NDAORALTABLET
Approved
Apr 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
6/8 — Strong
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 2025.
Drug data last refreshed 9h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIVMARLI (maralixibat chloride) is an oral small molecule that inhibits the ileal bile acid transporter (IBAT) to decrease bile acid reabsorption in the terminal ileum. It is approved to treat cholestatic pruritus in pediatric patients with Alagille syndrome (ALGS) aged 3+ months and progressive familial intrahepatic cholestasis (PFIC) aged 12+ months. The mechanism reduces serum bile acids and alleviates severe itching, a debilitating symptom in these rare genetic liver diseases.
Growth17.2 years to LOE
Recently approved (April 2025) and in growth phase with market penetration opportunity in a rare disease niche; early-stage brand teams are building commercial infrastructure.
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.