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Bylvay

(Odevixibat)

Phase 3Small molecule

Bylvay is one of 21 small molecule programs targeting Biliary Atresia. It is currently in Phase 3.

3

Indications

5

Total Trials

2

Active Trials

20

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

16

Patents

Pipeline

Status by Indication[3][1]

Indication

Biliary AtresiaActive, not recruiting

Alagille SyndromeActive, not recruiting

Intrahepatic CholestasisActive, not recruiting

Biliary AtresiaPhase 3

Active, not recruiting

Alagille SyndromePhase 3

Active, not recruiting

Intrahepatic CholestasisPreclinical

Active, not recruiting

Competition

Competitive Landscape

24 competitors in Biliary Atresia

#DrugCompanyPhaseTrials

Anjeso

Boehringer Ingelheim

Acetadote

AArbor Pharmaceuticals, Inc.

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Bylvay

Neupogen

EEastern Cooperative Oncology Group

Trental

VValidus Pharmaceuticals

Immunoglobulin

Livmarli

MMirum Pharmaceuticals, Inc.

N-Acetyl Cyteien

SStanford University

Granulocyte Colony-Stimulating Factor

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Alagille Syndrome

NCT05035030

Clinical

Trials by Indication[1]

Biliary Atresia2 trials

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

Completed·AAlbireo, an Ipsen Company·Phase 3·NCT04336722·254 enrolled

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

Enrolling by invitation·AAlbireo, an Ipsen Company·Phase 3·NCT05426733·180 enrolled

Intrahepatic Cholestasis1 trial

Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

Approved for marketing·AAlbireo··NCT04483531

Efficacy and Safety1 trial

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

Completed·AAlbireo·Phase 3·NCT04674761·52 enrolled

Alagille Syndrome1 trial

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

Active, not recruiting·AAlbireo, an Ipsen Company·Phase 3·NCT05035030·62 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 20, 2021

BYLVAY

NDA NDA215498

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Odevixibat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Odevixibat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Odevixibat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215498). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Bylvay. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Ipsen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Ipsen

Patent Landscape[5]

Patent Cliff

Nov 8, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12187812Nov 8, 2031

11732006Nov 8, 2031

10487111Nov 8, 2031

10981952Nov 8, 2031

9694018Nov 8, 2031

11 more patents

10011633Nov 8, 2031

10093697Nov 8, 2031

12545705Nov 8, 2031

10975046Jun 20, 2039

12508234Jun 20, 2039

11802115Jun 20, 2039

12091394Jun 20, 2039

11365182Jun 20, 2039

11801226Jun 20, 2039

11583539Nov 12, 2041

12447156Nov 12, 2041

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