Significant and encouraging clinical trial news in the field of primary sclerosing cholangitis (PSC) drug development. The trial sponsor, Ipsen and developer, GENFIT, announced on Feb. 12, 2026, that elafibranor has progressed to a Phase 3 clinical trial for PSC, known as the ELASCOPE study.
Advancing to a Phase 3 trial represents an important milestone in drug development and there have been few Phase 3 trials in PSC. Phase 3 trials are designed to further evaluate the safety and effectiveness of a treatment in a larger group of participants. Typically, phase 3 is the final step before regulatory review, which is the formal evaluation by a government health authority to decide whether a new drug can be approved for marketing and patient use. In Canada, the primary regulator of prescription drugs is Health Canada.
What is elafibranor?
Elafibranor is an investigational medication (or experimental drug) that works by activating two receptors in the body known as PPAR-alpha and PPAR-delta (peroxisome proliferator-activated receptors). These receptors play an important role in regulating inflammation, bile acid metabolism, and fibrosis (scarring).Elafibranor is being studied to determine whether it can help reduce liver injury and slow PSC disease progression.
Previous clinical research in PSC has shown promising signals, leading to the launch of this Phase 3 study.
Recruitment and eligibility
As of February 2026, full recruitment details have not been released. However, the previous Phase 2 study of elafibranor (ELMWOOD) included six Canadian research sites in Alberta, BC, Ontario and Quebec. PSC Partners Seeking a Cure Canada will continue to monitor updates closely and share information about study participation as soon as it becomes available.
Based on currently available information, individuals who may be eligible include:
- Adults aged 18–75
- Diagnosis of large duct PSC
- Compensated liver disease at screening
- On stable background therapy, where applicable, prior to study entry
Individuals who may not be eligible include those with:
- History or presence of another chronic liver disease
- History of hepatic decompensation, including:
- Prior liver transplantation
- Current MELD 3.0 score ≥ 12 due to hepatic impairment
- Evidence of complications of cirrhosis
Please note that final eligibility criteria will be confirmed by study investigators once recruitment begins. Ipsen has released this schematic overview of the study design.
For full study details, please visit the listing on ClinicalTrials.gov under identifier: NCT07387549.
PSC Partners Canada looks forward to sharing additional information about elafibranor as it becomes available and will continue to keep the Canadian PSC community informed about developments in this important clinical trial.
What was learned in the elafibranor phase II trial (ELMWOOD)?
Results of the 12-week Phase 2 study of elafibranor (ELMWOOD) were presented recently at the November 2025 American Association for the Study of Liver Diseases (AASLD) annual meeting (as an abstract) and also in print in the open-access and peer-reviewed article published in January 2025 in the Journal of Hepatology.
At a high level, these publications report that:
- The drug appears safe over several months.
- It improves important liver test markers in PSC.
- Benefits were maintained or increased with continued treatment.
- People who switched from placebo improved after starting the drug.
- There are early signs it might help with liver scarring.
ELMWOOD is a mid-stage trial, and larger Phase 3 studies such as ELASCOPE are needed to confirm whether elafibranor changes long-term outcomes like disease progression or need for transplant.
For further information PSC-related clinical trials in Canada please visit https://pscpartners.ca/clinical-trials/.
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