NDAORALSOLUTIONPriority Review
Approved
Sep 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
8/8 — 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 17h 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, which reduces serum bile acid levels and alleviates pruritus, though the complete mechanism remains incompletely understood. This rare disease indication addresses a significant unmet need in hepatic cholestasis management.
$0.004BPart D
Peak13.3 years to LOEProduct is at peak lifecycle stage with established market presence; commercial team expansion likely stabilized after launch phase with focus on patient retention and indication expansion.
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.