TGA / PMDA / NMPA · Asia-Pacific
odevixibat — TGA / PMDA / NMPA regulatory status
odevixibat (BYLVAY) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: TGA approved.
Status snapshot
- Status
- TGA 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 — TGA: 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 |
|---|---|---|---|---|
| TGA | Australia | 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 TGA / PMDA / NMPA approval status of odevixibat?
odevixibat currently shows TGA approved in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA 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.