What Is Elafibranor?
Elafibranor is an investigational medication currently being studied in clinical trials. It is a type of drug that has been explored for its potential role in treating certain liver conditions. While the specific mechanism of how elafibranor works is not detailed in the provided trial descriptions, it is being investigated for its effects on diseases that impact the liver and bile ducts.
Clinical trials are evaluating elafibranor for conditions such as Primary Biliary Cholangitis (PBC), a chronic liver disease that slowly damages the bile ducts in the liver. It is also under investigation for Primary Sclerosing Cholangitis, another chronic disease where inflammation and scarring block the bile ducts. Additionally, elafibranor is being studied for non-alcoholic fatty liver diseases, including Non Alcoholic Steatohepatitis, a more severe form of fatty liver disease characterized by inflammation and liver cell damage. These studies aim to understand how elafibranor might improve liver health and function in patients with these challenging conditions.
Uses and Conditions Under Study
Elafibranor is being investigated across a range of clinical trials for its potential therapeutic benefits, primarily focusing on liver and bile duct diseases. A total of 16 trials have been conducted or are ongoing, involving 3,353 participants.
- Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC): Elafibranor is being studied for these chronic liver diseases that affect the bile ducts. PBC and PSC can lead to inflammation, scarring, and eventual liver damage. Elafibranor is being explored as a potential treatment to slow disease progression or improve symptoms. There are 4 trials specifically for PBC (including "Primary Biliary Cholangitis" and "Primary Biliary Cholangitis (PBC)") and 2 trials for PSC.
- Non-Alcoholic Fatty Liver Disease (NAFLD) and Non Alcoholic Steatohepatitis (NASH): These conditions involve fat accumulation in the liver, with NASH being a more severe form that includes inflammation and liver cell damage. Elafibranor is being investigated for its ability to address the underlying mechanisms of these diseases and potentially improve liver health. These conditions are studied in 2 trials.
- General Liver Disease: One trial broadly investigates elafibranor in patients with liver disease, aiming to understand its effects across different forms of liver impairment.
Beyond specific treatment indications, several trials focus on understanding how elafibranor behaves in the body. These pharmacokinetic (PK) studies examine how the drug is absorbed, distributed, metabolized, and eliminated. Such studies include 2 trials on pharmacokinetics, 1 trial in healthy volunteers, 1 trial in individuals with hepatic impairment, and 1 trial in patients with kidney diseases. These trials help determine appropriate dosing and safety profiles for different patient populations.
The development of elafibranor is supported by sponsors Genfit and Ipsen, each sponsoring 8 trials.
Dosing
Elafibranor has been studied primarily as an oral tablet. Clinical trials have investigated different strengths and administration methods to determine the most effective and safest dose for various conditions and patient populations.
The strengths of elafibranor studied include 80 mg and 120 mg tablets. In some trials, an 80 mg tablet has been administered once daily during double-blind treatment periods. Other studies have explored the 120 mg strength, sometimes used in open-label extension periods or in specific cohorts.
Dosing regimens have also considered how the drug is taken in relation to meals, with studies examining elafibranor administration both in fasting and fed states to understand its absorption characteristics. Specific populations, such as healthy volunteers, young adults, elderly individuals, and those with varying degrees of hepatic (liver) or renal (kidney) impairment (including End Stage Renal Disease, Mild Child-Pugh A, Moderate Child-Pugh B, and Severe Child-Pugh C), have been included in trials to assess how these factors might influence dosing requirements and safety. The precise dosing schedule and strength would be determined by the specific clinical trial protocol for each study.
Side Effects
In clinical trials, the most commonly reported side effect for patients taking Elafibranor was arthralgia (joint pain). The following side effects were reported more frequently in patients taking Elafibranor compared to those on placebo:
- Arthralgia was reported by 11.0% of patients taking Elafibranor, compared to 10.8% on placebo.
- Diarrhea occurred in 10.3% of patients on Elafibranor, compared to 9.6% on placebo.
- Nausea was experienced by 9.9% of patients taking Elafibranor, compared to 6.9% on placebo.
- Nasopharyngitis (common cold) was reported by 9.4% of patients on Elafibranor, compared to 7.3% on placebo.
- Influenza occurred in 7.9% of patients taking Elafibranor, compared to 7.4% on placebo.
- Upper respiratory tract infection was reported by 7.4% of patients on Elafibranor, compared to 6.2% on placebo.
- Headache occurred in 7.1% of patients taking Elafibranor, compared to 6.4% on placebo.
- Bronchitis was reported by 6.4% of patients on Elafibranor, compared to 4.6% on
Currently Recruiting Trials
Elafibranor is currently being investigated in several clinical trials for liver-related conditions. These studies aim to understand how well and safely this investigational medicine works for patients who may have limited treatment options. Participating in a clinical trial offers an opportunity to contribute to medical research and potentially access new treatments.
One active study, NCT07387549, is a Phase 3 trial sponsored by Ipsen. It is designed to assess the effectiveness and safety of Elafibranor 120 mg compared to a placebo in adult participants diagnosed with Primary Sclerosing Cholangitis (PSC). PSC is a rare and progressive disease characterized by inflammation and scarring of the bile ducts in the liver, which can lead to significant liver damage over time. This study is seeking to enroll approximately 350 adult participants.
Another important Phase 3 study, NCT06016842, is a long-term investigation of Elafibranor in adult participants with Primary Biliary Cholangitis (PBC). PBC is a slowly progressive disease where the bile ducts in the liver are damaged, leading to a harmful buildup of bile acids. This study focuses specifically on individuals with confirmed PBC who also have cirrhosis, or scarring of the liver. Sponsored by Ipsen, this trial is evaluating Elafibranor 80 mg and plans to enroll around 276 participants.
Where to Participate
Clinical trials for Elafibranor are accessible across a wide geographic area, with study sites located in 16 states, spanning 33 cities, and totaling 40 sites. This broad reach aims to make participation convenient for a diverse group of patients.
Top participating locations include:
- Dallas, Texas (4 sites)
- Los Angeles, California (3 sites)
- Houston, Texas (2 sites)
- Richmond, Virginia (2 sites)
- San Antonio, Texas (2 sites)
- Colorado Springs, Colorado (1 site)
- Englewood, Colorado (1 site)
- Littleton, Colorado (1 site)
- Miami, Florida (1 site)
- Pembroke Pines, Florida (1 site)
Eligibility for these studies generally requires participants to be between 18 and 75 years of age. All genders are welcome, but these trials are not open to healthy volunteers or children, focusing specifically on patients with the target conditions.
Development Timeline
The journey of Elafibranor in clinical development began on March 10, 2016, marking the start of its first clinical trial. Since then, the compound has progressed through various stages of research, with the latest trial initiated on February 4, 2026. A total of 16 clinical trials have been conducted or are ongoing, involving 3,353 participants.
Early development was primarily driven by Genfit, which sponsored 8 trials, before Ipsen also became a key sponsor, leading another 8 trials. The development pipeline for Elafibranor has expanded significantly over time. Initially, studies focused on conditions such as IBS-C and hyperphosphatemia.
Over the years, the research expanded to investigate Elafibranor for a broader range of liver and kidney-related conditions. These include Primary Biliary Cholangitis (PBC), Primary Biliary Cirrhosis, Non-Alcoholic Fatty Liver, Non Alcoholic Steatohepatitis (NASH) With Fibrosis, Hepatic Impairment, Kidney Diseases, Renal Impairment, and Renal Insufficiency, among others. The trials have progressed through all phases of clinical development, with 6 trials in Phase 1, 4 trials in Phase 2, and 6 trials reaching Phase 3, demonstrating a comprehensive evaluation of Elafibranor's potential.