Wednesday, July 8, 2026

Drug profile · INN

odevixibat

odevixibat (BYLVAY) is a ileal bile acid transporter inhibitor. Associated with Ipsen. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Alimentary tract and metabolism (A05) A05AX
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — odevixibat
US status
approved
Class
Alimentary tract and metabolism (A05)
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

odevixibat (BYLVAY) is a ileal bile acid transporter inhibitor. Associated with Ipsen. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN odevixibat
Brand BYLVAY
Mechanism Ileal bile acid transporter inhibitor
Target Ileal sodium/bile acid cotransporter
Therapeutic class Alimentary tract and metabolism (A05)
Route ORAL
Formulation CAPSULE
ATC code A05AX
Originator Ipsen

Mechanism of action

Ileal bile acid transporter inhibitor

Primary target: Ileal sodium/bile acid cotransporter

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. A4250-015 Phase 3 · Ipsen · Alagille Syndrome
  2. Odevixibat Phase 3 · Ipsen · Biliary Atresia

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is odevixibat?

odevixibat (BYLVAY) is a ileal bile acid transporter inhibitor. Associated with Ipsen. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for odevixibat?

BYLVAY is a marketed brand name for odevixibat. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of odevixibat?

odevixibat has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.