NDAORALCAPSULEPriority Review
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Mechanism of Action
Ileal Bile Acid Transporter Inhibitors
Pharmacologic Class:
Ileal Bile Acid Transporter Inhibitor
Clinical Trials (5)
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Started Oct 2025
10 enrolled
Progressive Familial Intrahepatic Cholestasis
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Started Apr 2025
30 enrolled
Alagille Syndrome
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Started Sep 2023
20 enrolled
Pregnancy Related
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Started Jul 2022
180 enrolled
Biliary Atresia
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
Started Sep 2021
70 enrolled
Alagille Syndrome
Loss of Exclusivity
LOE Date
Nov 12, 2041
191 months away
Patent Expiry
Nov 12, 2041
Exclusivity Expiry
Jun 13, 2030
Company
Ipsen
China - Tianjin