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Last Updated: December 16, 2025

Claims for Patent: 11,497,745

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Summary for Patent: 11,497,745

Title:	Methods for treating cholestasis
Abstract:	Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
Inventor(s):	Thomas JAECKLIN, Alejandro Dorenbaum
Assignee:	Mirum Pharmaceuticals Inc
Application Number:	US17/554,588
Patent Claims:	1. A method for treating Alagille Syndrome (ALGS) in a subject in need of such treatment comprising administering to the subject maralixibat in an amount of from 360 μg/kg/day to 880 μg/kg/day. 2. The method of claim 1, wherein maralixibat is administered in an amount of 360 μg/kg/day to 440 μg/kg/day. 3. The method of claim 1, wherein maralixibat is administered once daily (QD). 4. The method of claim 1, wherein maralixibat is administered twice daily (BID). 5. The method of claim 1, wherein maralixibat is administered for at least 18 weeks. 6. The method of claim 1, wherein maralixibat is administered for at least 2 years. 7. The method of claim 1, wherein maralixibat is administered for at least 3 years. 8. The method of claim 1, wherein the subject exhibits below normal height or weight prior to the administration of maralixibat. 9. The method of claim 1, wherein the subject experiences pruritus prior to the administration of maralixibat. 10. The method of claim 1, wherein the subject is a pediatric subject. 11. The method of claim 1, wherein the subject is at least 1 year of age. 12. The method of claim 1, wherein maralixibat is administered prior to ingestion of food. 13. The method of claim 1, wherein maralixibat is administered orally.

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