TGA / PMDA / NMPA · Asia-Pacific
risankizumab — TGA / PMDA / NMPA regulatory status
risankizumab (SKYRIZI) 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 · PMDA approved.
Status snapshot
- Status
- TGA approved · PMDA approved
- Brand
- SKYRIZI
- Originator
- AbbVie
- Mechanism
- Interleukin-23 inhibitor
- Target
- Interleukin-23
- Structured fields
- 10
Sponsor / originator context: AbbVie. 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: Interleukin-23 inhibitor. Target: Interleukin-23. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — TGA: approved; PMDA: approved.
Linked evidence on this spoke: 23 published clinical programs and 1 related patent record. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| M1095-PSA-302 | Phase 3 | MoonLake Immunotherapeutics | 2024-516219-25-00 |
| M15-998 | Phase 3 | AbbVie Deutschland GmbH | 2023-505477-33-00 |
| M16-000 | Phase 3 | AbbVie Deutschland GmbH | 2023-506399-28-00 |
| M16-011 | Phase 3 | AbbVie Deutschland GmbH | 2023-505478-14-00 |
| M16-066 | Phase 3 | AbbVie Deutschland GmbH | 2023-506994-36-00 |
| M16-194 | Phase 3 | AbbVie Deutschland GmbH | 2022-502050-14-00 |
| M19-751 | Phase 3 | AbbVie Deutschland GmbH | 2024-514695-41-00 |
| M23-732 | Phase 3 | AbbVie Deutschland GmbH | 2023-506026-36-00 |
| M25-540 | Phase 3 | AbbVie Deutschland GmbH | 2024-518998-33-00 |
| PA0016 | Phase 3 | Anaxis Pharma | 2024-511738-11-00 |
| Placebo for risankizumab, ABBV-066 | Phase 3 | AbbVie Deutschland GmbH | 2024-516023-13-00 |
| Risankizumab | Phase 3 | AbbVie | NCT04451720 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025137347 | FORMULATIONS DE RISANKIZUMAB À HAUTE CONCENTRATION | WO |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of risankizumab?
risankizumab currently shows TGA approved · PMDA 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 risankizumab 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 risankizumab?
This spoke lists 23 published programs associated with risankizumab in our pipeline index.