Drugs / Elafibranor
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary biliary cholangitis 3 3 milestones | |||||
| Filed | EU (EMA) | — | primary biliary cholangitis 3 | 2023-12-07 | “new drug application filing with the FDA and the filing of the marketing authorization application with the EMA for the accelerated approval of elafibranor” genfit.com ↗ “The European Medicines Agency (EMA) has also validated Ipsen’s Marketing Authorization Application (MAA) for elafibranor” genfit.com ↗ |
| Filed | UK (MHRA) | — | primary biliary cholangitis 3 | 2023-12-07 | “a third simultaneous regulatory filing of elafibranor has been validated for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).” genfit.com ↗ |
| Filed | US (FDA) | — | primary biliary cholangitis 3 | 2023-12-07 | “new drug application filing with the FDA and the filing of the marketing authorization application with the EMA for the accelerated approval of elafibranor” genfit.com ↗ “today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor.” genfit.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved · conditional | EU (EMA) | Iqirvo | — | 2024-09-19 | europa.eu ↗ |
| Approved | US (FDA) | IQIRVO | — | 2024-06-10 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT05564208 | Oct → Dec 2022 | — | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT05543369 | Sep 2022 → Mar 2023 | — | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT04171752 | Nov 2019 → Mar 2020 | — | Genfit | Completed | No outcome recorded |
| Phase 1 | NCT03985969 | Sep 2019 → Mar 2020 | — | Genfit | Completed | No outcome recorded |
| Phase 1 | NCT03844555 | Feb 2019 → Mar 2020 | impaired renal function disease | Genfit | Completed | No outcome recorded |
| Phase 1 | NCT03765671 | Dec 2018 → Jun 2019 | liver disorder | Genfit | Completed | No outcome recorded |
| Phase 1 | NCT02142127 | Apr → Jun 2014 | — | Genfit | Completed | No outcome recorded |
| Phase 1 | NCT02091310 | Feb → Dec 2014 | — | Genfit | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT05627362 | Dec 2022 → Sep 2031 expected | primary sclerosing cholangitis | Ipsen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03953456 | Aug 2019 → Mar 2020 | NAFLD1 | Genfit | Terminated | No outcome recorded |
| Phase 2 | NCT03883607 | Jun 2019 → Jun 2020 | metabolic dysfunction-associated steatohepatitis | Genfit | Terminated | No outcome recorded |
| Phase 2 | NCT01694849 | Sep 2012 → Feb 2015 | metabolic dysfunction-associated steatohepatitis | Genfit | Completed | Missed primary |
| Phase 2 | NCT01271777 | Jan → Nov 2011 | — | Genfit | Completed | Met primary |
| Phase 2 | NCT01261494 | Dec 2010 → Jun 2011 | type 2 diabetes mellitus | Genfit | Completed | No outcome recorded |
| Phase 2 | NCT01275469 | Jun → Dec 2009 | abdominal obesity-metabolic syndrome, glucose intolerance | Genfit | Completed | Missed primary |
| Phase 2 | NCT01271751 | Jan → Sep 2009 | abdominal obesity-metabolic syndrome, syndromic dyslipidemia | Genfit | Completed | Met primary |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07387549 | May 2026 → Apr 2031 expected | primary sclerosing cholangitis | Ipsen | Recruiting | No outcome recorded |
| Phase 3 | NCT06730061 | Jan 2025 → Dec 2026 expected | primary biliary cholangitis | Ipsen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06383403 | Jul 2024 → Jun 2026 | primary biliary cholangitis | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT06016842 | Aug 2023 → May 2029 expected | primary biliary cholangitis | Ipsen | Recruiting | No outcome recorded |
| Phase 3 | NCT04526665 | Sep 2020 → Jun 2023 overdue | primary biliary cholangitis | Ipsen | Active not recruiting | Met primary |
| Phase 3 | NCT02704403 | Mar 2016 → Oct 2020 | metabolic dysfunction-associated steatohepatitis | Genfit | Terminated | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01474161 Comparator | Nov 2011 → Nov 2012 | cardiovascular disorder, hyperlipidemia, obesity disorder, type 2 diabetes mellitus | Genfit | Completed | No outcome recorded |
| Phase 2 | NCT03124108 Comparator | Apr 2017 → Oct 2018 | primary biliary cholangitis | Genfit | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 44
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Ipsen | Results IQIRVO® demonstrates statistically significant improvement in ALP normalization in patients with PBC in Phase IIIb ELSPIRE study ipsen.com ↗
The primary endpoint of ALP normalization was achieved in 85% of patients treated with IQIRVO® (elafibranor) vs 23% on placebo |
| 2026-05-28 | Ipsen | Results New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC ipsen.com ↗
In a post hoc analysis of the pivotal ELATIVE study, shared in a late-breaking presentation, patients with moderate-to-severe fatigue at baseline experienced greater fatigue reductions with IQIRVO compared to placebo across 52 weeks. |
| 2026-05-15 | Ipsen | Results Late-breaking data from EASL reinforces IQIRVO’s impact on ALP reduction with fatigue and pruritus improvement in patients with PBC ipsen.com ↗
Additionally, Ipsen will present interim real-world data from the ELFINITY® Phase IV study confirming real-world effectiveness of IQIRVO in both biochemical outcomes and symptom control, including fatigue and pruritus, with a favorable safety profile. |
| 2025-11-07 | Ipsen | Results Ipsen to present two late-breaking sessions at AASLD on new PBC data supporting IQIRVO®’s long-term efficacy, safety and mechanistic insights in fatigue ipsen.com ↗
At week 182, 72% of patients receiving IQIRVO maintained a biochemical response, with a 47% reduction in alkaline phosphatase (ALP) from baseline. |
| 2025-05-20 | Genfit | Regulatory GENFIT to receive a €26.5 million milestone payment following the approval of pricing and reimbursement of Ipsen’s Iqirvo® in Italy genfit.com ↗
GENFIT (Nasdaq and Euronext: GNFT) , a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that Ipsen’s Iqirvo® 1 has been granted pricing and reimbursement in Italy for Primary Biliary Cholangitis (PBC). |
| 2025-05-07 | Ipsen | Results Late-breaking exploratory data highlights the impact of IQIRVO® (elafibranor) on fatigue and provides mechanistic insights into anti-inflammatory and symptom-related effects in patients with primary biliary cholangitis ipsen.com ↗
Among patients with moderate-to-severe fatigue at baseline, more than twice as many patients treated with IQIRVO (66.7%) achieved clinically meaningful improvements compared to placebo (31.3%). |
| 2025-05-05 | Genfit | Results GENFIT to Present Latest ACLF Research at EASL Congress 2025 genfit.com ↗
Ipsen will be presenting data from its late-breaking abstract on elafibranor, highlighting favorable safety profile and significant efficacy in Primary Sclerosing Cholangitis (PSC) on May 10, 2025 at 11.15 CET. |
| 2025-04-28 | Genfit | Results GENFIT: positive late-breaking Phase 2 data for elafibranor in Primary Sclerosing Cholangitis (PSC) to be presented by Ipsen at EASL Congress 2025 genfit.com ↗
Additionally, patients on elafibranor 120 mg experienced improvements in pruritus compared with patients on placebo according to the Worst Itch Numeric Rating Scale (WI NRS) score (-0.96 vs -0.28; p<0.05). |
| 2025-04-24 | Ipsen | Results Late-breaking elafibranor primary sclerosing cholangitis (PSC) data demonstrates favorable safety profile and significant efficacy in second potential rare liver disease indication ipsen.com ↗
The Phase II ELMWOOD trial data (LB25222/OS089) demonstrated a positive safety and tolerability profile and efficacy benefits for patients with PSC treated with elafibranor versus those treated with a placebo. |
| 2024-11-15 | Ipsen | Results Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus ipsen.com ↗
The late-breaking presentations (Abstract #5041 and Abstract #5042) report on biomarkers of cholestasis, stabilization of surrogate markers of liver fibrosis and moderate-to-severe pruritus data for up to three years in Iqirvo-treated patients. |
| 2024-09-23 | Genfit | Regulatory GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval genfit.com ↗ |
| 2024-09-20 | Ipsen | Regulatory Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade ipsen.com ↗
European Commission grants conditional marketing authorization for Iqirvo® (elafibranor), first-in-class new treatment for primary biliary cholangitis (PBC), a rare liver disease |
| 2024-07-26 | Ipsen | Regulatory Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases ipsen.com ↗
Iqirvo® (elafibranor) has been recommended for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. |
| 2024-07-26 | Genfit | Regulatory GENFIT: Positive Opinion from EMA Committee for Ipsen’s Iqirvo® (elafibranor) in Primary Biliary Cholangitis genfit.com ↗ |
| 2024-06-10 | Ipsen | Regulatory Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis ipsen.com ↗ |
| 2024-06-10 | Genfit | Regulatory GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis genfit.com ↗
This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). |
| 2024-06-05 | Ipsen | Results Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced new late-breaking data at the European Association for the Study of the Liver (EASL) Congress demonstrating the enduring efficacy of elafibranor in managing disease progression after 78 weeks of treatment. |
| 2023-12-07 | Ipsen | Regulatory Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. |
| 2023-12-07 | Genfit | Regulatory Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC genfit.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. |
| 2023-11-13 | Ipsen | Results Results from Ipsen’s ELATIVE® pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and published in New England Journal of Medicine ipsen.com ↗
Elafibranor demonstrates significant improvements in biomarkers of disease progression versus placebo, including significant treatment benefit with improvement in biochemical response and alkaline phosphatase (ALP) normalization, along with patient-reported outcomes data suggesting a possible improvement in pruritus. |
| 2023-11-13 | Genfit | Results GENFIT: Results from Ipsen’s ELATIVE® pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and published in New England Journal of Medicine genfit.com ↗
Only patients receiving elafibranor achieved normalization of ALP (upper limit of normal 104 U/L in females and 129 U/L in males) at Week 52 (15% vs 0% placebo, P=0.002), a key secondary endpoint of the trial. |
| 2023-06-30 | Ipsen | Results Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE trial of elafibranor in patients with primary biliary cholangitis, a rare cholestatic liver disease ipsen.com ↗
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg achieving a cholestasis response compared with 4% on placebo (p<0.0001). |
| 2023-06-30 | Genfit | Results Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE® trial of elafibranor in patients with primary biliary cholangitis, a rare cholestatic liver disease genfit.com ↗
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg achieving a cholestasis response compared with 4% on placebo (p<0.0001). |
| 2021-11-02 | Genfit | Results New Clinical Data on GENFIT’s Investigational Compound Elafibranor to be Presented at AASLD The Liver Meeting® genfit.com ↗
Elafibranor was generally safe and well tolerated in this study, which is in keeping with previously conducted studies. |
| 2021-02-09 | Genfit | Results GENFIT Announces Publication of Positive Results from the Phase 2 Clinical Trial Evaluating Elafibranor in Patients with PBC in the Journal of Hepatology genfit.com ↗ |
| 2020-08-26 | Genfit | Results GENFIT Announces Two Oral Presentations at the Digital International Liver Congress™ 2020 genfit.com ↗
The second presentation will discuss the positive, pre-clinical data of GENFIT’s lead compound, elafibranor, in combination with semaglutide, in reducing liver inflammation. |
| 2020-07-22 | Genfit | Results GENFIT: Provides Initial Update on Corporate Strategy genfit.com ↗
today announced the discontinuation of the RESOLVE-IT Phase 3 clinical trial of elafibranor in adults with non-alcoholic steatohepatitis (NASH) and fibrosis. |
| 2020-05-11 | Genfit | Results GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH and Fibrosis genfit.com ↗
The trial did not meet the predefined primary endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients. |
| 2019-11-26 | Genfit | Results GENFIT: Positive 42-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH genfit.com ↗
GENFIT (Euronext: GNFT – Nasdaq: GNFT) a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the Data Safety Monitoring Board (DSMB) issued a positive recommendation for the continuation, without any modifications, of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH. |
| 2019-10-31 | Genfit | Results GENFIT Announces New Data to be Presented at AASLD Liver Meeting 2019 genfit.com ↗
In addition, two posters will be presented demonstrating synergistic efficacy of elafibranor in combination with nitazoxanide (NTZ) and in combination with semaglutide. |
| 2019-07-29 | Genfit | Regulatory FDA and EMA Grant GENFIT’s Elafibranor Orphan Drug Designation for Primary Biliary Cholangitis (PBC) genfit.com ↗
GENFIT (Nasdaq and Euronext: GNFT) , a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted Orphan Drug Designation to elafibranor, a PPAR alpha/delta agonist, for the treatment of PBC. |
| 2019-04-18 | Genfit | Regulatory GENFIT announces FDA Grant of Breakthrough Therapy Designation to Elafibranor for the Treatment of PBC genfit.com ↗
GENFIT (Nasdaq and Euronext: GNFT – ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that its lead product candidate elafibranor was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid (UDCA). |
| 2019-04-04 | Genfit | Results GENFIT announces Upcoming Presentations on NASH, PBC and Diagnostics at the European Association for the Study of the Liver (EASL) International Liver Congress 2019 genfit.com ↗
We are pleased that EASL has granted GENFIT a late-breaker oral presentation, providing the first opportunity for us to present the full, positive Phase 2 data for elafibranor in PBC. |
| 2019-03-11 | Genfit | Regulatory GENFIT announces FDA Protocol Clearance for Phase 2 Clinical Trial of Elafibranor in Pediatric NASH genfit.com ↗
GENFIT (Euronext: GNFT – ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced protocol clearance by the FDA for a Phase 2 trial evaluating elafibranor in children and adolescents with non-alcoholic steatohepatitis (NASH). |
| 2018-12-06 | Genfit | Results GENFIT: Positive Phase 2 Results from Study of Elafibranor in Primary Biliary Cholangitis genfit.com ↗
today announced positive results from its Phase 2 study of elafibranor in patients with primary biliary cholangitis (PBC), a chronic liver disease. |
| 2018-06-27 | Genfit | Results GENFIT: New Preclinical Data Shows Elafibranor Inhibits Development of NAFLD/NASH-Related Cancer genfit.com ↗
The number of neoplastic nodules that developed in mice exposed for several months to a NASH-inducing diet was significantly attenuated in mice that received elafibranor. |
| 2018-04-23 | Genfit | Results GENFIT: Positive Outcome from the 24-month Pre-Planned Safety Review by the DSMB, in RESOLVE-IT Phase 3 Clinical Trial with Elafibranor genfit.com ↗
GENFIT (Euronext: GNFT – ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH without any modifications. |
| 2018-03-28 | Genfit | Results GENFIT: Presentations at EASL 2018 Annual Congress Highlight Progress in NASH Diagnostics, Combination Therapies and Deep-learning Applications in Medical Imaging genfit.com ↗
In this study, NTZ complements low dose elafibranor to reduce fibrosis in a preclinical NASH model. |
| 2017-06-01 | Genfit | Results GENFIT: Positive Outcome from the 1-year Pre-Planned Safety Review by the DSMB, in RESOLVE-IT Phase 3 Clinical Trial with Elafibranor genfit.com ↗
Safety data, including adverse events and laboratory data, were reviewed by the Data Safety Monitoring Board (DSMB) which recommended the continuation of the trial without any modifications |
| 2016-11-14 | Genfit | Regulatory GENFIT Initiates Paediatric NAFLD/NASH Program in Europe Further to the Approval of elafibranor’s Paediatric Investigation Plan by the EMA genfit.com ↗
This key step follows the approval by the European Medicine Agency (EMA) of elafibranor’s Pediatric Investigation Plan (PIP). |
| 2016-11-04 | Genfit | Regulatory GENFIT: FDA has officially cleared the IND to proceed with Phase II trial and evaluate elafibranor in PBC genfit.com ↗
Investigational New Drug (IND) application cleared by the FDA for the new indication of elafibranor in Primary Biliary Cholangitis (PBC), a rare disease with unmet need and only two orphan products approved to date. |
| 2016-09-27 | Genfit | Regulatory GENFIT is Filing for IND Submission for New Indication of Elafibranor in Primary Biliary Cholangitis (PBC) genfit.com ↗
GENFIT (Euronext: GNFT – ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced that it is filing an IND submission for a Phase 2 trial in Primary Biliary Cholangitis (PBC), aimed at evaluating decrease in alkaline phosphatase (ALP) with elafibranor vs placebo. |
| 2016-02-11 | Genfit | Results Data from Phase 2b trial of GENFIT’s Elafibranor published in Gastroenterology genfit.com ↗
today announces that detailed results from the Phase 2b clinical trial evaluating GFT505 in NASH, the company’s investigational once-daily oral drug (first-in-class), have been published online in Gastroenterology, in advance of appearing in print in the May isssue. |
| 2014-01-29 | Genfit | Results Preclinical data support anti-cancer effects of GFT505 genfit.com ↗ |
All press releases naming this drug 60 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elafibranor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05627362 ↗ |
| Known as | GFT505 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02091310 ↗ |
| Known as | Iqirvo | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707395 ↗ |
| Action | Activate | “a novel dual peroxisome proliferator-activated receptor alpha/delta (PPAR-α/δ) agonist” PMID 23703580 ↗ Oct 20132“Peroxisome proliferator-activated receptor alpha agonist” CHEMBL3707395 ↗ “Peroxisome proliferator-activated receptor delta agonist” CHEMBL3707395 ↗ |
| Modality | Small molecule | — CHEMBL3707395 ↗ |
| Route | Oral | “oral administration” NCT01261494 ↗ |
| Target | PPARA | “Peroxisome proliferator-activated receptor alpha agonist” CHEMBL3707395 ↗ |
| Target | PPARD | “Peroxisome proliferator-activated receptor delta agonist” CHEMBL3707395 ↗ |