Maralixibat
Maralixibat is an ileal bile acid transporter (IBAT) inhibitor used to treat cholestatic pruritus (intense itching from bile flow problems in the liver) in people with Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC).
🧬 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 →
Maralixibat (Livmarli), a specialist medicine on the market since about 2021, eases cholestatic pruritus (itching from bile buildup) in Alagille syndrome and PFIC (progressive familial intrahepatic cholestasis), two inherited liver conditions, by blocking the gut transporter that recycles bile acids. Diarrhea and belly pain are what people notice most (vomiting is more common in Alagille syndrome), and the dose is built up gradually. The main concern is drug-induced liver injury, occasionally serious, so liver tests are checked before starting and often during the early months. It also cuts absorption of vitamins A, D, E and K, and low levels can cause fractures or bleeding, so expect regular vitamin checks.
Clinical pearls
- Give it 30 minutes before a meal, once each morning for Alagille syndrome or twice daily for PFIC.
- If cholestyramine, colesevelam or colestipol is also prescribed, take maralixibat at least 4 hours before or after it.
- For children under 5 on the oral solution, measure every dose exactly, because the liquid contains propylene glycol.
- Get help right away for vomiting blood, a swelling belly or new confusion, which can signal serious liver trouble.
Patient information guide A plain-language walkthrough of Maralixibat, written from its FDA label.
What Maralixibat is used for
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Maralixibat (Livmarli) treats cholestatic pruritus in two inherited liver conditions:
- Alagille syndrome (ALGS): patients 3 months of age and older.
- Progressive familial intrahepatic cholestasis (PFIC): patients 12 months of age and older.
- Not recommended for a subgroup of PFIC type 2 patients with specific ABCB11 variants causing non-functional or absent BSEP protein.
How Maralixibat works
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Maralixibat blocks the ileal bile acid transporter, a protein in the last part of the small intestine. This protein normally recycles bile acids back into the body. Blocking it lowers bile acid reabsorption, and blood bile acid levels fell in studies.
How this relieves itching is not completely understood.
Maralixibat dosage
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Livmarli is taken by mouth 30 minutes before a meal, as either an oral solution or a tablet. Tablets are an option for patients weighing 25 kg or more who can swallow them.
- Alagille syndrome: once daily in the morning.
- PFIC: twice daily.
- Dosing starts low and is increased as tolerated.
- Missed once-daily dose: take it within 12 hours of the usual time. Otherwise skip it and resume your schedule.
- Missed twice-daily dose: take it within 6 hours of the usual time. Otherwise skip it and resume your schedule.
Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Maralixibat 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.
- Alagille syndrome (ALGS)
- Recommended dosage is 380 mcg/kg once daily, taken 30 minutes before a meal in the morning
- Start at 190 mcg/kg orally once daily
- After one week, increase to 380 mcg/kg once daily, as tolerated
- Use LIVMARLI Oral Solution 9.5 mg/mL or LIVMARLI Tablets
- Maximum: 28.5 mg (3 mL) per day for oral solution and 30 mg per day for tablets
- Tablets for patients weighing 25 kg and above who can swallow tablets; patients less than 25 kg use oral solution
- Progressive familial intrahepatic cholestasis (PFIC)
- Recommended dosage is 570 mcg/kg twice daily 30 minutes before a meal
- Start at 285 mcg/kg orally once daily in the morning, increase to 285 mcg/kg twice daily, 428 mcg/kg twice daily, and then to 570 mcg/kg twice daily, as tolerated
- Use LIVMARLI Oral Solution 19 mg/mL or LIVMARLI Tablets
- Maximum: 38 mg (2 mL) per day for oral solution and 40 mg per day for tablets
- The 9.5 mg/mL and 19 mg/mL strengths should not be substituted for one another; tablets for patients weighing 25 kg and above who can swallow tablets; accurate dose volume calculation is especially important for patients less than 5 years old (propylene glycol excipient)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Use LIVMARLI Oral Solution 9.5 mg/mL for treatment of ALGS. ( 2.1 ) • Use LIVMARLI Oral Solution 19 mg/mL for treatment of PFIC. ( 2.1 ) • LIVMARLI Tablets can be used for treatment of both ALGS and PFIC in patients weighing 25 kg and above who can swallow tablets. ( 2.1 ) ALGS: ○ The recommended dosage is 380 mcg/kg once daily, taken 30 minutes before a meal in the morning. ○ Starting dose is 190 mcg/kg orally once daily,and should be increased to 380 mcg/kg daily after one week, as tolerated and not to exceed a maximum daily dose of 28.5 mg per day for the oral solution and 30 mg per day for the tablets. ( 2.2 ) PFIC: ○ The recommended dosage is 570 mcg/kg twice daily before a meal. ○ Starting dose is 285 mcg/kg orally once daily in the morning and should be increased to 285 mcg/kg twice daily, 428 mcg/kg twice daily, and then to 570 mcg/kg twice daily, as tolerated and not to exceed a maximum daily dose of 38 mg per day for the oral solution and 40 mg per day for the tablets. ( 2.3 ) • See full prescribing information for additional dosage details for LIVMARLI oral solution and tablet formulations. ( 2.2 , 2.3 ) 2.1 Important Administration Information • Use LIVMARLI Oral Solution 9.5 mg/mL for treatment of ALGS. • Use LIVMARLI Oral Solution 19 mg/mL for treatment of PFIC. • The two strengths of LIVMARLI Oral Solution, 9.5 mg/mL and 19 mg/mL, should not be substituted for one another when treating PFIC patients [see Dosage and Administration (2.3) ]. • LIVMARLI tablets can be used for treatment of both ALGS and PFIC in patients weighing 25 kg and above who can swallow tablets. Select LIVMARLI Oral Solution or LIVMARLI Tablets based on the patient's weight and ability to swallow tablets [see Dosage and Administration (2.2 , 2.3 )]. 2.2 Recommended Dosage for Alagille Syndrome Use LIVMARLI Oral Solution 9.5 mg/ mL or LIVMARLI Tablets for the treatment of ALGS . The recommended dosage is 380 mcg/kg once daily, taken 30 minutes before a meal in the morning. Start dosing at 190 mcg/kg administered orally once daily; after one week, increase to 380 mcg/kg once daily, as tolerated. The maximum daily dose should not exceed 28.5 mg (3 mL) per day for LIVMARLI Oral solution and 30 mg per day for LIVMARLI tablets. Refer to the dosage by weight guidelines presented in Table 1 for LIVMARLI Oral Solution and Table 2 for LIVMARLI tablets.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Maralixibat side effects
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The most common side effects are:
Common side effects
- Diarrhea
- Abdominal pain
- Vomiting (most often in Alagille syndrome)
- Fat-soluble vitamin deficiency
- Liver test abnormalities
- Bone fractures
- Blood in the stool (hematochezia, in PFIC)
When to get medical help
- Call your doctor if you notice signs of liver problems, such as new liver test changes or signs of hepatitis. Liver injury can be serious.
- Get help right away for signs of liver decompensation, such as vomiting blood (variceal bleeding), fluid buildup in the belly (ascites) or confusion (hepatic encephalopathy).
- Call your doctor for diarrhea that won't go away, ongoing belly pain, bloody stool, vomiting, dehydration or fever.
- Report any bleeding or a bone fracture. These can be linked to low fat-soluble vitamins.
- In children under 5 taking the oral solution, watch for signs of propylene glycol toxicity, such as breakdown of red blood cells, kidney injury or effects on the brain and nervous system.
Maralixibat warnings and precautions
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- Liver injury: Liver tests are checked before starting and often in the first 6 to 8 months. Treatment may be paused or stopped permanently if problems occur.
- Liver decompensation: Stop permanently if it occurs.
- Digestive problems: Persistent diarrhea or belly pain may need a lower dose or a pause.
- Low vitamins A, D, E and K: This can lead to fractures or bleeding. Levels are monitored and supplements given.
- Propylene glycol: The oral solution contains it, and children under 5 are at highest risk.
Maralixibat interactions
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A few drugs need attention with maralixibat:
- Bile acid binding resins (cholestyramine, colesevelam, colestipol): they can bind maralixibat, so separate doses by at least 4 hours.
- Statins and other OATP2B1 substrates: absorption may decrease, so your doctor may monitor their effects.
Interactions listed in the FDA-approved label
From the Maralixibat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol): Bile acid binding resins may bind to maralixibat in the gut. Administer LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins.
- OATP2B1 substrates (e.g., statins): Maralixibat is an OATP2B1 inhibitor based on in vitro studies; a decrease in the oral absorption of OATP2B1 substrates due to OATP2B1 inhibition in the GI tract cannot be ruled out. Consider monitoring the drug effects of OATP2B1 substrates (e.g., statins) as needed.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Bile Acid Sequestrants: Modify LIVMARLI administration schedule. ( 7.1 ) 7.1 Effects of Other Drugs on LIVMARLI Bile Acid Binding Resins Bile acid binding resins may bind to maralixibat in the gut. Administer LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol). 7.2 Effects of LIVMARLI on Other Drugs OATP2B1 substrates Maralixibat is an OATP2B1 inhibitor based on in vitro studies. A decrease in the oral absorption of OATP2B1 substrates (e.g., statins) due to OATP2B1 inhibition in the GI tract cannot be ruled out. Consider monitoring the drug effects of OATP2B1 substrates (e.g. statins) as needed [see Clinical Pharmacology (12.3) ] .
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 Maralixibat
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- Do not use if you have had liver decompensation (variceal bleeding, ascites, hepatic encephalopathy).
- Tell your doctor about cirrhosis, chronic diarrhea or low vitamin levels.
- Pregnancy: little drug reaches the baby, but vitamins may need to be increased.
- Breastfeeding: little drug is expected to reach the infant, and vitamin levels should be monitored.
- Children under 5 on the oral solution need careful dose calculation because of propylene glycol.
Maralixibat overdose
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Single doses up to 500 mg were tolerated in healthy adults without a meaningful increase in side effects. After an overdose, stop Livmarli, watch for symptoms and get supportive care. Because the product contains propylene glycol, watch for toxicity signs and stop if suspected.
What Maralixibat does in the body
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In studies of children with Alagille syndrome and PFIC, serum bile acid levels fell in most patients. The drop was seen as early as week 12 in Alagille syndrome and week 2 in PFIC. It was generally maintained during treatment.
How your body processes Maralixibat
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Very little maralixibat is absorbed into the blood, so levels are often too low to measure. It acts locally in the gut. Taking it with a high-fat meal lowered absorption, which is why it is given before meals. The half-life was about 1.6 hours in healthy adults. The tablet gives slightly lower exposure than the oral solution, which is not clinically meaningful.
How to store Maralixibat
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Store unopened LIVMARLI oral solution and tablets between 20°C and 25°C (68°F and 77°F), excursion permitted between 15°C and 30°C (59°F and 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Maralixibat
17 supplements and herbal products have documented interactions with Maralixibat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Maralixibat: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Maralixibat — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How do I take it?
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What if I miss a dose?
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What side effects should I expect?
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Do I need any monitoring?
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Does it interact with other medicines?
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Is Maralixibat available over the counter?
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When was Maralixibat 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 Maralixibat on HelloPharmacist
Maralixibat forms and strengths (how it comes)
Maralixibat is available in 2 forms. 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Maralixibat inactive ingredients by manufacturer.
Oral solution
How this form is used
- Livmarli Oral Solution 9.5 mg/mL is the strength used for Alagille syndrome.
- Livmarli Oral Solution 19 mg/mL is the strength used for PFIC.
- Livmarli Oral Solution is taken 30 minutes before a meal, measured with the oral dosing dispenser the pharmacy provides.
- The two Livmarli Oral Solution strengths should not be substituted for one another in PFIC.
- Livmarli Oral Solution should be discarded 100 days after opening.
Tablet
How this form is used
- Livmarli Tablets can be used for both Alagille syndrome and PFIC in patients weighing 25 kg or more who can swallow tablets.
- Livmarli Tablets are taken 30 minutes before a meal.
- Patients under 25 kg use the Livmarli Oral Solution instead of the tablets.
Maralixibat on the U.S. market: products, makers and brands
How Maralixibat 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 6 Maralixibat product records with the FDA, mostly as oral solution, tablet; the earliest marketing or approval year on record is 2021. Brand names on the directory include Livmarli; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Maralixibat is used (Medicaid data)
A general measure of how commonly Maralixibat 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 Maralixibat 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 Maralixibat prescribed? Of the 1,601 medications we measure, Maralixibat ranks #1,264 by Medicaid prescriptions — more than 21% of them.
Utilization by Maralixibat 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.
maralixibat 9.5 MG/ML Oral Solution Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2571079
maralixibat 20 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 2712469
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 Maralixibat, 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 2 of 2 listed Maralixibat NDCs with Medicaid activity.
Compare Maralixibat products
A representative set of FDA-listed product records for Maralixibat — 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 |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 9.5 mg/mL | Oral | Mirum Pharmaceuticals Inc. | NDA | View NDC → |
| 19 mg/mL | Oral | Mirum Pharmaceuticals Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 10 mg | Oral | Mirum Pharmaceuticals Inc. | NDA | View NDC → |
| 15 mg | Oral | Mirum Pharmaceuticals Inc. | NDA | View NDC → |
| 20 mg | Oral | Mirum Pharmaceuticals Inc. | NDA | View NDC → |
| 30 mg | Oral | Mirum Pharmaceuticals Inc. | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Maralixibat NDCs →
Maralixibat 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 Maralixibat — 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 Maralixibat 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.
Maralixibat FDA approval history
How Maralixibat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Maralixibat 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 Maralixibat recalls since July 2021.
✅No Maralixibat 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 2571074 2 dose forms · 6 strengths
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Dose form (SCDF) Oral Solution RxCUI 2571078In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 2712462In current FDA listings
Look up RxCUI 2571074 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.
Maralixibat supply and shortage status
Whether Maralixibat 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.
Maralixibat brand names
Maralixibat is sold under one brand name in the FDA directory — Livmarli. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Maralixibat: manufacturers and labelers
One company lists Maralixibat products with the FDA. By number of product records, the largest are Mirum Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Maralixibat drug class (RxNorm)
Maralixibat belongs to the Ileal Bile Acid Transporter Inhibitor 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 Maralixibat 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. Mirum Pharmaceuticals 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 →