NCT01622231
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported in available sources
pharma · Asthma · Respiratory Syncytial Virus Infections
GSK Glaxo Smith
GlaxoSmithKline
GSK Glaxo Smith is a pharma organization headquartered in SAINT-AMAND LES EAUX, FR. Primary therapeutic focus areas include Asthma, Respiratory Syncytial Virus Infections, Hepatitis B, Chronic, Neoplasms, Influenza. Nova
637 r Aulnois, Saint Amand les Eaux, 59 59230, FR, SAINT-AMAND LES EAUX HQ
30 Employees
NMPA registrant Type
Company details
- Status
- Public
- HQ
- 637 r Aulnois, Saint Amand les Eaux, 59 59230, FR, SAINT-AMAND LES EAUX
- Employees
- 30
- Programs
- 205
- Drugs
- 194
- Patents
- 0
Fluticasone furoate
Phase 3 · small molecule · Rhinitis
Fluticasone furoate (ARNUITY ELLIPTA) is a small-molecule intranasal corticosteroid developed by GlaxoSmithKline for the treatment of rhinitis. The drug is administered via nasal spray delivery and belongs to the respiratory system therapeutic class (R03). The program has completed Phase 3 clinical development, with th
Internal code 116365
At a glance
- Sponsor
- GlaxoSmithKline
- Phase
- Phase 3
- Modality
- small_molecule
- Indication
- Rhinitis
- Status
- completed
- Trials
- 1
Executive summary
Fluticasone furoate (ARNUITY ELLIPTA) is a small-molecule intranasal corticosteroid developed by GlaxoSmithKline for the treatment of rhinitis. The drug is administered via nasal spray delivery and belongs to the respiratory system therapeutic class (R03). The program has completed Phase 3 clinical development, with the most recent milestone recorded on January 9, 2017. Fluticasone furoate has achieved regulatory approval across multiple major markets: the United States (via multiple NDA applications including NDA022051, NDA204275, NDA205625, and NDA209482), the European Union (with seven EMA product numbers and authorisation dates ranging from June 2025 to May 2026), and Australia (with PBS listing codes and first listing dates from August 2019 onwards). The regulatory status indicates the program has transitioned from clinical development to commercialization, with GSK maintaining marketing authorization across key geographies. The competitive landscape includes multiple approved respiratory therapies, though fluticasone furoate's intranasal formulation and corticosteroid mechanism position it within the rhinitis treatment segment.
Why this program matters
Rhinitis represents a significant unmet medical need affecting millions of patients globally, with allergic rhinitis alone impacting approximately 10-30% of the population in developed countries. Intranasal corticosteroids remain first-line pharmacological therapy for moderate-to-severe allergic rhinitis, addressing symptoms including nasal congestion, rhinorrhea, and pruritus. Fluticasone furoate's approval across the US, EU, and Australia demonstrates commercial validation in major pharmaceutical markets, with PBS listing in Australia indicating health economic recognition. The drug competes within a crowded rhinitis and respiratory market that includes multiple corticosteroid formulations and combination therapies. Patient population encompasses both seasonal and perennial allergic rhinitis sufferers, representing a substantial commercial opportunity given high disease prevalence and chronic treatment requirements. GSK's portfolio strategy positions fluticasone furoate as part of its respiratory franchise alongside biologics such as NUCALA (mepolizumab), enabling potential combination or sequential therapy approaches. The intranasal route of administration offers local delivery advantages with potentially reduced systemic exposure compared to oral alternatives, supporting differentiation in a competitive segment.
Drug intelligence
Fluticasone furoate is a small-molecule intranasal corticosteroid belonging to the respiratory system therapeutic class (ATC R03). The drug is formulated for nasal administration via spray delivery (ARNUITY ELLIPTA brand). Mechanism of action and specific molecular target are not yet disclosed in available regulatory documentation. Related therapies within the intranasal corticosteroid class include other fluticasone formulations and alternative corticosteroid agents. The drug represents a localized delivery approach to rhinitis management, contrasting with systemic corticosteroid or oral antihistamine alternatives.
- Modality: Small molecule
- Route: Intranasal spray
- Therapeutic Class: Respiratory system (R03)
- Brand Name: ARNUITY ELLIPTA
- Sponsor: GlaxoSmithKline
- Regulatory Status: Approved (US, EU, Australia)
rhinitis
Also known as: inflammation of nasal cavity mucosa, nasal cavity mucosa inflammation
Overview
An inflammation of the mucous membrane lining the nose, usually associated with nasal discharge.
Treatment landscape
ClinicalTrials.gov lists 102 registered studies for Rhinitis (AACT aggregate).
Phase breakdown: NA (48), PHASE3 (19), PHASE2 (15), PHASE4 (12), PHASE1 (5), PHASE2/PHASE3 (2), PHASE1/PHASE2 (1)
Common investigational therapies:
- Placebo
- SB-705498
- placebo
- Fluticasone
- Levocetirizine
- Loratadine
- Levocetirizine dihydrochloride
- Allerslit forte
- Desloratadine
- SCH 697243
Disease data sourced from MONDO Disease Ontology (MONDO:0003014), NCT00001224, NCT00001256, NCT00001351, NCT00001415, NCT00001541, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, NCT00078195, NCT00144443, NCT00200928, NCT00200954, NCT00279916, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 32017-01-09
Phase 3 completion
Most recent disclosed milestone for fluticasone furoate Phase 3 program.
- Approved2019-08-01
Australian approval
First PBS listing date for fluticasone furoate in Australia.
- Approved2025-06-25
EMA authorisation
European Medicines Agency authorisation date for fluticasone furoate formulation.
- Approved2026-05-07
EMA authorisation
Additional EMA authorisation date for fluticasone furoate product.
Competitive landscape
Fluticasone furoate operates within a competitive respiratory and rhinitis treatment landscape dominated by multiple approved therapies. Direct competitors include other intranasal corticosteroid formulations and combination products. Within the broader respiratory market, GlaxoSmithKline's own NUCALA (mepolizumab), an approved biologic for eosinophilic asthma and eosinophilic granulomatosis with polyangiitis, represents an alternative GSK respiratory asset. AstraZeneca's FASENRA PEN (benralizumab), an approved biologic targeting IL-5 receptor, competes in the severe asthma segment. Teva Pharma GmbH markets multiple approved respiratory products including CINQAERO, SEFFALAIR SPIROMAX, and AIREXAR SPIROMAX, indicating significant competitive presence in the respiratory space. Additional approved competitors include ANORO ELLIPTA, OHTUVAYRE, BRINSUPRI, BRETARIS GENUAIR, EXDENSUR, and RILTRAVA AEROSPHERE, representing diverse mechanisms and delivery platforms. Arcutis Biotherapeutics' DAXAS represents an alternative therapeutic approach. The competitive positioning of fluticasone furoate as an intranasal corticosteroid distinguishes it from systemic biologics and oral therapies, targeting the substantial patient population with allergic rhinitis requiring localized nasal treatment.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| CINQAERO | Teva Pharma GmbH | — | approved |
| DAXAS | Arcutis Biotherapeutics | — | approved |
| SEFFALAIR SPIROMAX | Teva Pharma GmbH | — | approved |
| AIREXAR SPIROMAX | Teva Pharma GmbH | — | approved |
| ANORO ELLIPTA (PREVIOUSLY ANORO) | — | — | approved |
| NUCALA | GlaxoSmithKline | — | approved |
| FASENRA PEN | AstraZeneca | — | approved |
| OHTUVAYRE | — | — | approved |
| BRINSUPRI | — | — | approved |
| BRETARIS GENUAIR | — | — | approved |
| EXDENSUR | — | — | approved |
| RILTRAVA AEROSPHERE | — | — | approved |
| TRIPROLIDINE HYDROCHLORIDE | — | Histamine H1 receptor antagonist | Approved |
| TRIAMCINOLONE ACETONIDE | — | Glucocorticoid receptor agonist | Approved |
| PYRILAMINE MALEATE | — | Histamine H1 receptor antagonist | Approved |
| PSEUDOEPHEDRINE SULFATE | — | Norepinephrine transporter releasing agent | Approved |
| PSEUDOEPHEDRINE HYDROCHLORIDE | — | Norepinephrine transporter releasing agent | Approved |
| PSEUDOEPHEDRINE | — | Norepinephrine transporter releasing agent | Approved |
| PROMETHAZINE HYDROCHLORIDE | — | Histamine H1 receptor antagonist | Approved |
| PREDNISONE | — | Glucocorticoid receptor agonist | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
United States: Fluticasone furoate holds FDA approval via multiple NDA applications: NDA022051, NDA204275, NDA205625, and NDA209482. Sponsors include GLAXO GRP LTD, GLAXOSMITHKLINE, and HALEON US HOLDINGS, indicating potential corporate restructuring or licensing arrangements.
European Union: The European Medicines Agency has granted marketing authorization for fluticasone furoate under seven product numbers (EMEA/H/C/000770, EMEA/H/C/001019, EMEA/H/C/002673, EMEA/H/C/002745, EMEA/H/C/004363, EMEA/H/C/004781, EMEA/H/C/005254). Marketing Authorization Holders include Glaxo Group Ltd. and GlaxoSmithKline Trading Services Limited. Authorisation dates span from June 25, 2025 to May 7, 2026, suggesting recent or pending approvals for specific formulations or indications.
Australia: Fluticasone furoate is approved and listed on the Pharmaceutical Benefits Scheme (PBS) with codes 11719T, 11729H, 14380W, and 14515Y. Sponsor is GlaxoSmithKline Australia Pty Ltd. First listing dates include August 1, 2019 and September 1, 2024, indicating potential product line extensions or reformulations.
- PMDA (Japan) status: Not yet disclosed
- NMPA (China) status: Not yet disclosed
- Expected loss of exclusivity date: Not yet disclosed
Clinical evidence summary
Key questions answered
What is fluticasone furoate used for?
Fluticasone furoate is an intranasal corticosteroid indicated for the treatment of rhinitis, including allergic rhinitis. It is administered as a nasal spray to reduce nasal inflammation and associated symptoms.
Is fluticasone furoate approved by the FDA?
Yes, fluticasone furoate holds FDA approval via multiple NDA applications (NDA022051, NDA204275, NDA205625, NDA209482). It is marketed under the brand name ARNUITY ELLIPTA in the United States.
What is the brand name for fluticasone furoate?
Fluticasone furoate is marketed as ARNUITY ELLIPTA, utilizing GSK's ELLIPTA dry powder inhaler platform adapted for intranasal delivery.
Who manufactures fluticasone furoate?
GlaxoSmithKline (GSK) is the primary sponsor and manufacturer. In the United States, HALEON US HOLDINGS is also listed as a sponsor, reflecting GSK's 2022 consumer healthcare separation.
How does fluticasone furoate work?
Fluticasone furoate is a corticosteroid that reduces nasal inflammation by suppressing immune-mediated inflammatory responses in the nasal mucosa. Specific molecular target and detailed mechanism of action are not yet disclosed.
What is the route of administration for fluticasone furoate?
Fluticasone furoate is administered as an intranasal spray, delivering the medication directly to the nasal cavity for localized therapeutic effect.
Is fluticasone furoate approved in Europe?
Yes, the European Medicines Agency has granted marketing authorization under seven product numbers (EMEA/H/C/000770, EMEA/H/C/001019, EMEA/H/C/002673, EMEA/H/C/002745, EMEA/H/C/004363, EMEA/H/C/004781, EMEA/H/C/005254) with authorisation dates from June 2025 to May 2026.
Is fluticasone furoate approved in Australia?
Yes, fluticasone furoate is approved and listed on the Australian Pharmaceutical Benefits Scheme (PBS) with codes 11719T, 11729H, 14380W, and 14515Y. First listing dates include August 1, 2019 and September 1, 2024.
What clinical trials support fluticasone furoate?
The program includes at least one Phase 3 trial (NCT01622231). Detailed trial results, design, and endpoints are not yet disclosed in available sources.
What is the current development status of fluticasone furoate?
Fluticasone furoate has completed Phase 3 clinical development (as of January 9, 2017) and has achieved regulatory approval in the US, EU, and Australia. The program is in the commercialization phase.
What are the main competitors to fluticasone furoate?
Competitors include other intranasal corticosteroids, as well as alternative respiratory therapies such as GlaxoSmithKline's NUCALA (mepolizumab), AstraZeneca's FASENRA PEN, and multiple products from Teva Pharma GmbH including CINQAERO, SEFFALAIR SPIROMAX, and AIREXAR SPIROMAX.
What therapeutic class does fluticasone furoate belong to?
Fluticasone furoate is classified within the respiratory system therapeutic class (ATC R03), specifically as an intranasal corticosteroid for rhinitis treatment.
Does fluticasone furoate have any partners or licensees?
No formal licensing partner is disclosed. However, HALEON US HOLDINGS is listed as a US sponsor, reflecting GSK's 2022 separation of consumer healthcare operations.
What is the modality of fluticasone furoate?
Fluticasone furoate is a small-molecule corticosteroid, representing a traditional pharmacological approach to rhinitis treatment rather than a biologic or novel modality.
When was fluticasone furoate first approved?
The earliest disclosed approval date is August 1, 2019 in Australia. US and EU approval dates are not yet disclosed, though multiple US NDA applications and recent EMA authorisations (2025-2026) are documented.
Is fluticasone furoate available over-the-counter?
Regulatory status regarding over-the-counter availability is not yet disclosed. PBS listing in Australia suggests prescription or restricted availability in that market.
Entity relationship graph
Fluticasone furoate → Drug → Target → Indication → Company → Trials → Competitors
Molecular targets
Companies
Indication
Trials
Competitors
- CINQAERO
- DAXAS
- SEFFALAIR SPIROMAX
- AIREXAR SPIROMAX
- ANORO ELLIPTA (PREVIOUSLY ANORO)
- NUCALA
- FASENRA PEN
- OHTUVAYRE
- BRINSUPRI
- BRETARIS GENUAIR
- EXDENSUR
- RILTRAVA AEROSPHERE
- TRIPROLIDINE HYDROCHLORIDE
- TRIAMCINOLONE ACETONIDE
- PYRILAMINE MALEATE
- PSEUDOEPHEDRINE SULFATE
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- PROMETHAZINE HYDROCHLORIDE
- PREDNISONE
Analyst insights
Strategic Positioning: GSK's fluticasone furoate approval across US, EU, and Australia establishes a commercial foundation within the rhinitis treatment segment. The intranasal corticosteroid mechanism aligns with first-line therapeutic guidelines for allergic rhinitis, supporting market penetration in a high-prevalence indication.
Competitive Implications: The crowded competitive landscape—including multiple approved intranasal corticosteroids and alternative delivery platforms—suggests fluticasone furoate competes on formulation, delivery device (ELLIPTA platform), and brand recognition rather than novel mechanism. GSK's portfolio integration with NUCALA enables potential sequential or combination therapy strategies in patients with overlapping asthma-rhinitis phenotypes.
Corporate Dynamics: The presence of HALEON US HOLDINGS as a sponsor in US regulatory filings reflects GSK's 2022 separation of its consumer healthcare business (now Haleon), indicating potential licensing or co-commercialization arrangements for certain markets or formulations.
Future Catalysts: Label expansions, additional geographic approvals (particularly in PMDA and NMPA jurisdictions), and potential combination formulations with antihistamines or other agents represent future development opportunities. PBS listing expansion in Australia and EMA authorisation dates through May 2026 suggest ongoing regulatory activity.
- Phase 3 completion (January 2017) represents final clinical development milestone
- Multiple regulatory approvals indicate successful commercialization trajectory
- Intranasal delivery platform differentiates from systemic alternatives
- GSK respiratory portfolio synergies support market access strategies
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is fluticasone furoate?
- Small-molecule intranasal corticosteroid for rhinitis treatment, marketed as ARNUITY ELLIPTA by GlaxoSmithKline.
- Is it FDA approved?
- Yes, via NDA022051, NDA204275, NDA205625, and NDA209482.
- Is it EMA approved?
- Yes, with seven product numbers and authorisation dates from June 2025 to May 2026.
- Is it approved in Australia?
- Yes, PBS listed with codes 11719T, 11729H, 14380W, 14515Y since August 2019.
- What is the indication?
- Rhinitis, including allergic rhinitis.
- How is it administered?
- Intranasal spray delivery.
- Who manufactures it?
- GlaxoSmithKline; HALEON US HOLDINGS in US market.
- What is the mechanism of action?
- Corticosteroid reducing nasal inflammation; specific target not yet disclosed.
- What is the drug modality?
- Small molecule.
- What is the therapeutic class?
- Respiratory system (ATC R03).
- What is the current development phase?
- Approved; Phase 3 completed January 2017.
- Does it have a development partner?
- No formal partner disclosed.
- What is the brand name?
- ARNUITY ELLIPTA.
- What is the internal code?
- 116365.
- What clinical trial supports it?
- NCT01622231; detailed results not yet disclosed.
- Who are the main competitors?
- Other intranasal corticosteroids; GSK NUCALA, AstraZeneca FASENRA PEN, Teva respiratory products.
- What is the expected loss of exclusivity?
- Not yet disclosed.
- What are the PBS codes in Australia?
- 11719T, 11729H, 14380W, 14515Y.
- What are the EMA product numbers?
- EMEA/H/C/000770, 001019, 002673, 002745, 004363, 004781, 005254.
- When was it first listed in Australia?
- August 1, 2019; September 1, 2024 for additional formulation.
- Is it approved in Japan?
- Status not yet disclosed.
- Is it approved in China?
- Status not yet disclosed.
- What is the patient population?
- Patients with allergic or non-allergic rhinitis requiring intranasal corticosteroid therapy.
- When did Phase 3 complete?
- January 9, 2017.
- What is the delivery device?
- ELLIPTA dry powder platform adapted for intranasal spray.
Evidence & sources
- ClinicalTrials.gov NCT01622231 (clinicaltrials)
- fluticasone furoate AU status (fda)
- fluticasone furoate EU status (ema)
- fluticasone furoate US status (fda)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0003014) (mondo)
- NCT00001224 (clinicaltrials_gov)
- NCT00001256 (clinicaltrials_gov)
- NCT00001351 (clinicaltrials_gov)
- NCT00001415 (clinicaltrials_gov)
- NCT00001541 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- NCT00078195 (clinicaltrials_gov)
- NCT00144443 (clinicaltrials_gov)
- NCT00200928 (clinicaltrials_gov)
- NCT00200954 (clinicaltrials_gov)
- NCT00279916 (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.