FDA · United States
fluticasone furoate — FDA regulatory status
fluticasone furoate (ARNUITY ELLIPTA) 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
- 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 — FDA: 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 |
|---|---|---|---|---|
| FDA | United States | 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 FDA approval status of fluticasone furoate?
fluticasone furoate 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 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.