Pronunciation: el-a-fib-ran-nor
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 Mar 23, 2025.

What is elafibranor?

Elafibranor is used to treat primary biliary cholangitis (PBC) in adults either alone or in combination with ursodiol. It is a tablet that is taken once daily.

Elafibranor gained FDA approval on 10 June 2024 under the brand name Iqirvo. There is no generic.

• This approval is 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, 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. By activating these receptors, elafibranor reduces inflammation, improves bile acid metabolism, and reduces bile acid toxicity in liver cells in patients with PBC. 

Elafibranor side effects

The most common side effects of elafibranor are:

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

Serious side effects and warnings

Elafibranor can cause the following serious side effects.

Elafibranor can cause muscle pain or worsen existing pain. This could be a sign of muscle damage. Your doctor should check for muscle problems before and during treatment. If you develop new or worsening muscle pain, contact your doctor right away. They may do a blood test to check your creatine phosphokinase (CPK) levels. 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, or dark, reddish urine.

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.

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
• mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech,
• yellowing of your skin or the whites of your eyes
• mood swings, or changes in personality
• black, tarry, or bloody stools
• coughing up or vomiting blood, or your vomit looks like “coffee grounds”.

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.

Taking elafibranor may increase your risk of gallstone development and bile duct blockage. 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

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
• weakness
• nausea, vomiting, diarrhea
• fever and chills
• loss of appetite or weight loss
• light-headedness
• new or worsening fatigue
• less frequent urination.

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 the level of an enzyme in your blood related to muscle activity called creatine phosphokinase (CPK).

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

You should 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 liver disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• new and/or severe muscle pain or muscle weakness.

Pregnancy

Elafibranor can harm your unborn baby. You should not become pregnant during treatment. Females who can become pregnant should use effective birth control during treatment and for 3 weeks after the last dose of elafibranor. Talk to your healthcare provider about birth control methods that may be right for you.

If you become pregnant while receiving elafibranor, tell your healthcare provider right away. There is a pregnancy safety study for women who become pregnant while taking elafibranor, the purpose of which 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/.

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 should I take elafibranor?

Take elafibranor exactly as your healthcare provider tells you to.

• The usual dosage is 1 tablet once daily.
• 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: elafibrinaor 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 of 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.

Elafibranor ingredients

Elafibranor is only available as the brand Iqirvo.

Iqirvo active ingredient: elafibranor

Iqirvo 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.

Who makes elafibranor?

Elafibranor is manufactured under the brand name Iqirvo by Ipsen Biopharmaceuticals, Inc. 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