NDAORALCAPSULEPriority Review
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
7/8 — Comprehensive
Priority Review
BYLVAY (odevixibat) by Ipsen is ileal bile acid transporter inhibitors [moa]. Approved for ileal bile acid transporter inhibitor [epc]. First approved in 2021.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYLVAY (odevixibat) is an oral ileal bile acid transporter inhibitor approved in 2021 for rare pediatric cholestatic liver diseases including biliary atresia, Alagille syndrome, and progressive familial intrahepatic cholestasis. It works by blocking bile acid reabsorption in the ileum, reducing circulating bile acids and pruritus. The drug addresses a critical unmet need in ultra-rare pediatric hepatology where treatment options are severely limited.
$3MPart D
Peak15.5 years to LOEEarly-stage peak revenue with minimal Part D penetration suggests a niche specialty product with small commercial infrastructure and limited team expansion potential.
Mechanism of Action
Ileal Bile Acid Transporter Inhibitors
Pharmacologic Class:
Ileal Bile Acid Transporter Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Retrospective Observational Study of Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
Started Apr 2026
200 enrolled
PFIC - Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Started Oct 2025
10 enrolled
Progressive Familial Intrahepatic Cholestasis
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Started Apr 2025
30 enrolled
Alagille Syndrome
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Started Sep 2023
20 enrolled
Pregnancy Related
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Started Jul 2022
180 enrolled
Biliary Atresia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.