Fluticasone Furoate
| Evidence Level: L4 | Predicted Indications: 8 |
Table of Contents
Fluticasone Furoate: From Its Marketed Use to Atopic Eczema
One-Sentence Summary
Fluticasone furoate is a corticosteroid marketed in the US as an inhaled powder and a nasal spray. The original approved indication is not recorded in the source data. The TxGNN model predicts it may be effective for atopic eczema, with 12 clinical trials and 2 publications retrieved. Almost all of the trials test fluticasone propionate (a different salt), so the support is indirect and class-level.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 18 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, fluticasone furoate is a high-potency glucocorticoid receptor agonist. Glucocorticoids reduce Th2 cytokines and limit eosinophil and T-cell infiltration in tissue. This is the same inflammatory pathway that drives atopic eczema, so the class-level rationale is plausible.
Topical corticosteroids are already standard care for atopic eczema. The trials retrieved show this: fluticasone propionate cream is used as the active treatment or comparator in several atopic dermatitis studies. However, these trials do not test the furoate salt. The TxGNN score is a model prediction, not clinical evidence.
There is also a route issue. The marketed furoate products in the data are an inhaled powder (Ellipta) and a nasal spray. No dermatologic (topical) furoate product appears, so the route needed for atopic eczema is not confirmed as compatible.
Clinical Trial Evidence
Twelve trials were retrieved. The table lists the 8 most relevant. Four were excluded as off-target: NCT00426283 (eosinophilic esophagitis), NCT03594565 (glucose-monitor adhesive skin reactions), NCT04706559 (probiotics), and one duplicate-purpose entry.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01772056 | Phase 3 | Terminated | 54 | Double-blind RCT of twice-weekly fluticasone propionate 0.05% cream to prevent relapse in children with mild-to-moderate atopic dermatitis. Propionate salt, terminated early. |
| NCT01915914 | Phase 4 | Completed | 107 | Open-label randomized study of intermittent fluticasone propionate 0.05% cream plus moisturizer to reduce relapse in children. |
| NCT00546000 | Phase 4 | Completed | 56 | Open-label, single-arm study of Cutivate (propionate) lotion 0.05% and its effect on the HPA axis in infants with atopic dermatitis. Safety-oriented. |
| NCT07537751 | N/A | Completed | 40 | Double-blind comparison of crisaborole 2% vs fluticasone propionate 0.05% in children with mild-to-moderate atopic dermatitis. Fluticasone is the comparator. |
| NCT00616538 | Phase 4 | Completed | 121 | Pilot of Epiceram (ceramide emulsion) vs a mid-strength topical steroid in pediatric atopic dermatitis. Fluticasone is only a possible comparator. |
| NCT00689832 | Phase 4 | Completed | 487 | Tacrolimus 0.03% vs fluticasone 0.005% ointment in children with moderate-to-severe atopic dermatitis. |
| NCT00690105 | Phase 4 | Completed | 577 | Tacrolimus 0.1% vs fluticasone 0.005% ointment in adults with facial atopic dermatitis. |
| NCT00119158 | Phase 4 | Completed | 90 | Vehicle-controlled paired study of Elidel 1% plus Cutivate 0.05% cream in severe atopic dermatitis. |
Note: None of these trials tests fluticasone furoate in atopic eczema.
Literature Evidence
Only 2 publications were retrieved, and neither tests fluticasone furoate in atopic eczema.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 19571596 | 2009 | Review | Neuroimmunomodulation | Reviews HPA-axis (adrenal) suppression from intranasal corticosteroids in allergic rhinitis, which often coexists with asthma and atopic dermatitis. Relevant to safety, not efficacy. |
| 40066386 | 2025 | Case report | Indian Journal of Otolaryngology and Head and Neck Surgery | Allergen immunotherapy in a patient with autoimmune disease. Atopic dermatitis is mentioned only in passing. Little relevance. |
US Market Information
The 5 source rows contain two exact duplicates. The table shows the 4 distinct authorizations. The source did not record approved-indication text for any of them.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA205625 | Fluticasone Furoate Ellipta | Powder | Prasco Laboratories |
| NDA205625 | Arnuity Ellipta | Powder | GlaxoSmithKline LLC |
| NDA022051 | FLONASE SENSIMIST | Metered spray | A-S Medication Solutions |
| BLA101833 | Oat Food | Solution | Greer Laboratories, Inc. |
Note: BLA101833 is an allergenic product, probably a mapping artifact. It should be checked before it is counted as a fluticasone furoate license.
Safety Considerations
Please refer to the package insert for safety information. The source data has no warnings or contraindications, and the drug-interaction query returned no results.
Related literature (a review of intranasal corticosteroids) and a pediatric HPA-axis trial of topical fluticasone propionate (NCT00546000) both point to systemic corticosteroid effects as a safety area worth checking, especially in children.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanistic rationale is plausible, but the evidence is class-level and indirect. The trials test the propionate salt, not the furoate, and no furoate-specific data exist for atopic eczema. The marketed furoate products are inhaled or nasal, not topical, and the package insert safety data has not been obtained.
To proceed, the following is needed:
- Package insert warnings and contraindications (blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Confirmation of whether a topical fluticasone furoate formulation exists or is feasible
- Furoate-specific efficacy and safety data in atopic dermatitis, including HPA-axis and pediatric safety
- Confirmation of the original approved indication, to check overlap with existing labels
- Merge the duplicate “atopic eczema” and “dermatitis, atopic” predictions (rank 1 and rank 4 share identical evidence) to avoid double counting
Other predictions in the pack:
- Bronchitis (L3): the data are mostly COPD and asthma studies, and this overlaps existing marketed use, so it is not a clear repurposing case.
- Contact dermatitis (L4): no fluticasone furoate trials or literature were found.
- 2-hydroxyethyl methacrylate sensitization, occupational dermatitis and phototoxic dermatitis (L5): model prediction only, with no trials or literature.
- Asthma-related traits, susceptibility to (L5): a genetic trait, not a treatable indication.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.