Back to discover
Drug

Odevixibat

Approved · EMA
Late-stage development

Also known as Bylvay.

RxNorm2563966ChEMBLCHEMBL4297588UNII2W150K0UUC
2
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)

Clinical trial2026-07-02Results expected Q4 2026 · ClinicalTrials.gov

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)

Clinical trial2026-07-02Results expected Q2 2028 · ClinicalTrials.gov

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 Hepatoportoenterostomy

Clinical trial2026-06-22Completed · ClinicalTrials.gov

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

Clinical trial2023-11-02Results posted · ClinicalTrials.gov

Accelerated approval: Bylvay (EMA)

Regulatory2021-07-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Odevixibat
Aliases & brands
Bylvay
RxNorm CUI
2563966
ChEMBL ID
CHEMBL4297588
UNII
2W150K0UUC
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-07-16
Latest approval
2021-07-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-07-16Accelerated approval
Accelerated approval: Bylvay (EMA)

Indication: Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

4 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
4
registered trials across all phases
LATEST COMPLETION 2026
2
Active studies
1
Recruiting
4
Late-stage (III+)
2
Completed
PHASE DISTRIBUTIONn = 4
Phase 34

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)

Enrolling by invitationPH IIIAlbireo, an Ipsen Companyn=1802028

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)

Active, not recruitingPH IIIAlbireo, an Ipsen Companyn=622026

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 Hepatoportoenterostomy

CompletedPH IIIAlbireo, an Ipsen Companyn=2542026

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

CompletedPH IIIAlbireon=522022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.