association for the Study of Liver Diseases (AASLD).

AI Summary

Ipsen announced that new Primary Biliary Cholangitis (PBC) data for IQIRVO® (elafibranor) from the ELATIVE trial will be presented in two late‑breaking sessions at The Liver Meeting® 2025, hosted by AASLD. The sessions will cover long‑term clinical findings and a proteomic analysis linking protein changes to fatigue outcomes.

Interim results from the open‑label extension, with more than three years of follow‑up in 115 patients, showed sustained biochemical responses and stabilization of fibrosis markers. At week 182, 72% of patients maintained a biochemical response and alkaline phosphatase (ALP) fell 47% from baseline. The share of patients reaching normal ALP stayed consistent with prior phase III findings, and no new safety signals were reported.

A separate analysis found changes in fatigue‑associated proteins that correlated with reported improvements in fatigue, suggesting IQIRVO’s PPAR α/δ activity may affect energy‑ and mitochondrial‑related pathways. These findings support further research into IQIRVO’s potential to relieve symptoms and slow disease progression in PBC.

FDA Approval - June 10,2024

• Drug: elafibranor
• Announced Date: June 10, 2024
• Indication: for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).

Announcement

Ipsen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo may be prescribed immediately in the U.S. for eligible patients.

AI Summary

The U.S. FDA has granted accelerated approval for Ipsen’s Iqirvo® (elafibranor) 80 mg tablets to treat primary biliary cholangitis (PBC). Iqirvo is approved for use in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or as a stand-alone treatment for patients who cannot tolerate it. This approval allows doctors to prescribe Iqirvo immediately to eligible patients in the United States, offering a new treatment option for a rare liver disease that affects around 100,000 Americans.

The decision is based on findings from the Phase III ELATIVE trial, where significant improvements in the biochemical marker alkaline phosphatase (ALP) were observed. Although long-term outcomes like improved survival have not yet been confirmed, this accelerated approval meets an urgent need for PBC patients who previously had few effective treatment choices.

VS-01 FDA Regulatory Events

VS-01 is a drug developed by GENFIT for the following indication: in ACLF (Acute-on-Chronic Liver Failure). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Discontinue - September 19,2025

• Drug: VS-01
• Announced Date: September 19, 2025
• Indication: in ACLF (Acute-on-Chronic Liver Failure)

Announcement

GENFIT announced its decision to discontinue its VS-01 program in ACLF (Acute-on-Chronic Liver Failure), and reprioritize the development of VS-01 on UCD (Urea Cycle Disorder).

GENFIT FDA Events - Frequently Asked Questions

Has GENFIT received FDA approval?

In the past two years, GENFIT (GNFT) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

What drugs has GENFIT submitted to the FDA?

In the past two years, GENFIT (GNFT) has reported FDA regulatory activity for the following drugs: elafibranor and VS-01.

What is the most recent FDA event for GENFIT?

The most recent FDA-related event for GENFIT occurred on November 7, 2025, involving elafibranor. The update was categorized as "New Data," with the company reporting: "Ipsen announced that new Primary Biliary Cholangitis (PBC) data with IQIRVO® from the ELATIVE trial1, 2 will be presented in two late-breaking sessions, at The Liver Meeting® 2025, hosted by the American Association for the Study of Liver Diseases (AASLD)."

What conditions do GENFIT's current drugs treat?

Current therapies from GENFIT in review with the FDA target conditions such as:

• for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA). - elafibranor
• in ACLF (Acute-on-Chronic Liver Failure) - VS-01