Pronunciation: elle-a-fib-ran-or
Generic name: elafibranor
Brand name: Iqirvo
Dosage form: oral tablet (80 mg)
Drug class: Miscellaneous metabolic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 17, 2025.

What is Elafibranor (Iqirvo)? PBC Treatment

Elafibranor (Iqirvo) is an FDA-approved medication for treating primary biliary cholangitis (PBC), a rare chronic liver disease that damages bile ducts in adults. This oral PBC treatment can be prescribed as combination therapy with ursodeoxycholic acid (UDCA) for patients with an inadequate UDCA response, or as monotherapy for those with UDCA intolerance. Once-daily elafibranor therapy helps reduce elevated alkaline phosphatase (ALP) levels and may normalize liver enzymes in PBC patients.

Key Facts About Elafibranor

• Generic name: elafibranor
• Brand name: Iqirvo
• Manufacturer: Ipsen Biopharmaceuticals, Inc.
• FDA approval date: June 10, 2024
• Drug class: PPAR agonist (peroxisome proliferator-activated receptor agonist)
• Dosage form: 80 mg oral tablet, taken once daily

Primary Biliary Cholangitis Treatment: How Elafibranor Works

Mechanism of Action

Elafibranor is a dual PPAR-alpha and PPAR-delta receptor agonist. This unique mechanism helps:

• Reduce liver inflammation
• Improve bile acid metabolism
• Decrease bile acid toxicity
• Regulate lipid and glucose metabolism
• Support mitochondrial fatty acid metabolism
• Combat oxidative stress.

Clinical Effectiveness

Clinical trials demonstrate that patients treated with elafibranor experience:

• Significant reduction in alkaline phosphatase (ALP) levels within 4 weeks
• Sustained improvements maintained through 52 weeks of treatment
• Better liver function markers compared to standard treatment alone.

Who Can Take Elafibranor? Indications and Patient Selection

FDA-Approved Uses

Elafibranor is indicated for adults with primary biliary cholangitis in two scenarios:

• Combination therapy: Used with ursodeoxycholic acid (UDCA) in patients with inadequate response to UDCA alone
• Monotherapy: Used alone in patients who cannot tolerate UDCA treatment.

Patient Eligibility Requirements

• Adults 18 years and older
• Confirmed diagnosis of primary biliary cholangitis
• Either an inadequate response to UDCA or UDCA intolerance
• No signs of advanced liver disease (decompensated cirrhosis).

Elafibranor Side Effects: What to Expect

Common Side Effects (Most Frequent)

• Weight gain or weight loss
• Gastrointestinal issues (diarrhea, nausea, vomiting, constipation)
• Abdominal/stomach pain
• Joint pain (arthralgia)
• Muscle problems
• Bone fractures
• Gastroesophageal reflux disease (GERD)
• Dry mouth
• Rash.

Serious Side Effects Requiring Immediate Medical Attention

Muscle Problems (Myopathy/Rhabdomyolysis)

Treatment with elafibranor may cause muscle pain or worsen existing pain and can increase the level of an enzyme in your blood called creatine phosphokinase (CPK). Your healthcare provider should test for muscle weakness or pain before and during treatment. Stop taking elafibranor and call your healthcare provider right away if you have any of the following warning signs:

• Severe muscle pain or weakness
• Unexplained muscle soreness
• Dark, reddish urine
• Elevated creatine phosphokinase (CPK) levels.

Liver Complications

Elafibranor may cause abnormal liver blood test results. Your healthcare provider should do tests before starting and during treatment with elafibranor to check your liver function. Seek emergency care if experiencing:

• Abdominal swelling from fluid buildup 
• Yellowing of skin or eyes (jaundice)
• Black, tarry, or bloody stools
• Coffee-ground appearance of vomit
• Mental changes, confusion, or mood swings.

Your healthcare provider may tell you to stop taking elafibranor temporarily or permanently if there are changes in your liver function tests. 

Bone Health Issues

Taking elafibranor may increase your risk of bone fractures. Tell your healthcare provider if you have:

• New bone pain
• Mobility changes
• A fracture. 

Bile Duct Blockage

Taking elafibranor may increase your risk of gallstones. Call your healthcare provider right away if you develop:

• Pain in the upper right stomach area
• Yellowing of the skin.

Allergic Reactions

These have occurred in some people taking elafibranor, and symptoms may appear 2 to 30 days after starting treatment. Seek urgent medical attention if you develop:

• A skin rash or itching
• Difficulty breathing
• Swelling of the face, lips, tongue, or throat.

Pregnancy Harm

Elafibranor may harm an unborn baby. If you are a female who can become pregnant, your healthcare provider may conduct a pregnancy test before prescribing elafibranor. You should use effective birth control during treatment and for 3 weeks after the last dose of elafibranor.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Absolute Contraindications

Do not use elafibranor if you have:

• Advanced liver disease (decompensated cirrhosis)
• Signs of liver decompensation, such as:
  • Confusion or mental changes
  • Abdominal fluid accumulation
  • Gastrointestinal bleeding
  • Coffee-ground vomiting.

Pregnancy and Breastfeeding Considerations

Pregnancy Safety

• Pregnancy Category: Can harm unborn babies
• Required precautions: Effective birth control during treatment and 3 weeks after last dose
• Pregnancy testing: May be required before starting treatment
• Pregnancy registry: Available at 1-855-463-5217 or ipsen.com/contact-us

Breastfeeding Guidelines

• Not recommended: Avoid breastfeeding during treatment
• Duration: Continue avoiding for 3 weeks after the final dose
• Alternative feeding: Discuss safe infant feeding options with a healthcare provider

How is elafibranor administered?

Take elafibranor exactly as your healthcare provider tells you to.

• Elafibranor is taken once a day. 
• Can be taken with or without food.

Important Timing Considerations

If taking bile acid binding resins (cholestyramine, colestipol):

• Take elafibranor at least 4 hours before OR 4 hours after the bile acid sequestrant
• Space medications as far apart as possible if a 4-hour separation isn't feasible.

Ongoing Monitoring

Healthcare providers will regularly check:

• Liver enzymes: ALT, AST, alkaline phosphatase, bilirubin
• Muscle markers: Creatine phosphokinase (CPK) levels
• Clinical symptoms: Muscle pain, weakness, liver-related symptoms
• Treatment response: ALP reduction and overall liver function improvement.

Elafibranor Dosage and Administration Guidelines for PBC

Standard Dosing

• Adult dose: 80 mg once daily
• Administration: Can be taken with or without food
• Duration: Long-term treatment as prescribed by your healthcare provider.

Missed Dose Instructions

• Take the missed dose as soon as you remember
• Skip the missed dose if almost time for the next scheduled dose
• Never double-dose to make up for the missed medication.

What happens if I overdose?

If you take too much elafibranor, call your healthcare provider or get emergency medical help right away.

What other drugs will affect elafibranor?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Elafibranor can affect the way certain medicines work. Especially tell your healthcare provider if you take:

• Hormonal contraceptives (birth control pills). You will need to switch to effective non-hormonal birth control methods or add a barrier method when using hormonal contraceptives. Continue these precautions for 3 weeks after stopping elafibranor.
• HMG-CoA reductase inhibitors (statins, such as atorvastatin, pravastatin, or lipostatin). There is an increased risk of muscle injury if you combine statins with elafibranor. Regular monitoring for muscle symptoms is required.
• Rifampin. Your healthcare provider will need to monitor your liver function (alkaline phosphotase and bilirubin) if you are also taking rifampin. 
• Bile acid binding resins, such as cholestyramine or colestipol. Elafibranor should be taken at least 4 hours before or 4 hours after a bile acid-binding sequestrant, or at as great an interval as possible.

This is not a complete list of interactions. Talk to your healthcare provider or see the Iqirvo (elafibranor) Package Insert for a full list.

Storage

• Store at room temperature between 15°C to 30°C (59°F to 86°F).
• Keep in the original package (bottle and carton) to protect from moisture and light.
• Keep out of the reach of children.

Ingredients

Elafibranor is only available as the brand Iqirvo.

Active ingredient: elafibranor

Inactive ingredients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone.

Film coating: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Available as 80 mg tablets.

Manufacturer

Elafibranor is manufactured by Ipsen Biopharmaceuticals, Inc., under the brand name Iqirvo. Their global headquarters are in Paris, France.

Frequently Asked Questions About Elafibranor

How quickly does elafibranor work?

Clinical improvements in alkaline phosphatase levels typically occur within 4 weeks of starting treatment.

Can I take elafibranor with food?

Yes, elafibranor can be taken with or without food.

What should I do if I experience muscle pain?

Contact your healthcare provider immediately if you develop new or severe muscle pain, weakness, or dark urine.

Is elafibranor safe for long-term use?

Clinical studies support long-term use, but regular monitoring by your healthcare provider is essential.

Can I stop taking elafibranor suddenly?

Consult your healthcare provider before stopping elafibranor. Sudden discontinuation may affect your liver condition management.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer