NDAORALCAPSULEPriority Review
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
8/8 — 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 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYLVAY (odevixibat) is an oral small-molecule ileal bile acid transporter (IBAT) inhibitor approved in July 2021 for progressive familial intrahepatic cholestasis (PFIC). It works by blocking bile acid reabsorption in the ileum, reducing circulating bile acids and alleviating pruritus and cholestasis associated with rare liver diseases.
$0.003BPart D
Peak15.1 years to LOEProduct is at peak lifecycle stage with modest Part D utilization (26 claims in 2023), indicating niche market penetration and stable but small commercial team.
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 (11)
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Started Jul 2026
30 enrolled
Alagille Syndrome
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 China
Started Apr 2026
20 enrolled
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
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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.