Drugs / Elafibranor
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Iqirvo | — | 2024-09-19 | europa.eu ↗ |
| Approved | US (FDA) | IQIRVO | — | 2024-06-10 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT01271777 | Jan → Nov 2011 | — | Genfit | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01271751 | Jan → Sep 2009 | abdominal obesity-metabolic syndrome, syndromic dyslipidemia | Genfit | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02704403 | Mar 2016 → Oct 2020 | metabolic dysfunction-associated steatohepatitis | Genfit | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01474161 Comparator | Nov 2011 → Nov 2012 | cardiovascular disorder, hyperlipidemia, obesity disorder, type 2 diabetes mellitus | Genfit | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03124108 Comparator | Apr 2017 → Oct 2018 | primary biliary cholangitis | Genfit | Completed | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Ipsen | IQIRVO® demonstrates statistically significant improvement in ALP normalization in patients with PBC in Phase IIIb ELSPIRE study ipsen.com ↗ |
| 2026-05-28 | Ipsen | New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC ipsen.com ↗ |
| 2026-05-15 | Ipsen | Late-breaking data from EASL reinforces IQIRVO’s impact on ALP reduction with fatigue and pruritus improvement in patients with PBC ipsen.com ↗ |
| 2025-11-07 | Ipsen | 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 ↗ |
| 2025-05-07 | Ipsen | 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 ↗ |
| 2025-04-24 | Ipsen | Late-breaking elafibranor primary sclerosing cholangitis (PSC) data demonstrates favorable safety profile and significant efficacy in second potential rare liver disease indication ipsen.com ↗ |
| 2024-11-15 | Ipsen | Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus ipsen.com ↗ |
| 2024-09-20 | Ipsen | Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade ipsen.com ↗ |
| 2024-07-26 | Ipsen | 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 ↗ |
| 2024-06-10 | Ipsen | Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis ipsen.com ↗ |
| 2024-06-05 | Ipsen | Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis ipsen.com ↗ |
| 2023-12-07 | Ipsen | 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 ↗ |
| 2023-11-13 | Ipsen | 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 ↗ |
| 2023-06-30 | Ipsen | 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 ↗ |
| 2021-12-17 | Ipsen | Ipsen and GENFIT enter into exclusive licensing agreement for elafibranor, a Phase III asset evaluated in Primary Biliary Cholangitis, as part of a long-term global partnership ipsen.com ↗ |
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 NCT03985969 ↗ |
| 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 ↗ |