FDA · United States
upadacitinib — FDA regulatory status
upadacitinib (RINVOQ) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- RINVOQ
- Originator
- AbbVie
- Mechanism
- Tyrosine-protein kinase TYK2 inhibitor
- Structured fields
- 7
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 — FDA: approved.
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
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
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 FDA approval status of upadacitinib?
upadacitinib currently shows FDA approved in our United States regulatory index. Confirm on the official FDA 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.