Clinical Trials

Multiple clinical trials, primarily sponsored by Genfit and Ipsen, evaluate the clinical profile and pharmacokinetics of elafibranor across Phase 1 through Phase 3 studies. These investigations focus on healthy volunteers as well as patients with liver and metabolic conditions, including Primary Biliary Cholangitis (PBC), Non-Alcoholic Steatohepatitis (NASH), primary sclerosing cholangitis, and renal impairment. Protocol recruitment statuses across these studies include completed, terminated, recruiting, and active, non-recruiting trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05627362 ACTIVE_NOT_RECRUITING
Primary Sclerosing Cholangitis
Ipsen
 2022-12-29 PHASE2
NCT07387549 RECRUITING
Primary Sclerosing Cholangitis
Ipsen
 2026-05-14 PHASE3
NCT06016842 RECRUITING
Primary Biliary Cholangitis (PBC)
Ipsen
 2023-08-31 PHASE3
NCT06730061 ACTIVE_NOT_RECRUITING
Primary Biliary Cholangitis
Ipsen
 2025-01-16 PHASE3
NCT06383403 COMPLETED
Primary Biliary Cholangitis
Ipsen
 2024-07-09 PHASE3
NCT04526665 ACTIVE_NOT_RECRUITING
Primary Biliary Cirrhosis
Ipsen
 2020-09-24 PHASE3
NCT05543369 COMPLETED
Healthy Volunteers
Ipsen
 2022-09-19 PHASE1
NCT05564208 COMPLETED
Healthy Participants
Ipsen
 2022-10-27 PHASE1
NCT05564208 Completed
Healthy Participants
Ipsen
 2022-10-27 Phase 1
NCT05543369 Completed
Healthy Volunteers
Ipsen
 2022-09-19 Phase 1
NCT02704403 TERMINATED
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Genfit
 2016-03 PHASE3
NCT03883607 TERMINATED
Non Alcoholic Steatohepatitis
Genfit
 2019-06-25 PHASE2
NCT04171752 COMPLETED
Geriatrics; Healthy
Genfit
 2019-11-22 PHASE1
NCT03985969 COMPLETED
Drug-drug Interaction
Genfit
 2019-09-23 PHASE1
NCT03844555 COMPLETED
Renal Impairment; Renal Insufficiency; Kidney Diseases; Pharmacokinetics
Genfit
 2019-02-28 PHASE1
NCT03953456 TERMINATED
Non-Alcoholic Fatty Liver
Genfit
 2019-08-16 PHASE2
NCT04171752 Completed
Geriatrics|Healthy
Genfit
 2019-11-22 Phase 1
NCT03765671 COMPLETED
Hepatic Impairment; Liver Disease; Pharmacokinetics
Genfit
 2018-12-12 PHASE1
NCT03883607 Terminated
Non Alcoholic Steatohepatitis
Genfit
 2019-06-25 Phase 2
NCT03844555 Completed
Renal Impairment|Renal Insufficiency|Kidney Diseases|Pharmacokinetics
Genfit
 2019-02-28 Phase 1
NCT03124108 COMPLETED
Primary Biliary Cholangitis (PBC)
Genfit
 2017-04-05 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-31)

Check the Elafibranor product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elafibranor functions as a dual agonist of peroxisome proliferator-activated receptor-alpha and peroxisome proliferator-activated receptor-delta, binding these nuclear receptors to stimulate downstream transcriptional activity governing lipid metabolism and inflammatory pathways. By promoting fatty acid oxidation, improving insulin sensitivity, and suppressing pro-inflammatory cascades, elafibranor reduces hepatic tissue injury and inflammation, providing therapeutic efficacy in clinical conditions such as primary biliary cholangitis and non-alcoholic steatohepatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.