Elafibranor
Elafibranor is a PPAR agonist used to treat primary biliary cholangitis (PBC), a chronic liver disease, in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Elafibranor (Iqirvo), on the U.S. market since 2024, is a specialist medicine for primary biliary cholangitis (PBC), an autoimmune liver disease. It is added to UDCA (ursodiol) when that falls short, or used alone when UDCA is not tolerated, and it switches on PPAR proteins to slow bile acid production. Most people tolerate it fairly well, and stomach upset (diarrhea, nausea, belly pain) and weight gain are what people notice most. Watch for muscle injury, reporting new muscle pain, weakness or dark urine right away, especially if you also take a statin. Its approval rests on lowering ALP, a liver enzyme, and proof that it prevents liver failure or improves survival is still pending.
Clinical pearls
- It may harm an unborn baby and weaken ethinyl estradiol birth control, so switch methods until three weeks after stopping.
- Take it at least four hours before or after cholestyramine or another bile acid binder, which blocks its absorption.
- Gemfibrozil should be avoided, and fenofibrate or pioglitazone add liver or muscle risk, so tell every prescriber you take it.
- Report any new fracture and any yellowing of skin or eyes, since bone fractures and liver injury are both listed risks.
Patient information guide A plain-language walkthrough of Elafibranor, written from its FDA label.
What Elafibranor is used for
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Elafibranor is used to treat primary biliary cholangitis (PBC), a chronic liver disease, in adults.
- Iqirvo is approved for PBC in combination with ursodeoxycholic acid (UDCA) in adults whose disease has not responded adequately to UDCA alone
- Iqirvo is also approved as monotherapy for adults with PBC who cannot tolerate UDCA
- Approval is based on reduction of alkaline phosphatase (ALP), a liver enzyme elevated in PBC — not yet on demonstrated improvement in survival or prevention of liver decompensation
- Iqirvo is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, or hepatic encephalopathy)
How Elafibranor works
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Elafibranor and its main active metabolite (GFT1007) activate proteins called peroxisome proliferator-activated receptors — PPAR-alpha, PPAR-gamma, and PPAR-delta. One important effect is reducing bile acid synthesis, which helps limit the buildup of bile acids that can damage liver cells and bile ducts in people with PBC. The PPAR-alpha and PPAR-delta pathways appear most relevant to this effect. The exact mechanism by which elafibranor benefits people with PBC is not yet fully understood.
Elafibranor dosage
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Iqirvo is taken as an oral tablet once daily, with or without food. Eating a high-fat meal may slightly delay absorption, but this is not clinically meaningful and does not require taking it on an empty stomach. If you also take a bile acid sequestrant, space Iqirvo at least 4 hours apart from it to prevent it from interfering with absorption.
- Take it at the same time each day as directed by your prescriber
- Do not adjust your dose without talking to your doctor
Dosing details from the FDA-approved label
From the Elafibranor prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (all patients; the label names no specific indication in this section)
- 80 mg taken orally once daily with or without food
- Before treatment, evaluate for muscle pain or myopathy and verify that females of reproductive potential are not pregnant. Administer at least 4 hours before or 4 hours after a bile acid sequestrant, or at as great an interval as possible.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Before treatment, evaluate for muscle pain or myopathy, and/or verify that females of reproductive potential are not pregnant. ( 2.1 ) The recommended dosage is 80 mg orally once daily with or without food. ( 2.2 ) 2.1 Recommended Evaluation Before Initiating IQIRVO Before initiating IQIRVO: Evaluate for muscle pain or myopathy [see Warnings and Precautions (5.1) ] . Verify that females of reproductive potential are not pregnant prior to initiating treatment with IQIRVO [ see Warnings and Precautions (5.3) , Use in Specific Populations (8.1 , 8.3) ] . 2.2 Recommended Dosage and Administration The recommended dosage of IQIRVO is 80 mg taken orally once daily with or without food [see Clinical Pharmacology (12.3) ] . 2.3 Administration Modification for Bile Acid Sequestrants Administer IQIRVO at least 4 hours before or 4 hours after administering the bile acid sequestrant, or at as great an interval as possible [see Drug Interactions (7.2) ] .
Read the full Dosage and Administration section on DailyMed →
Elafibranor side effects
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The most commonly reported side effects with Iqirvo (occurring in 5% or more of patients) include:
Common side effects
- Weight gain
- Diarrhea, nausea, vomiting, or abdominal pain
- Constipation
- Joint pain (arthralgia)
- Muscle pain
- Gastroesophageal reflux disease (acid reflux)
- Dry mouth
- Rash
- Weight loss
When to get medical help
- Call your doctor if you develop new or worsening muscle pain, weakness, or dark-colored urine — these can be signs of serious muscle injury (myopathy or rhabdomyolysis)
- Tell your doctor right away if you notice yellowing of the skin or eyes, right-sided abdominal pain, or other signs of liver problems
- Seek medical attention immediately for signs of a severe allergic reaction — severe rash, swelling, or difficulty breathing
- Report any new bone fractures to your doctor, as Iqirvo has been associated with an increased risk of fractures
- If you experience symptoms of biliary obstruction (severe abdominal pain, jaundice), contact your doctor right away
Serious reactions that require prompt medical attention include muscle breakdown (rhabdomyolysis), drug-induced liver injury, bone fractures, severe allergic reactions, and biliary obstruction. Contact your doctor right away if you experience muscle pain with dark urine, yellowing of the skin, severe abdominal pain, or signs of an allergic reaction.
Elafibranor warnings and precautions
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- Muscle injury (myalgia, myopathy, rhabdomyolysis): Serious muscle breakdown has occurred, including one case leading to acute kidney injury. Risk is higher when combined with statins or other PPAR-alpha agonists. Your doctor should assess muscle health before starting and periodically during treatment.
- Drug-induced liver injury: Cases of liver injury, including one resembling autoimmune hepatitis, have been reported. Liver tests should be monitored throughout treatment. Stop Iqirvo if liver tests worsen or symptoms of hepatitis appear.
- Fetal harm: Animal studies showed serious effects on offspring at drug exposures similar to human doses. Women who can become pregnant must confirm a negative pregnancy test before starting and must use effective contraception (not ethinyl-estradiol-based pills) during treatment and for 3 weeks after the last dose.
- Fractures: Bone fractures occurred in 6% of Iqirvo-treated patients vs. none with placebo. Bone health should be monitored according to standard care.
- Hypersensitivity reactions: Allergic reactions including rash have occurred. Severe reactions require permanent discontinuation.
- Biliary obstruction: Iqirvo should be avoided in complete biliary obstruction and interrupted if obstruction is suspected.
Elafibranor interactions
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Iqirvo has several important drug interactions to be aware of:
- Ethinyl estradiol-containing contraceptives: Iqirvo weakly induces an enzyme (CYP3A4) that breaks down ethinyl estradiol, reducing contraceptive effectiveness — switch to levonorgestrel/norgestrel-only, intrauterine systems, or non-hormonal contraception
- Statins (HMG-CoA reductase inhibitors): Combining with Iqirvo increases the risk of muscle injury; monitor closely
- Gemfibrozil and other strong CYP2C8 inhibitors: Can raise levels of Iqirvo's active metabolite — avoid if possible
- Other PPAR-alpha agonists (e.g., fenofibrate, fenofibric acid): Increased risk of both liver injury and muscle injury
- PPAR-gamma agonists (e.g., pioglitazone, rosiglitazone): Increased risk of liver injury
- Rifampin: Speeds up metabolism of Iqirvo, potentially reducing its effectiveness — monitor ALP and bilirubin
- Bile acid sequestrants (e.g., cholestyramine): Can reduce Iqirvo absorption — take at least 4 hours apart
Interactions listed in the FDA-approved label
From the Elafibranor prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Hormonal Contraceptives: IQIRVO is a weak CYP3A4 inducer; co-administration with a combined oral hormonal contraceptive decreased ethinylestradiol, which may lead to contraceptive failure and/or an increase in breakthrough bleeding, while levonorgestrel exposure remained unaffected. Switch to progestin only product containing levonorgestrel/norgestrel, intrauterine system, or effective non-hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose.
- HMG-CoA Reductase Inhibitors (statins): CPK elevation and/or myalgia occurred on IQIRVO monotherapy; co-administration with statins which have a risk of myalgia can increase the risk of myopathy by a mechanism that has not been fully characterized. Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy.
- Strong CYP2C8 Inhibitors (e.g. gemfibrozil): The major active metabolite GFT1007 is a CYP2C8 substrate; a strong CYP2C8 inhibitor may increase systemic exposure of GFT1007, which may increase the risk of IQIRVO adverse reactions. Avoid concomitant use. If concomitant use cannot be avoided, monitor patients for adverse reactions.
- Other PPAR-alpha agonists (e.g., fenofibrate, fenofibric acid): Co-administration may increase risk of liver injury and muscle injury. Monitor for signs and symptoms of liver injury and muscle injury.
- Other PPAR-gamma agonists (e.g., pioglitazone, rosiglitazone): Co-administration may increase risk of liver injury. Monitor for signs and symptoms of liver injury.
- Rifampin: Rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor and its active metabolite via increased metabolism and may result in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO.
- Bile Acid Binding Sequestrants: Bile acid sequestrants may interfere with the action of IQIRVO by reducing its absorption and systemic exposure, which may reduce IQIRVO efficacy. Administer IQIRVO at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible.
Read the label’s full interactions text
7 DRUG INTERACTIONS Hormonal Contraceptives: Switch to progestin only products containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment and for at least 3 weeks after last dose. ( 5.3 , 7.1 ) HMG-CoA Reductase Inhibitors : Monitor for signs and symptoms of muscle injury. ( 5.1 , 7.1 ) Strong CYP2C8 Inhibitors: Avoid concomitant use with strong CYP2C8 inhibitors (e.g. gemfibrozil). If concomitant use cannot be avoided, monitor patients for adverse reactions. ( 7.2 ) Other Peroxisome Proliferator-Activated Receptor-Alpha (PPAR-alpha) Agonists : Monitor for signs and symptoms of liver injury and muscle injury. (7.2) Other PPAR-gamma Agonists : Monitor for signs and symptoms of liver injury (7.2) Rifampin: Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during IQIRVO treatment. ( 7.2 ) Bile Acid Sequestrants: Administer at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible. ( 2.3 , 7.2 ) 7.1 Effects of IQIRVO on Other Drugs Table 3 includes clinically significant drug interactions affecting other drugs. Table 3: Clinically Significant Interactions Affecting Other Drugs Hormonal Contraceptives Clinical Impact IQIRVO is a weak CYP3A4 inducer [see Clinical Pharmacology (12.3) ] . A clinical interaction study demonstrated that co-administration of IQIRVO and a combined oral hormonal contraceptive produced a decrease of ethinylestradiol which may lead to contraceptive failure and/or an increase in breakthrough bleeding, while levonorgestrel exposure remained unaffected. Intervention Switch to progestin only product containing levonorgestrel/norgestrel, intrauterine system, or effective non-hormonal contraceptives when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1 , 8.3) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Elafibranor
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- Tell your doctor if you have any current muscle pain or a history of muscle disease before starting Iqirvo
- Women who could become pregnant must have a negative pregnancy test before starting — Iqirvo may harm an unborn baby
- Do not use Iqirvo if you are pregnant; if you become pregnant while taking it, contact your doctor immediately
- Do not breastfeed during treatment or for 3 weeks after the last dose
- Iqirvo is not recommended in patients with decompensated cirrhosis (advanced liver scarring with complications)
- Patients with cirrhosis should be monitored closely for signs of liver worsening
- Patients older than 75 years may have higher drug levels in their blood and should be monitored more closely for side effects
- Iqirvo has not been studied in children — it is not approved for pediatric use
- No dose adjustment is needed for kidney disease or mild liver impairment, but tell your doctor about any kidney or liver condition
What Elafibranor does in the body
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In clinical studies, Iqirvo at 80 mg once daily reduced levels of alkaline phosphatase (ALP) — a key liver enzyme elevated in PBC — as early as 4 weeks after starting treatment. This reduction was sustained through 52 weeks. Iqirvo did not cause any significant effect on the heart's electrical rhythm (QTc interval) even at doses nearly four times the recommended amount.
How your body processes Elafibranor
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After daily dosing, elafibranor reaches steady-state levels in the blood within about two weeks, and its active metabolite GFT1007 within about one week. The drug can be taken with or without food — a high-fat meal slightly reduces peak concentration but does not meaningfully affect total drug exposure. Elafibranor is broken down mainly in the liver into its active metabolite (GFT1007), which circulates at levels about three times higher than the parent drug. Elafibranor has a long half-life of around 70 hours, while GFT1007's half-life is about 15 hours. Most of the drug is eliminated in feces, with a smaller amount leaving through urine.
How to store Elafibranor
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Store at room temperature 15°C to 30°C (59°F to 86° F). Store in the original package (bottle and carton) to protect from moisture and light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Elafibranor: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Elafibranor — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is primary biliary cholangitis, and why do I need this medication?
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How should I take Iqirvo, and does it matter if I take it with food?
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What side effects should I expect, and which ones should make me call my doctor?
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I'm on a statin for cholesterol. Is it safe to take Iqirvo at the same time?
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I'm a woman of childbearing age. Is there anything special I need to know?
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My doctor said this approval is 'accelerated' — what does that mean for me?
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Is Elafibranor available over the counter?
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When was Elafibranor first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Elafibranor on HelloPharmacist
Elafibranor forms and strengths (how it comes)
Elafibranor is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Iqirvo is used to treat primary biliary cholangitis (PBC) in adults who have not responded adequately to UDCA, taken together with UDCA
- Iqirvo is used as monotherapy in adults with PBC who cannot tolerate UDCA
- Iqirvo is taken by mouth once daily, with or without food
- If you also take a bile acid sequestrant, take Iqirvo at least 4 hours before or 4 hours after that medication
- Iqirvo should not be used in patients who have decompensated cirrhosis
- Before starting Iqirvo, a pregnancy test is required for women who could become pregnant
Elafibranor on the U.S. market: products, makers and brands
How Elafibranor appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Elafibranor product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2024. Brand names on the directory include Iqirvo; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Elafibranor is used (Medicaid data)
A general measure of how commonly Elafibranor is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Elafibranor is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Elafibranor prescribed? Of the 1,601 medications we measure, Elafibranor ranks #1,388 by Medicaid prescriptions — more than 13% of them.
Utilization by Elafibranor product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
elafibranor 80 MG Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2684946
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Elafibranor, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Elafibranor NDCs with Medicaid activity.
Compare Elafibranor products
A representative set of FDA-listed product records for Elafibranor — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 80 mg | Oral | Ipsen Biopharmaceuticals, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Elafibranor NDCs →
Elafibranor side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Elafibranor — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Elafibranor in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Elafibranor FDA approval history
How Elafibranor went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Elafibranor recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Elafibranor recalls since July 2021.
✅No Elafibranor recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2684941 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 2684945In current FDA listingsClinical drug / strength (SCD) 80 MGRxCUI 2684946
Look up RxCUI 2684941 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Elafibranor supply and shortage status
Whether Elafibranor is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Elafibranor brand names
Elafibranor is sold under one brand name in the FDA directory — Iqirvo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Elafibranor: manufacturers and labelers
One company lists Elafibranor products with the FDA. By number of product records, the largest are Ipsen Biopharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Elafibranor drug class (RxNorm)
Elafibranor belongs to the Peroxisome Proliferator-activated Receptor Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Elafibranor page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Ipsen Biopharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →