Mometasone Furoate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Mometasone Furoate
- Mometasone Furoate: From Topical Corticosteroid Therapy to Sinonasal Polyp-Related Conditions
Mometasone Furoate: From Topical Corticosteroid Therapy to Sinonasal Polyp-Related Conditions
One-Sentence Summary
Mometasone furoate is a topical corticosteroid; however, this evidence pack shows the drug is not currently marketed in Taiwan or the EU, and both the original approved indication and mechanism of action (MOA) are missing from the source data. TxGNN screened 10 candidate new indications (all polyp/growth-related conditions), of which 8 have zero supporting evidence (pure AI prediction) and only 2 — polyp of frontal sinus and polyp of middle ear — are backed by clinical trials and literature, though one of these two appears to involve an ontology-mapping discrepancy that needs clarification before it can be treated as genuine repurposing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in available registrational data (no licenses on file; Mometasone furoate is a known topical corticosteroid class drug, but this specific approved indication is not confirmed in this evidence pack) |
| Predicted New Indications | 10 candidates evaluated; top TxGNN score: 2-hydroxyethyl methacrylate sensitization (98.62%); highest-evidence candidate: Polyp of frontal sinus (97.56%) |
| TxGNN Prediction Score Range | 97.51% – 98.62% |
| Evidence Level | L2 (2 of 10 candidates) / L5 (8 of 10 candidates) |
| EU Market Status | ✗ Not marketed |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (flagged as a High-severity data gap). Based on known pharmacological class information, mometasone furoate is a synthetic topical/intranasal glucocorticoid, generally understood to suppress Th2-driven inflammation (IL-4/IL-5/IL-13 axis), reduce eosinophilic infiltration, and decrease mucosal edema — mechanisms well established for allergic rhinitis and chronic rhinosinusitis with nasal polyps (CRSwNP).
Among the 10 TxGNN-predicted indications, 8 are structurally or pathologically unrelated to corticosteroid anti-inflammatory action (e.g., fibroepithelial polyp, neoplastic polyp, epulis, ureteral polyp) — these are largely mechanical, neoplastic, or reactive proliferative lesions rather than Th2-inflammation-driven conditions, and none have any clinical trial or literature support (L5, model prediction only).
The two candidates with actual evidence are both anatomical subtypes/variants connected to chronic rhinosinusitis with nasal polyps, a condition where mometasone’s mechanism is already well validated:
- Polyp of frontal sinus has genuine device-specific evidence: mometasone-eluting bioabsorbable implants (PROPEL/Sinuva-class devices) placed directly in the frontal sinus ostium, which is a real drug-device repurposing pathway rather than simple mechanistic extrapolation.
- Polyp of middle ear, however, shows a likely ontology mapping discrepancy — the linked trials and literature substantively describe standard sinonasal CRSwNP (an already-approved indication for mometasone nasal spray), not the middle ear. This candidate should be treated as an artifact requiring MONDO/disease-mapping review before being counted as a true “new” indication.
Clinical Trial Evidence
(Combining evidence linked to “Polyp of frontal sinus” and “Polyp of middle ear” — the two candidates with any trial data; other 8 candidates have no registered trials)
| Trial Number | Phase | Status | Enrollment | Indication (as mapped) | Key Findings |
|---|---|---|---|---|---|
| NCT03607175 | Phase 2/3 | Unknown | 30 | Frontal sinus polyp | Steroid-eluting implant vs. triamcinolone-CMC foam for post-FESS nasal polyposis care |
| NCT01616160 | Phase 4 | Terminated | 11 | Middle ear polyp (mapped)* | Steroid sensitivity of mometasone furoate nasal spray in nasal polyp tissue |
| NCT04915456 | Phase 4 | Completed | 106 | Middle ear polyp (mapped)* | Postoperative topical steroid spray ± systemic steroid in CRSwNP |
| NCT03280550 | Phase 3 | Completed | 138 | Middle ear polyp (mapped)* | Omalizumab (not mometasone) in CRSwNP — disease-relevant only |
| NCT02898454 | Phase 3 | Completed | 448 | Frontal sinus polyp | Dupilumab add-on to mometasone furoate nasal spray background therapy in bilateral nasal polyps |
| NCT02912468 | Phase 3 | Completed | 276 | Frontal sinus polyp | Dupilumab + mometasone background therapy, 24-week nasal polyposis study |
| NCT03401229 | Phase 3 | Completed | 413 | Frontal sinus polyp | Benralizumab (not mometasone) in severe nasal polyposis — disease-relevant only |
| NCT04851964 | Phase 3 | Completed | 416 | Frontal sinus polyp | Tezepelumab (not mometasone) in severe CRSwNP — disease-relevant only |
| NCT05545072 | Phase 3 | Terminated | 5 | Frontal sinus polyp | Dupilumab + intranasal corticosteroid post-ESS in allergic fungal rhinosinusitis |
| NCT04596189 | Phase 4 | Completed | 30 | Frontal sinus polyp | Dupilumab peri-operative use for CRSwNP recurrence prevention |
* Note: trials mapped to “polyp of middle ear” substantively describe nasal/sinus polyposis, not middle ear disease — likely an ontology mapping error (see rationale above).
The remaining 8 predicted indications (HEMA sensitization, vocal cord polyp, external auditory canal polyp, fibroepithelial polyp, vulvar polyp, ureteral polyp, epulis, neoplastic polyp) currently have no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29350840 | 2018 | RCT (Phase 3) | Int Forum Allergy Rhinol | Mometasone furoate sinus implant significantly improves outcomes in recurrent nasal polyposis after sinus surgery |
| 27302143 | 2016 | RCT | Am J Rhinol Allergy | Sodium hyaluronate added to topical corticosteroids improves CRSwNP outcomes |
| 33465455 | 2021 | RCT | Ann Allergy Asthma Immunol | Dupilumab improves airway control in CRSwNP with comorbid asthma (mometasone as background therapy) |
| 27141307 | 2016 | Review | Multidiscip Respir Med | Systematic review: intranasal mometasone furoate for rhinosinusitis, nasal polyposis, and middle-ear involvement of adenoidal hypertrophy |
| 30843454 | 2019 | Review | J Manag Care Spec Pharm | Budget impact of mometasone-eluting steroid implant vs. sinus surgery for CRSwNP |
| 19289710 | 2009 | Cohort | Arch Otolaryngol Head Neck Surg | Mometasone furoate prevents nasal polyp relapse after endoscopic sinus surgery |
| 31117809 | 2019 | Cohort | Am J Rhinol Allergy | Pooled analysis: in-office mometasone sinus implants for recurrent nasal polyps |
| 35362251 | 2022 | Cohort | Int Forum Allergy Rhinol | Intraoperative frontal sinus mometasone-eluting stents reduce IL-5/IL-13 in CRSwNP |
| 27758142 | 2016 | Cohort | Expert Opin Drug Deliv | PROPEL mometasone-eluting mini sinus implant for frontal sinus disease |
| 30431709 | 2019 | Cohort | Int Forum Allergy Rhinol | Pooled RCT analysis: bioabsorbable mometasone-releasing implants in frontal sinus ostia |
The remaining 8 predicted indications currently have no related literature available.
EU Market Information
This drug bundle shows 0 EU/Taiwan marketing authorizations on file — Mometasone furoate is not currently marketed under this evidence pack’s regulatory dataset, so no license table can be produced.
Safety Considerations
Please refer to the SmPC for safety information.
⚠️ Blocking data gap: TFDA label warnings/contraindications (DG001) could not be retrieved, which prevents completion of the S1 safety screening stage for any of the 10 candidates. No drug-drug interaction data is currently available (query status: not found).
Conclusion and Next Steps
Decision: Hold
Rationale: This drug is not marketed in Taiwan or the EU, its original indication and mechanism of action are undocumented in this evidence pack, and a Blocking-severity safety data gap (missing TFDA label) prevents even a preliminary safety screen (S1). Of the 10 TxGNN-predicted indications, 8 have no clinical or literature support at all (L5, decision stage S0), and the 2 with evidence (L2, S2, “Research Question”) require further verification — one due to a likely disease-ontology mapping error, and both because the identified evidence largely concerns a different, already-approved indication (CRSwNP) or a different drug (biologics used alongside mometasone as background therapy) rather than mometasone-specific efficacy in a genuinely new indication.
To proceed, the following is needed:
- Retrieve TFDA/EMA SmPC for warnings, contraindications, and DDI data (resolves DG001, currently Blocking)
- Retrieve confirmed MOA and original approved indication from DrugBank (resolves DG002)
- Clarify MONDO/ontology mapping for “polyp of middle ear” — current evidence suggests this may actually represent nasal polyposis (an existing indication), not a new indication
- If pursuing “polyp of frontal sinus,” evaluate feasibility of the implant/device-based delivery route (Propel/Sinuva-class), since mometasone-specific evidence here is device-mediated rather than via standard nasal spray or systemic administration
- Deprioritize (Hold) the remaining 8 candidates until independent clinical or preclinical evidence emerges
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.