EMA · European Union
odevixibat — EMA regulatory status
odevixibat (BYLVAY) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- BYLVAY
- Originator
- Ipsen
- Mechanism
- Ileal bile acid transporter inhibitor
- Target
- Ileal sodium/bile acid cotransporter
- Structured fields
- 7
Sponsor / originator context: Ipsen. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Ileal bile acid transporter inhibitor. Target: Ileal sodium/bile acid cotransporter. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 2 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| A4250-015 | Phase 3 | Ipsen | 2023-509028-17-00 |
| Odevixibat | Phase 3 | Ipsen | NCT05426733 |
Related hubs
FAQ
What is the EMA approval status of odevixibat?
odevixibat currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get odevixibat regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to odevixibat?
This spoke lists 2 published programs associated with odevixibat in our pipeline index.