Mometasone
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Mometasone: From Nasal Corticosteroid Use to Primary Cutaneous T-Cell Lymphoma
One-Sentence Summary
Mometasone is a corticosteroid marketed in the US as metered nasal sprays. The supplied records do not state its approved indication. The TxGNN model predicts it may be effective for primary cutaneous T-cell lymphoma, but no clinical trials and only 2 case reports are on file, and neither shows mometasone working in this disease.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the records (all listed licenses have blank indication text) |
| Predicted New Indication | Primary cutaneous T-cell lymphoma |
| TxGNN Prediction Score | 99.36% |
| Evidence Level | L5 (model prediction only; the Evidence Pack assigned L4, but the two case reports do not support mometasone in this disease) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 14 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data for mometasone is not available in the supplied records. As a corticosteroid, mometasone plausibly acts through glucocorticoid receptor-mediated anti-inflammatory and pro-apoptotic effects on lymphocytes in the skin. This is general pharmacology, not something the records support directly.
Corticosteroids are widely used against inflammatory skin disease, and topical steroids are a standard treatment in early cutaneous T-cell lymphoma. The very high graph score most likely reflects this drug-class association rather than evidence specific to mometasone.
There is also a route gap. Every US product in the records is a metered nasal spray, and route compatibility with a skin-directed indication has not been assessed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40821495 | 2025 | Case Report | Proc (Bayl Univ Med Cent) | A 62-year-old woman had cutaneous pseudolymphoma, a benign condition that mimics lymphoma. Mometasone and tacrolimus failed, and she was then treated with tapinarof. It does not show mometasone benefit in true lymphoma. |
| 25442255 | 2015 | Case Report | J Cutan Pathol | An 11-year-old boy had CD8+CD56+ cytotoxic-type mycosis fungoides, a form of cutaneous T-cell lymphoma, with delayed diagnosis. The available abstract excerpt does not mention mometasone. |
US Market Information
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| NDA215712 | Nasonex (L. Perrigo Company) | Spray, metered |
| NDA215712 | Rugby mometasone furoate nasal (Rugby Laboratories) | Spray, metered |
| ANDA217498 | Mometasone Furoate (Aurohealth LLC) | Spray, metered |
| NDA215712 | up and up allergy (Target Corporation) | Spray, metered |
| NDA215712 | allergy nasal (Walgreen Company) | Spray, metered |
The records give no approved indication text for these licenses.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score is not backed by any trial, and the only literature is two case reports. One describes a mometasone failure in a benign look-alike condition, and the other does not mention mometasone. The marketed forms are nasal sprays, which do not match a skin-directed indication.
To proceed, the following is needed:
- Package insert warnings and contraindications, which are currently missing and block safety screening
- Mechanism of action data for mometasone (e.g., from DrugBank)
- Published evidence of topical mometasone in mycosis fungoides or other cutaneous T-cell lymphoma, such as retrospective series or trials
- Route and formulation assessment: whether a topical mometasone product exists and how it fits this indication
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.