NDAORALSOLUTIONPriority Review
Approved
Sep 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
Priority Review
LIVMARLI (maralixibat chloride) by Mirum Pharmaceuticals is (ibat). Approved for cholestatic pruritus in patients 3 months of age, older with alagille syndrome (algs), cholestatic pruritus in patients 12 months of age and 1 more indications. First approved in 2021.
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIVMARLI (maralixibat chloride) is an oral ileal bile acid transporter (IBAT) inhibitor approved to treat cholestatic pruritus in pediatric patients with Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis (PFIC). It works by decreasing bile acid reabsorption in the terminal ileum, thereby reducing serum bile acid levels and alleviating pruritus. The exact mechanism of pruritus relief is not fully understood but appears linked to IBAT inhibition and altered bile acid metabolism.
$0.004BPart D
Peak13.5 years to LOELIVMARLI is at peak lifecycle stage with minimal current Part D claims, suggesting a niche pediatric rare-disease position with focused commercial team structures.
Mechanism of Action
(IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum . Pruritus is a common symptom in patients with ALGS or PFIC and the pathophysiology of pruritus in patients with ALGS or PFIC is not completely understood. Although the complete mechanism by…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.