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 Apr 28, 2025.

What is elafibranor?

Elafibranor is used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA. It is an oral tablet that is taken once daily.

The brand name of elafibranor is Iqirvo, and it is made by Ipsen Biopharmaceuticals, Inc. There is no generic.

Elafibranor (Iqirvo) gained FDA approval on 10 June 2024 under the accelerated approval designation. Continued approval may be contingent on a positive clinical benefit in reducing alkaline phosphatase (ALP), with no increases in liver toxicity, being found in further clinical trials.

Mechanism

Elafibranor (Iqirvo) is a dual agonist of PPAR-alpha and PPAR-delta receptors. These receptors help regulate lipid and glucose metabolism, mitochondrial fatty acid metabolism, and oxidative stress. Elafibranor works by activating these receptors, reducing inflammation, improving bile acid metabolism, and reducing bile acid toxicity in patients with PBC. 

Clinical trials report that patients treated with elafibranor experienced a greater reduction in mean ALP within 4 weeks of treatment that was generally maintained through week 52.

Elafibranor belongs to the drug class called peroxisome proliferator-activated receptor (PPAR) agonists.

Side effects

The most common side effects of elafibranor are:

• weight gain
• diarrhea
• nausea and vomiting
• joint pain
• stomach pain
• constipation
• muscle problems
• bone fractures
• gastroesophageal reflux disease (GERD)
• dry mouth
• weight loss
• rash.

Serious side effects and warnings

Elafibranor can cause the following serious side effects:

• Muscle problems (such as myalgia, myopathy, or 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), which can be signs of muscle damage. Your healthcare provider should test for muscle weakness or pain before and during treatment. If there is new onset or worsening of muscle pain then your healthcare provider may examine you and perform a blood test to check your levels of creatine phosphokinase (CPK). Stop taking elafibranor and call your healthcare provider right away if you have any of the following signs or symptoms:
  • severe muscle pain
  • unexplained muscle weakness
  • unexplained soreness
  • dark, reddish urine.
• Bone fractures. Taking elafibranor may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, if you develop pain, or have changes in your ability to move around.
• Liver problems. 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. Tell your healthcare provider right away if you have any of the following signs or symptoms of worsening liver problems during treatment:
  • swelling of your stomach area (abdomen) from a build-up of fluid
  • yellowing of your skin or the whites of your eyes
  • black, tarry, or bloody stools
  • coughing up or vomiting blood, or your vomit looks like “coffee grounds”
  • mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality.

Tell your healthcare provider right away if you have any of the following symptoms during treatment with elafibranor and they are severe or do not go away:

• • stomach-area (abdomen) pain
  • nausea, vomiting, diarrhea
  • loss of appetite or weight loss
  • new or worsening fatigue 
  • weakness
  • fever and chills
  • light-headedness
  • less frequent urination.
• Allergic reactions have occurred in some people taking elafibranor. The reactions happened 2 to 30 days after taking it and included symptoms such as rash, itching, trouble breathing, and swelling of your face, lips, tongue, or throat. If you have any of these symptoms, stop taking elafibranor and call your healthcare provider right away or go to the nearest hospital emergency room.
• Blockage of the bile duct. Taking elafibranor may increase your risk of gallstone development. Call your healthcare provider right away if you develop any signs or symptoms of gallstones, including pain in the upper right stomach area or yellowing of the skin

May cause harm to an unborn baby. If you are a female with the ability to become pregnant, your healthcare provider may conduct a pregnancy test before prescribing elafibranor.

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

It is not known if elafibranor is safe and effective in children under 18 years of age.

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

Do not take elafibranor if you have signs or symptoms of advanced liver disease (decompensated cirrhosis).

• Symptoms may include confusion; fluid in the stomach area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood, or having vomit that looks like “coffee grounds”.

Before taking elafibranor, tell your healthcare provider about all of your medical conditions, including if you:

• have advanced liver disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Your healthcare provider should check for muscle pain or weakness before you start taking elafibranor. Tell your healthcare provider right away if you have new and/or severe muscle pain or muscle weakness. 

Pregnancy

Elafibranor can harm your unborn baby. You should not become pregnant during treatment with elafibranor.

Pregnancy Safety Study. If you become pregnant while taking elafibranor, tell your healthcare provider right
away. There is a pregnancy safety study for women who become pregnant while taking this medicine. Talk to your
healthcare provider about providing information to the pregnancy safety study. The purpose of this
study is to collect information about your health and your baby’s health. You or your healthcare provider can
report your pregnancy by calling 1-855-463-5217 or visiting https://www.ipsen.com/contact-us/

Females who can become pregnant:

• You should use effective birth control during treatment and for 3 weeks after the last dose of IQIRVO. Talk to your healthcare provider about birth control methods that may be right for you
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

Breastfeeding

It is not known if elafibranor passes into your breast milk. Do not breastfeed while taking elafibranor and for 3 weeks after the last dose. Talk with your healthcare provider about the best way to feed your baby if you take elafibranor.

How is elafibranor administered?

Take elafibranor exactly as your healthcare provider tells you to.

• Elafibranor is a tablet that is taken once a day. 
• May be taken with or without food.

If you take a bile acid binding resin (such as cholestyramine or colestipol), take elafibranor at least 4 hours before or 4 hours after you take your bile acid binding resin.

• If this is not possible, space the time between taking elafibranor and your bile acid-binding resin as far apart as possible.

Your healthcare provider will monitor your liver function while you are being treated with elafibranor and may adjust or discontinue treatment if you have evidence of liver toxicity or decompensated cirrhosis.

Dosing information

Adult dose for PBC: elafibranor 80 mg 1 time a day.

What happens if I miss a dose?

If you miss a dose of elafibranor, take the dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your usual dosing schedule. Do not double up on doses.

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 contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after the last dose of elafibranor
• HMG-CoA reductase inhibitors (also called statins, such as atorvastatin, pravastatin, or lipostatin). Your healthcare provider will need to monitor you for signs and symptoms of muscle injury
• Rifampin. Your healthcare provider will need to monitor liver enzymes such as alkaline phosphatase and bilirubin if you start taking rifampin during elafibranor treatment
• 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) 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.

Genfit was the original developer of elafibranor, but Ipsen acquired the exclusive worldwide license rights to develop and commercialize elafibranor from Genfit in July 2023.

Further information

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

Medical Disclaimer