Product
Odevixibat
Aliases
A4250
Name
BYLVAY
INN Name
odevixibat
FDA Approved
Yes
5 clinical trials
2 organizations
3 indications
1 document
Indication
Biliary AtresiaIndication
Alagille syndromeClinical trial
Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Access Program)Status:
Clinical trial
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai HepatoportoenterostomyStatus: Recruiting, Estimated PCD: 2026-06-30
Clinical trial
An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)Status: Active (not recruiting), Estimated PCD: 2024-02-07
Clinical trial
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)Status: , Estimated PCD: 2024-12-31
Clinical trial
A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)Status: Completed, Estimated PCD: 2022-09-09
Document
DailyMed Label: BYLVAYOrganization
Albireo Pharma, Inc.Organization
Ipsen Biopharmaceuticals, Inc.