Odevixibat
- Generic Name
- Odevixibat
- Brand Names
- Bylvay, 蓓尔唯
- Drug Type
- Small Molecule
- Chemical Formula
- C37H48N4O8S2
- CAS Number
- 501692-44-0
- Unique Ingredient Identifier
- 2W150K0UUC
- Background
Odevixibat, or A4250, is an ileal sodium/bile acid cotransporter inhibitor indicated for the treatment of pruritus in patients older than 3 months, with progressive familiar intrahepatic cholestasis (PFIC). Odevixibat is the first approved non-surgical treatment option for PFIC. Previous therapies for PFIC included a bile acid sequestrant such as ursodeoxycholic acid.
Odevixibat was granted FDA approval on 20 July 2021.
- Indication
Odevixibat is indicated for the treatment of pruritus in patients older than 3 months with progressive familiar intrahepatic cholestasis (PFIC) and cholestatic pruritus in patients 12 months of age and older with Alagille Syndrome. It may not be effective in patients with PFIC type 2 with ABCB11 variants since these patients lack a functional bile salt export pump.
- Associated Conditions
- Cholestatic pruritus, Pruritus
- Associated Therapies
- -
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
- First Posted Date
- 2022-06-22
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Albireo, an Ipsen Company
- Target Recruit Count
- 180
- Registration Number
- NCT05426733
- Locations
- 🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸Indiana University school of Medicine, Indianapolis, Indiana, United States
🇺🇸Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
- First Posted Date
- 2021-09-05
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Albireo, an Ipsen Company
- Target Recruit Count
- 70
- Registration Number
- NCT05035030
- Locations
- 🇺🇸
Texas Liver Institute, San Antonio, Texas, United States
🇺🇸UCSF, San Francisco, California, United States
🇺🇸University of California San Francisco (UCSF), San Francisco, California, United States
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
- First Posted Date
- 2020-12-19
- Last Posted Date
- 2023-11-02
- Lead Sponsor
- Albireo
- Target Recruit Count
- 52
- Registration Number
- NCT04674761
- Locations
- 🇫🇷
Antenne pédiatrique du CIC - Hopital Jeanne De Flandre, Lille, France
🇫🇷Hopital Necker Enfants Malades, Paris, France
🇹🇷Istanbul University Medical Faculty Hospital, Fatih, Turkey
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
- First Posted Date
- 2020-07-23
- Last Posted Date
- 2024-03-07
- Lead Sponsor
- Albireo
- Registration Number
- NCT04483531
- Locations
- 🇺🇸
Albireo Pharma Inc., Boston, Massachusetts, United States
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
- First Posted Date
- 2020-04-07
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Albireo, an Ipsen Company
- Target Recruit Count
- 254
- Registration Number
- NCT04336722
- Locations
- 🇺🇸
Children's Healthcare of Atlanta - Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸Johns Hopkins Children's Center, Baltimore, Maryland, United States
🇺🇸Seattle Children's Hospital, Seattle, Washington, United States
Drug Development Updates
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