TGA / PMDA / NMPA · Asia-Pacific
upadacitinib — TGA / PMDA / NMPA regulatory status
upadacitinib (RINVOQ) 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 · NMPA clinical trials.
Status snapshot
- Status
- TGA approved · NMPA clinical trials
- Brand
- RINVOQ
- Originator
- AbbVie
- Mechanism
- Tyrosine-protein kinase TYK2 inhibitor
- Structured fields
- 9
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: Tyrosine-protein kinase TYK2 inhibitor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — TGA: approved; NMPA: clinical trials.
Linked evidence on this spoke: 24 published clinical programs and 3 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
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| M14-533 | Phase 3 | AbbVie Deutschland GmbH | 2023-505699-31-00 |
| M14-671 | Phase 3 | AbbVie Deutschland GmbH | 2023-509618-12-00 |
| M14-682 | Phase 3 | AbbVie Deutschland GmbH | 2022-501599-25-00 |
| M16-852 | Phase 3 | AbbVie Deutschland GmbH | 2023-505476-29-00 |
| M17-380 | Phase 3 | AbbVie Deutschland GmbH | 2023-504713-76-00 |
| M23-716 | Phase 3 | AbbVie Deutschland GmbH | 2023-505061-82-01 |
| Matching Placebo for Upadacitinib | Phase 3 | AbbVie | NCT03345836 |
| Placebo to Upadacitinib | Phase 3 | AbbVie | NCT02706873 |
| Upadacitinib | Phase 3 | AbbVie | NCT05889182 |
| Upadacitinib | Phase 3 | AbbVie | NCT03738397, NCT04195698 |
| Upadacitinib | Phase 3 | AbbVie | NCT03345823, NCT03345849 |
| Upadacitinib | Phase 3 | AbbVie | NCT04169373 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025221754 | UPADACITINIB DESTINÉ À ÊTRE UTILISÉ DANS LE TRAITEMENT DE L'ARTÉRITE À CELLULES GÉANTES | WO |
| 2024398790 | TREATING SPONDYLOARTHRITIC CONDITIONS WITH UPADACITINIB | US |
| 2024390367 | METHODS OF TREATING VITILIGO WITH UPADACITINIB | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of upadacitinib?
upadacitinib currently shows TGA approved · NMPA clinical trials 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 upadacitinib 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 upadacitinib?
This spoke lists 24 published programs associated with upadacitinib in our pipeline index.