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Maralixibat FDA Approval Status

FDA Approved: No
Generic name: maralixibat
Company: Mirum Pharmaceuticals, Inc.
Treatment for: Cholestatic Pruritus in Patients with Alagille Syndrome

Maralixibat is an inhibitor of the apical sodium dependent bile acid transporter (ASBT) in development for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).

Development Timeline for maralixibat

DateArticle
Mar 29, 2021Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
Feb  1, 2021Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome
Sep  1, 2020Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program
Dec 16, 2019Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat
Nov  8, 2019Mirum Pharmaceuticals Presents Data Demonstrating Long-term Durability of Treatment Effect of Maralixibat in Children With Cholestatic Liver Diseases
Oct 28, 2019Mirum Pharmaceuticals Announces Breakthrough Therapy Designation for Maralixibat for the Treatment of Pruritus Associated with Alagille Syndrome
Jul  9, 2019Mirum Pharmaceuticals Initiates Phase 3 Clinical Trial of Maralixibat for Pediatric Patients with Progressive Familial Intrahepatic Cholestasis

Further information

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