TGA / PMDA / NMPA · Asia-Pacific
fluticasone furoate — TGA / PMDA / NMPA regulatory status
fluticasone furoate (ARNUITY ELLIPTA) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: TGA approved.
Status snapshot
- Status
- TGA 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 — TGA: 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 |
|---|---|---|---|---|
| TGA | Australia | 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 TGA / PMDA / NMPA approval status of fluticasone furoate?
fluticasone furoate currently shows TGA approved in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA 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.