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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

Overview

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.

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

FDA Approved Products

BYLVAY
Manufacturer:Albireo Pharma, Inc.
Route:ORAL
Strength:600 ug in 1 1
Approved: 2023/06/15
NDC:74528-060
BYLVAY
Manufacturer:Albireo Pharma, Inc.
Route:ORAL
Strength:1200 ug in 1 1
Approved: 2023/06/15
NDC:74528-120
BYLVAY
Manufacturer:Albireo Pharma, Inc.
Route:ORAL
Strength:400 ug in 1 1
Approved: 2023/06/15
NDC:74528-040
BYLVAY
Manufacturer:Albireo Pharma, Inc.
Route:ORAL
Strength:200 ug in 1 1
Approved: 2023/06/15
NDC:74528-020

Singapore Approved Products

No Singapore products found for this drug

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