NDAORALSOLUTIONPriority Review
Approved
Sep 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
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…
Clinical Trials (2)
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome in the European Union (LEAP-EU)
Started Sep 2025
100 enrolled
Alagille Syndrome
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
Started Sep 2023
70 enrolled
Alagille SyndromeProgressive Familial Intrahepatic Cholestasis
Loss of Exclusivity
LOE Date
Feb 12, 2040
169 months away
Patent Expiry
Feb 12, 2040
Exclusivity Expiry
Jul 24, 2031