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Livmarli (maralixibat hydrochloride)
Livmarli (generic name: maralixibat hydrochloride) is a Ileal Bile Acid Transporter Inhibitor drug developed by Mirum Pharma Inc. It is currently FDA-approved (first approved 2021) for Cholestatic pruritus in Alagille syndrome, Cholestatic pruritus in PFIC.
Livmarli works by blocking the ileal sodium/bile acid cotransporter, which reduces the amount of bile acids reabsorbed into the bloodstream.
At a glance
| Generic name | maralixibat hydrochloride |
|---|---|
| Sponsor | Mirum Pharma Inc |
| Drug class | Ileal Bile Acid Transporter Inhibitor |
| Target | Ileal sodium/bile acid cotransporter |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Maralixibat is reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is common symptom in patients with ALGS and the pathophysiology of pruritus in patients with ALGS is not completely understood. Although the complete mechanism by which maralixibat improves pruritus in ALGS patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by decrease in serum bile acids [see Clinical Pharmacology (12.2)].
Approved indications
- Cholestatic pruritus in Alagille syndrome
- Cholestatic pruritus in PFIC
Common side effects
- Diarrhea
- Abdominal pain
- Vomiting
- Fat-Soluble Vitamin deficiency
- Liver test abnormalities
- Gastrointestinal bleeding
- Bone fractures
- Nausea
- Transaminases increased
- Increases to more than three times baseline in ALT
- AST increases to more than three times baseline
- Increases to more than five times baseline in ALT
Drug interactions
- Bile Acid Binding Resins (e.g., cholestyramine, colesevelam, colestipol)
- OATP2B1 Substrates (e.g., statins)
Key clinical trials
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Livmarli CI brief — competitive landscape report
- Livmarli updates RSS · CI watch RSS
- Mirum Pharma Inc portfolio CI
Frequently asked questions about Livmarli
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Related
- Drug class: All Ileal Bile Acid Transporter Inhibitor drugs
- Target: All drugs targeting Ileal sodium/bile acid cotransporter
- Manufacturer: Mirum Pharma Inc — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Cholestatic pruritus in Alagille syndrome
- Indication: Drugs for Cholestatic pruritus in PFIC
- Compare: Livmarli vs similar drugs
- Pricing: Livmarli cost, discount & access