EMA · European Union
fluticasone furoate — EMA regulatory status
fluticasone furoate (ARNUITY ELLIPTA) 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
- ARNUITY ELLIPTA
- Originator
- GlaxoSmithKline
- Mechanism
- Glucocorticoid receptor agonist
- Target
- Glucocorticoid receptor
- Structured fields
- 7
Sponsor / originator context: GlaxoSmithKline. 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: Glucocorticoid receptor agonist. Target: Glucocorticoid receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 8 published clinical programs and 0 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 |
|---|---|---|---|
| CPT for Allergic rhinoconjunctivitis to… | Phase 3 | Anaxis Pharma | 2025-521230-29-00 |
| Fluticasone furoate | Phase 3 | GSK Glaxo Smith | NCT01622231 |
| SAN-1138 | Phase 3 | Sandoz (Japan) | 2025-521565-27-00 |
| fluticasone furoate/vilanterol | Phase 3 | GSK Glaxo Smith | NCT01376245 |
| Fluticasone Furoate | Phase 2 | GSK Glaxo Smith | NCT01128569 |
| Fluticasone furoate (FF) (100 mcg) | Phase 2 | GSK Glaxo Smith | NCT02712047 |
| Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants | Phase 1 | MSD Merck Sharp | 2024-513069-37-00 |
| Avamys aqueous nasal spray 110mcg | Approved | GSK Glaxo Smith | NCT01270958 |
Related hubs
FAQ
What is the EMA approval status of fluticasone furoate?
fluticasone furoate 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 fluticasone furoate 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 fluticasone furoate?
This spoke lists 8 published programs associated with fluticasone furoate in our pipeline index.