EMA · European Union
abatacept — EMA regulatory status
abatacept (ORENCIA) 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
- ORENCIA
- Originator
- Bristol-Myers Squibb Australia Pty Ltd
- Mechanism
- T-lymphocyte activation antigen CD80 inhibitor
- Target
- T-lymphocyte activation antigen CD80
- Structured fields
- 8
Sponsor / originator context: Bristol-Myers Squibb Australia Pty Ltd. 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: T-lymphocyte activation antigen CD80 inhibitor. Target: T-lymphocyte activation antigen CD80. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 10 published clinical programs and 12 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 |
|---|---|---|---|
| AB-01-004 | Phase 3 | Dr. Reddy's Laboratories | 2023-506664-14-00 |
| IM101-863 | Phase 3 | Bristol-Myers Squibb Australia | 2023-506450-20-00 |
| SMART-JIA | Phase 3 | George Institute for | 2025-520923-25-00 |
| Abatacept | Phase 2 | Ultragenyx UK | NCT00556439 |
| Abatacept | Phase 2 | Ultragenyx UK | NCT00468208 |
| Abatacept s.c. | Phase 2 | First People's Hospital | NCT04686929 |
| Abatacept | Phase 1 | Chinese Academy of | NCT04946669 |
| NORD-STAR | Approved | George Institute for | 2024-516723-14-00 |
| RC-P0055 | Approved | George Institute for | 2024-515600-39-00 |
| Re-JIA | Approved | Istituto Gentili Italia | 2024-514732-24-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12427137 | Method for reducing methane production in animal stomach | US |
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| 12234236 | GLP-1R agonist and therapeutic method thereof | US |
| 12226476 | Helper epitope peptide and application thereof | US |
| 12221414 | Quaternary ammonium salt compound, preparation method therefor and use thereof | US |
| 12144881 | Cosmetic composition containing α-mangostin, method for preparation, and uses thereof | US |
| 12110315 | Fish-derived peptidoglycan recognition protein mutant and application thereof | US |
| 12090227 | Method to improve the encapsulation efficiency and physicochemical stability of ginsenosides Rg3 and CK nano-emulsion | US |
Related hubs
FAQ
What is the EMA approval status of abatacept?
abatacept 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 abatacept 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 abatacept?
This spoke lists 10 published programs associated with abatacept in our pipeline index.