Is Iqirvo (elafibranor) FDA approved?

The FDA gave Iqirvo (elafibranor) an accelerated approval in [June 2024](https://www.ipsen.com/press-releases/ipsens-iqirvo-receives-u-s-fda-accelerated-approval-as-a-first-in-class-ppar-treatment-for-primary-biliary-cholangitis/) for treating [primary biliary cholangitis (PBC)](https://liverfoundation.org/liver-diseases/autoimmune-liver-diseases/primary-biliary-cholangitis-pbc/) in adults. You can take Iqirvo together with [ursodiol (Actigall)](https://www.goodrx.com/ursodiol/what-is), or also known as ursodeoxycholic acid. You can also take Iqirvo (elafibranor) by itself if you can’t take ursodiol (Actigall). This [accelerated approval](https://www.goodrx.com/drugs/medication-basics/fda-accelerated-approval) is a way for the [FDA](https://www.goodrx.com/drugs/medication-basics/what-does-the-fda-do) to bring Iqirvo (elafibranor) into the market quickly. This is important because people with PBC need more treatment options. Unmanaged PBC can lead to liver failure, which could possibly need a liver transplant. More research is needed to know for sure whether Iqirvo helps people with PBC live longer or prevent more liver damage.

How well does Iqirvo (elafibranor) work for primary biliary cholangitis (PBC)?

A year-long [study](https://www.nejm.org/doi/full/10.1056/NEJMoa2306185) showed that Iqirvo (elafibranor) helped lower [alkaline phosphatase (ALP)](https://medlineplus.gov/ency/article/003470.htm) levels in most adults with PBC. ALP is a type of [liver enzyme](https://www.goodrx.com/health-topic/liver/elevated-liver-enzymes), and high ALP levels are [typical](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01303-5/fulltext) for people with PBC. It's not clear or proven yet whether lower ALP levels actually helps people with PBC live longer or prevents more liver problems. Ask your prescriber if you have questions about how well the medication works and if it's right for you.

How long does it take Iqirvo (elafibranor) to work?

In a clinical study, Iqirvo (elafibranor) helped lower [alkaline phosphatase (ALP)](https://medlineplus.gov/ency/article/003470.htm) levels (a type of liver enzyme) [within the first 4 weeks](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d78aa14f-6ec1-4b1d-a4ae-e48658137a25&type=display#section-12:~:text=Figure%201%3A%20Mean%20ALP%20(%2B/%2D%2095%25%20Confidence%20Interval)%20in%20Adult%20Patients%20with%20PBC%20Over%2052%20Weeks%20in%20Study%201). ALP levels stayed lower for the rest of the year during the study. Keep in mind that it’s not clear what having lower ALP levels means for people with PBC yet. We don’t know yet if this helps people with PBC live longer or prevents more liver problems. Your prescriber will ask you to get blood tests done while you’re taking Iqirvo (elafibranor) to check your ALP levels. Talk to your prescriber about your test results.

Does Iqirvo (elafibranor) cause weight gain?

In a study, [around 20%](https://www.nejm.org/doi/10.1056/NEJMoa2306185?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed#sec-2:~:text=SAFETY%20AND%20ADVERSE%20EVENTS) of people who took Iqirvo (elafibranor) had weight gain. But almost the same percentage of people who took [placebo](https://www.goodrx.com/well-being/alternative-treatments/placebo-effect) also gained weight. So it's not clear if Iqirvo (elafibranor) is the cause. Keep in mind that people with [severe, advanced PBC](https://rarediseases.org/rare-diseases/primary-biliary-cholangitis/) sometimes lose weight. So weight gain could be a sign that the liver condition is improving. Also note that a small number of people who took Iqirvo (elafibranor) reported weight loss in the study. Contact your prescriber if you notice unexplained changes in your weight while you're taking Iqirvo (elafibranor).

What are the similarities and differences between Iqirvo and Livdelzi?

[Iqirvo (elafibranor)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d78aa14f-6ec1-4b1d-a4ae-e48658137a25) and [Livdelzi (seladelpar)](https://www.goodrx.com/livdelzi/what-is) work in similar ways to help adults with PBC. They’re both taken once daily and are options for those who’ve already tried [ursodiol (Actigall)](https://www.goodrx.com/ursodiol/what-is). The two medications haven’t been directly compared to each other. But in the separate [Iqirvo study](https://www.nejm.org/doi/full/10.1056/NEJMoa2306185) and [Livdelzi study](https://www.nejm.org/doi/full/10.1056/NEJMoa2312100), both lowered alkaline phosphatase ([ALP](https://medlineplus.gov/ency/article/003470.htm)) levels over a year. This could mean that the medications might help slow PBC, but more research is needed. In the Livdelzi study, the medication helped relieve itching, a common [symptom of liver problems](https://www.goodrx.com/conditions/liver-disease). But it wasn’t clear whether Iqirvo had a similar benefit in its own study. Also, muscle pain was a possible side effect of Iqirvo but wasn’t reported in the Livdelzi study. Talk to your prescriber to [compare between](https://www.goodrx.com/compare/iqirvo-vs-livdelzi) Iqirvo and Livdelzi.

Iqirvo

elafibranor

Used for Liver Disease

Iqirvo (elafibranor) has an accelerated approval from the FDA for treating primary biliary cholangitis (PBC) in adults. It works as a peroxisome proliferator-activated receptor (PPAR) agonist to help the body make less bile acid. But it’s not clear yet if the medication helps people with PBC live longer or helps the liver improve. Iqirvo (elafibranor) comes as an 80 mg tablet that's taken by mouth once per day. You can take Iqirvo (elafibranor) by itself or with ursodiol (Actigall). Side effects of Iqirvo (elafibranor) include weight gain, diarrhea, and stomach pain.

Reviewed by:

Robert Chad Hakim, PharmD, BCCCP

Gianna Christodoulopoulos, PharmD Candidate

Cydnee Ng, PharmD

Last reviewed on March 3, 2025

What is Iqirvo (elafibranor)?

What is Iqirvo (elafibranor) used for?

Primary biliary cholangitis (PBC), a liver problem caused by damaged bile ducts

How Iqirvo (elafibranor) works

Iqirvo (elafibranor) is a peroxisome proliferator-activated receptor (PPAR) agonist. It attaches to certain PPAR receptors in the liver.

It's not completely clear how Iqirvo (elafibranor) works to help with primary biliary cholangitis (PBC). But it's thought to stop the liver from making bile acids, a component of bile. This is important because people with PBC have too much bile in the liver, which can hurt the liver.

Drug facts

Common BrandsIqirvo

Drug ClassPeroxisome proliferator-activated receptor (PPAR) agonist

Controlled Substance ClassificationNot a controlled medication

Generic StatusNo lower-cost generic available

AvailabilityPrescription only

Side effects of Iqirvo (elafibranor)

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Weight gain (23%)
Diarrhea (11%)
Stomach pain (11%)
Nausea (11%)
Vomiting (11%)
Joint pain (8%)
Constipation (8%)
Muscle pain (7%)
Broken bone (fracture, 6%)
Heartburn (6%)
Dry mouth (5%)
Weight loss (5%)
Rash (5%)

Less Common Side Effects

Dizziness
Stomach flu
Gallstones
Higher creatinine levels
Low red blood cell count (anemia)

Iqirvo (elafibranor) serious side effects

Contact your healthcare provider immediately if you experience any of the following.

Severe muscle damage (rhabdomyolysis): dark brown urine, severe muscle weakness or pain, fever, tiredness
Worsening liver problems: swelling of your stomach; yellowing of your skin or the whites of your eyes; stool changes (black, tarry, or bloody stools); coughing or vomiting up blood; confusion; slurred speech; changes in personality
Bone fracture: bone looks misshapen, swelling, bruising, pain
Allergic reactions: rash; itching; trouble breathing; swelling of your face, lips, tongue, or throat

Source: DailyMed

The following Iqirvo (elafibranor) side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

Diarrhea
Joint pain
Nausea
Stomach pain
Vomiting
Weight gain

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Pros and cons of Iqirvo (elafibranor)

Pros

Taken by mouth once per day
A good option if treatment with ursodiol (Actigall) isn't enough or if you can't take ursodiol (Actigall)
Helps improve levels of alkaline phosphatase (ALP), a liver enzyme that can be high with liver damage

Cons

Might cause muscle pain
Can raise the risk of bone fractures
Not known for sure if the medication helps people with PBC live longer or slow down liver damage

Pharmacist tips for Iqirvo (elafibranor)

Mark your calendar with your appointments to see your prescriber. Also make sure to get blood work done to check your liver function. These follow-ups are important to see how well Iqirvo (elafibranor) is well and check for side effects.
Take Iqirvo (elafibranor) with or without food at any time of day. But taking it with food might help with any stomach pain, nausea, vomiting, and acid reflux from the medication. These are common side effects of Iqirvo (elafibranor).
Iqirvo (elafibranor) can raise the risk of fractures (broken bone). Get medical care if you think you've broken a bone and have swelling, bruising, and pain when you move the bone. Tell your prescriber if you have any bone problems, like osteoporosis.
Tell your prescriber and pharmacist about all the medications you take. Don't start any new ones without talking to your care team first. Iqirvo (elafibranor) can interact with other medications, so your care team should make sure they're all safe to take together. Some examples of medications that interact with Iqirvo (elafibranor) include statins, rifampin (Rifadin), and hormonal birth control.
If you take bile acid sequestrants like colesevelam (Welchol), colestipol (Colestid), or cholestyramine (Prevalite), take them at least 4 hours before or 4 hours after Iqirvo (elafibranor). If that's not possible, try to take the bile acid sequestrant and Iqirvo (elafibranor) as far apart as you can. Taking them too close together can make Iqirvo (elafibranor) work less well.
If you're sexually active and can get pregnant, use nonhormonal birth control, like Paragard (copper intrauterine device) or condoms, while taking Iqirvo (elafibranor). If you use hormonal birth control, use a barrier method, like condoms, too. Iqirvo (elafibranor) can make hormonal birth control work less well and raise the risk of pregnancy. Keep using birth control for at least 3 weeks after your last dose of Iqirvo (elafibranor). This is important because the medication can harm an unborn baby.
Let your care team know right away if you become pregnant while you're taking Iqirvo (elafibranor). You'll probably need to stop taking the medication because it can cause harm to an unborn baby.

Common questions about Iqirvo

The FDA gave Iqirvo an accelerated approval in June 2024 for treating primary biliary cholangitis (PBC) in adults. You can take Iqirvo together with ursodiol (Actigall), or also known as ursodeoxycholic acid. You can also take Iqirvo by itself if you can’t take ursodiol (Actigall). This accelerated approval is a way for the FDA to bring Iqirvo into the market quickly. This is important because people with PBC need more treatment options. Unmanaged PBC can lead to liver failure, which could possibly need a liver transplant. More research is needed to know for sure whether Iqirvo helps people with PBC live longer or prevent more liver damage.

A year-long study showed that Iqirvo helped lower alkaline phosphatase (ALP) levels in most adults with PBC. ALP is a type of liver enzyme, and high ALP levels are typical for people with PBC. It's not clear or proven yet whether lower ALP levels actually helps people with PBC live longer or prevents more liver problems. Ask your prescriber if you have questions about how well the medication works and if it's right for you.

In a clinical study, Iqirvo helped lower alkaline phosphatase (ALP) levels (a type of liver enzyme) within the first 4 weeks. ALP levels stayed lower for the rest of the year during the study. Keep in mind that it’s not clear what having lower ALP levels means for people with PBC yet. We don’t know yet if this helps people with PBC live longer or prevents more liver problems. Your prescriber will ask you to get blood tests done while you’re taking Iqirvo to check your ALP levels. Talk to your prescriber about your test results.

In a study, around 20% of people who took Iqirvo had weight gain. But almost the same percentage of people who took placebo also gained weight. So it's not clear if Iqirvo is the cause. Keep in mind that people with severe, advanced PBC sometimes lose weight. So weight gain could be a sign that the liver condition is improving. Also note that a small number of people who took Iqirvo reported weight loss in the study. Contact your prescriber if you notice unexplained changes in your weight while you're taking Iqirvo.

Hair loss wasn't a reported side effect of Iqirvo in clinical studies. Contact your healthcare team if you notice hair loss, shedding, or thinning while you're taking Iqirvo. Your care team can help figure out what might be causing it.

Don’t breastfeed while you’re taking Iqirvo and for at least 3 weeks after your last dose. There isn’t enough information about whether the medication passes into breast milk or whether it can harm your baby. If you’re breastfeeding or plan to nurse, talk to your prescriber or lactation consultant about safe feeding options.

Some people shouldn’t take Iqirvo for safety reasons. Avoid taking Iqirvo if you have moderate or severe liver problems, like severe cirrhosis. Also avoid it if you have a bile duct blockage (biliary obstruction). This medication might make your condition worse. People who are pregnant or breastfeeding also shouldn’t take Iqirvo. The medication might harm your baby. And talk to your prescriber if you’ve had muscle pain, bone fractures, or osteoporosis before. You might be more likely to have these side effects. Before starting Iqirvo, check with your prescriber to make sure it’s safe for you. There might be other options that are safer for you.

Iqirvo and Livdelzi (seladelpar) work in similar ways to help adults with PBC. They’re both taken once daily and are options for those who’ve already tried ursodiol (Actigall). The two medications haven’t been directly compared to each other. But in the separate Iqirvo study and Livdelzi study, both lowered alkaline phosphatase (ALP) levels over a year. This could mean that the medications might help slow PBC, but more research is needed. In the Livdelzi study, the medication helped relieve itching, a common symptom of liver problems. But it wasn’t clear whether Iqirvo had a similar benefit in its own study. Also, muscle pain was a possible side effect of Iqirvo but wasn’t reported in the Livdelzi study. Talk to your prescriber to compare between Iqirvo and Livdelzi.

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Risks and warnings for Iqirvo (elafibranor)

Iqirvo (elafibranor) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Muscle pain, weakness, and damage

Risk factors: Taking other medications that can also cause muscle problems (e.g., statins)

Some people who took Iqirvo (elafibranor) had muscle pain and weakness. This can happen months after starting the medication. In a rare case, one person had a severe muscle problem called rhabdomyolysis, which led to kidney damage. The risk for muscle pain and damage might be higher if you take other medications that can also cause muscle damage (e.g., statins).

Let your care team know right away if you feel any new or worsening muscle pain, weakness, or tenderness while taking Iqirvo (elafibranor). And get medical attention if you have severe muscle pain or dark-colored urine. These can be signs of rhabdomyolysis.

Liver problems

Risk factors: History of liver problems | Drinking large amounts of alcohol

Iqirvo (elafibranor) can sometimes cause injury to the liver. Some people who took this medication had elevated liver enzymes. This can mean that there’s stress or damage to the liver. Iqirvo (elafibranor) isn’t recommended for people with moderate or severe liver problems or advanced stages of cirrhosis.

You'll need blood tests before you start treatment so your prescriber can check your liver health. You’ll probably also need regular blood tests to check your liver as you take Iqirvo (elafibranor).

Get medical help right away if you have a swollen stomach, pain on the right side of your stomach, yellow skin or eyes, confusion, or changes in personality or mood. These can be signs of worsening liver damage. Your prescriber might tell you to stop taking Iqirvo (elafibranor) to prevent more liver damage.

Fractures

Risk factors: History of fractures | Osteoporosis

In clinical studies, 6% of people taking Iqirvo (elafibranor) had a fracture (broken bone). Some fractures happened a few months after starting the medication. Tell your prescriber if you’ve broken a bone before or if you have osteoporosis. They might want to check your bone health during treatment with blood tests for calcium levels or bone density screenings (DEXA scan).

Get medical care right away if you think you’ve broken a bone. Signs include bruising, swelling, a bone looking “out of place,” or pain when you try to move a limb.

Risk of harm to a baby during pregnancy

Talk to your healthcare team if you're pregnant or thinking of becoming pregnant. You should avoid getting pregnant while you’re taking Iqirvo (elafibranor) and for at least 3 weeks after your last dose of the medication.

There aren’t any pregnancy studies done in people. But animal studies found that Iqirvo (elafibranor) might cause harm to an unborn baby if it’s taken during pregnancy. In the animal studies, there were harmful consequences, like loss of the baby and low body weight.

Before starting Iqirvo (elafibranor), take a pregnancy test as instructed to make sure you’re not pregnant. If you can become pregnant and are sexually active, use nonhormonal birth control, like Paragard (copper intrauterine device) or condoms, during treatment. If you prefer hormonal birth control, also use a barrier method like condoms. Iqirvo (elafibranor) can make hormonal birth control work less well and raise the risk of pregnancy. Keep using birth control for at least 3 weeks after your last dose of Iqirvo (elafibranor).

Avoid in people with biliary obstruction

Risk factors: History of bile duct problems | Complete biliary obstruction

People with a complete bile duct blockage (biliary obstruction) should avoid taking Iqirvo (elafibranor). Call a healthcare professional right away if you have pain in the upper right side of your stomach belly or yellowing of your skin and eyes. These could be signs of a blockage. Your prescriber might ask you to stop taking Iqirvo (elafibranor) while they check and treat you for this blockage.

Iqirvo (elafibranor) dosage

The average cost for 30 tablets of 80mg of Iqirvo (elafibranor) is $11,908.56 with a free GoodRx coupon. This is 21.18% off the average retail price of $15,109.46.

Tablet

Dosage	Quantity	Price as low as	Price per unit
80mg	30 tablets	$11,908.56	$396.95

Typical dosage for Iqirvo (elafibranor)

The typical dose is 80 mg (1 tablet) by mouth once per day.

How much does Iqirvo (elafibranor) cost?

To access savings, use a GoodRx coupon and pay just a fraction of the retail price.

Iqirvo (brand)

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$11,908.56

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What are alternatives to Iqirvo (elafibranor)?

There are a number of medications that your doctor can prescribe in place of Iqirvo (elafibranor). Compare a few possible alternatives below.

Iqirvo (elafibranor)

Used for:

Primary biliary cholangitis (PBC), a liver problem caused by damaged bile ducts

$11,908.56Lowest GoodRx priceView prices

Ocaliva (obeticholic acid)

Used for:

Primary biliary cholangitis

View prices

Livdelzi (seladelpar)

Used for:

Primary biliary cholangitis (PBC), a liver condition due to damaged bile ducts

$12,416.30Lowest GoodRx priceView prices

References

Best studies we found

American Liver Foundation. (2024). Primary biliary cholangitis (PBC).

Hirschfield, G. M., et al. (2024). A phase 3 trial of seladelpar in primary biliary cholangitis. The New England Journal of Medicine.

Ipsen Biopharmaceuticals, Inc. (2024). Iqirvo- elafibranor tablet, film coated [package insert]. DailyMed.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

Iqirvo