EMA · European Union
filgotinib — EMA regulatory status
filgotinib (JYSELECA) 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
- JYSELECA
- Mechanism
- Tyrosine-protein kinase JAK3 inhibitor
- Target
- Tyrosine-protein kinase JAK1
- Structured fields
- 7
Pharmacology context used for competitive intelligence: Tyrosine-protein kinase JAK3 inhibitor. Target: Tyrosine-protein kinase JAK1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 24 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
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Filgotinib | Phase 3 | Lakefront Biotherapeutics NV | NCT02914561, NCT02914600 |
| Filgotinib | Phase 3 | Lakefront Biotherapeutics NV | NCT02914522, NCT05479058 |
| Filgotinib | Phase 3 | Lakefront Biotherapeutics NV | NCT03101670, NCT03320876 |
| Filgotinib | Phase 3 | Lakefront Biotherapeutics NV | NCT03117270, NCT04483687 |
| Filgotinib | Phase 3 | Alfasigma | NCT05785611 |
| GLPG0634-CL-329 | Phase 3 | Alfasigma | 2024-511593-70-00 |
| GLPG0634-CL-331 | Phase 3 | Alfasigma | 2024-511458-32-00 |
| GLPG0634-CL-333 | Phase 3 | Alfasigma | 2025-523239-21-00 |
| GS-US-417-0304 | Phase 3 | Alfasigma | 2024-513919-27-00 |
| GS-US-418-3899 | Phase 3 | Alfasigma | 2024-516199-14-00 |
| Filgotinib | Phase 2 | Lakefront Biotherapeutics NV | NCT03207815 |
| Filgotinib | Phase 2 | Lakefront Biotherapeutics NV | NCT03077412 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026027669 | BIOMARQUEURS POUR DÉTERMINER LE TRAITEMENT DE LA RECTOCOLITE HÉMORRAGIQUE AVEC DU FILGOTINIB | WO |
Related hubs
FAQ
What is the EMA approval status of filgotinib?
filgotinib 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 filgotinib 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 filgotinib?
This spoke lists 24 published programs associated with filgotinib in our pipeline index.