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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIVMARLI (maralixibat chloride) is an oral ileal bile acid transporter (IBAT) inhibitor approved for cholestatic pruritus in pediatric patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). It works by blocking bile acid reabsorption in the terminal ileum, reducing serum bile acids and alleviating pruritus, a debilitating symptom in these rare genetic cholestatic disorders.
$0.004BPart D
Peak13.8 years to LOEProduct is at peak commercial penetration in a rare disease niche with limited direct competition and modest Medicare spending, indicating a focused, specialized commercial team.
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.