Clinical Trials
15
15 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1999
Active, not recruiting
15
100.0%
No approval data available
- GENFIT reported €9.6 million in Q1 2026 revenue, a more than threefold increase from €2.8 million in the same period of 2025, driven entirely by royalties from Ipsen's sales of Iqirvo® (elafibranor) for primary biliary cholangitis. - Cash and cash equivalents reached €136.1 million as of March 31, 2026, bolstered by a €17 million commercial milestone payment from Ipsen and a €30 million royalty financing tranche, extending the cash runway beyond 2028. - Nitazoxanide (NTZ/G1090N) received FDA Orphan Drug Designation for acute-on-chronic liver failure (ACLF) in March 2026, with a proof-of-concept study planned for the second half of 2026. - Labcorp's NASHnext® diagnostic test, leveraging GENFIT's non-invasive technology for MASH, is expected to launch commercially in the coming weeks with Medicare and Medicaid having established a pricing framework.
- Ipsen presented late-breaking data at EASL 2026 demonstrating IQIRVO's effectiveness in reducing alkaline phosphatase levels and improving fatigue symptoms in primary biliary cholangitis patients. - Real-world analysis showed 59% of patients with mildly elevated ALP achieved normalization at 6 months, with 72% experiencing significant ALP reduction. - Post-hoc analysis of the ELATIVE Phase III trial revealed 67% of patients with moderate-to-severe fatigue experienced clinically meaningful improvements compared to 31% on placebo. - The ELFINITY Phase IV study confirmed IQIRVO's real-world effectiveness with 55% biochemical response rate and favorable safety profile in routine clinical practice.
- GENFIT will receive a $20 million milestone payment from Ipsen after Iqirvo achieved $208 million in net sales during its first full year on the primary biliary cholangitis market, exceeding the $200 million threshold ahead of schedule. - Ipsen confirmed its commitment to launch a Phase 3 clinical trial for Iqirvo in primary sclerosing cholangitis, representing a significant untapped market opportunity comparable in size to second-line PBC treatment. - GENFIT's oncology program continues to advance with its Phase 1b cholangiocarcinoma study progressing as planned, with a new dose-escalation cohort fully enrolled and no dose-limiting toxicities reported. - The company anticipates 2026 to be a landmark year with expected Phase 1b data readouts and the initiation of Phase 2 studies for G1090N in acute-on-chronic liver failure patients.
- GENFIT reports encouraging Phase 1b data showing GNS561 combined with MEK inhibitor trametinib achieved disease stabilization in all four evaluable patients with advanced KRAS-mutated cholangiocarcinoma. - The combination therapy demonstrated tumor shrinkage in a subset of heavily pretreated patients, with the best response showing a 20% reduction approaching partial response threshold. - No dose-limiting toxicity has been observed to date, enabling recruitment of a third patient cohort and positioning the combination as a potential breakthrough for this difficult-to-treat cancer. - Phase 2 initiation is targeted for the second half of 2026, with recommended Phase 2 doses expected in the first half of 2026.
- GENFIT's investigational drug G1090N demonstrated a favorable safety and tolerability profile in Phase 1 trials with 76 healthy volunteers, supporting continued clinical development for acute-on-chronic liver failure. - Ex vivo studies revealed strong anti-inflammatory activity, with G1090N showing up to 76% statistically significant inhibition of pro-inflammatory cytokines in blood samples from study participants. - The company plans to advance G1090N into Phase 2 proof-of-concept studies after engaging with regulatory authorities including the FDA, targeting a condition with no approved therapies. - ACLF represents a significant unmet medical need affecting patients with chronic liver disease, with GENFIT leading the limited competitive landscape alongside companies like Grifols Therapeutics.
- Interim data from the ELATIVE trial extension shows IQIRVO (elafibranor) maintains biochemical response in 72% of patients at week 182, with a 47% reduction in alkaline phosphatase from baseline over three years of treatment. - New proteomic analysis reveals IQIRVO's PPAR α/δ agonist activity may modulate fatigue-associated pathways linked to mitochondrial function, offering mechanistic insights into symptom improvement. - The drug demonstrates sustained improvements in fatigue and pruritus symptoms alongside stabilization of fibrosis markers, with no new safety signals identified during long-term follow-up. - Primary biliary cholangitis affects approximately 100,000 people in the US and 165,000 in Europe, with fatigue being one of the most burdensome symptoms lacking approved therapies.
- GENFIT will present new preclinical data on three ACLF therapeutic programs at AASLD 2025, including G1090N (nitazoxanide reformulation), SRT-015 (ASK1 inhibitor), and CLM-022 (NLRP3 inflammasome inhibitor). - The company's lead ACLF program G1090N is expected to deliver clinical safety data and early efficacy markers by the end of 2025. - Partner Ipsen will present additional data on Iqirvo (elafibranor) from ongoing studies in primary biliary cholangitis and primary sclerosing cholangitis. - GENFIT will also present real-world evidence studies and biomarker research highlighting diagnostic challenges and patient management issues in ACLF.
- GENFIT has discontinued development of its lead liposomal ammonia scavenger VS-01 for acute-on-chronic liver failure (ACLF) following a peritonitis case reported as a serious adverse event in the Phase II UNVEIL-IT trial. - The company will refocus VS-01 development on urea cycle disorder (UCD), a rare genetic condition with significant unmet medical need, where the drug administration and patient population differ substantially from ACLF. - GENFIT plans to accelerate development of four other ACLF assets (G1090N, SRT-015, CLM-022, and VS-02-HE) based on different mechanisms of action and administration routes. - The discontinuation will require substantial restructuring and operating expense reductions, potentially extending the company's cash runway beyond 2028.
- DelveInsight's 2025 pipeline analysis reveals over 5 companies developing novel therapies for acute-on-chronic liver failure, a condition with high mortality risk requiring urgent medical intervention. - GENFIT discontinued its VS-01 program for ACLF in September 2025 to focus on urea cycle disorders, while the FDA approved eGenesis's EGEN-5784 genetically engineered porcine liver for clinical trials. - HepaRegeniX's first-in-class MKK4 inhibitor HRX-215 demonstrated significant liver regeneration enhancement in preclinical models and showed safety in first-in-human trials. - The pipeline includes diverse therapeutic approaches spanning small molecules, albumin-based treatments, and regenerative therapies across various development stages from preclinical to Phase III.
- GENFIT reported a net profit of €1.5 million for 2024, driven by €67.0 million in revenues including a €48.7 million milestone payment and royalties from Iqirvo® (elafibranor) sales in PBC. - The company secured a transformative non-dilutive royalty financing agreement worth up to €185 million, significantly extending its cash runway beyond 2027. - GENFIT is advancing five complementary programs targeting Acute-on-Chronic Liver Failure (ACLF), with key clinical data readouts expected by the end of 2025.
