Mesterolone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Mesterolone: From Androgen Deficiency Therapy to Gout
One-Sentence Summary
Mesterolone is an oral androgen (a derivative of dihydrotestosterone) that is registered in Singapore, but the registration record does not state an approved indication. The TxGNN model predicts it may be effective for gout, but no clinical trials and no relevant publications currently support this direction. The prediction rests on the knowledge-graph model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore registration record |
| Predicted New Indication | Gout |
| TxGNN Prediction Score | 98.20% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, mesterolone is an oral androgen derived from dihydrotestosterone. Its original use is not documented in the data compiled for this report, so its link to gout cannot be assessed directly.
A connection between sex hormones and uric acid handling is conceivable, but this is speculation. The data compiled for this report contains no mechanistic or clinical support. The high score (0.982) is a knowledge-graph prediction only and should not be read as evidence of efficacy.
Other predicted indications were also reviewed (type 1 diabetes, allergic and intrinsic asthma, diabetic nephropathy, autoimmune oophoritis, heart disease and several rare genetic syndromes). None has clinical trial support. The only linked literature is a preclinical study suggesting possible harm to the heart (see Safety Considerations).
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for gout.
For context, the literature linked to other predicted indications is of little help:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15025811 | 2004 | Review | Ann Clin Biochem | Case on diagnosing pituitary apoplexy in a patient with type 1 diabetes. Does not address mesterolone, so it is irrelevant. |
| 18808528 | 2008 | Preclinical (mouse) | Int J Exp Pathol | Mesterolone had adverse effects on cardiac remodelling and lipoprotein profile; aerobic exercise attenuated them. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN10249P | RESTORE TABLET 25 mg | Tablet | Not stated in the registration record |
Safety Considerations
- Cardiovascular signal: A mouse study (PMID 18808528) reported adverse effects of mesterolone on cardiac remodelling and lipoprotein profile. This is preclinical and indirect, but it is a caution for any long-term repurposing use.
Please refer to the package insert for other safety information, including warnings, contraindications and drug interactions.
Conclusion and Next Steps
Decision: Hold
Rationale: The gout prediction is supported only by a model score, with no clinical trials, no relevant literature and no documented mechanism. The only drug-specific literature found points to a possible cardiac safety concern rather than a benefit.
To proceed, the following is needed:
- The package insert (warnings, contraindications) from the Health Sciences Authority (HSA), as safety screening cannot proceed without it
- Mechanism of action data for mesterolone
- The approved indication for the Singapore registration
- A literature search specific to mesterolone and gout or urate metabolism
- A review of the cardiovascular and metabolic safety signal before any further evaluation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.