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Odevixibat FDA Approval Status

FDA Approved: No
Generic name: odevixibat
Company: Albireo Pharma, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis (PFIC)

Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) in development for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome.

Development Timeline for odevixibat

DateArticle
Dec  8, 2020Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC
Jul 14, 2020Albireo Enrolls First Patient in Phase 3 Clinical Trial of Odevixibat in Biliary Atresia

Further information

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