Spironolactone
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
- Spironolactone
- Spironolactone: From Marketed Mineralocorticoid Receptor Antagonist to Hypotrichosis Simplex of the Scalp
Spironolactone: From Marketed Mineralocorticoid Receptor Antagonist to Hypotrichosis Simplex of the Scalp
One-Sentence Summary
Spironolactone is a marketed oral tablet in South Africa, generally known as a mineralocorticoid receptor antagonist with anti-androgen activity. The TxGNN model predicts it may be useful for hypotrichosis simplex of the scalp (a second prediction is congenital hypotrichosis milia). Support is the model prediction alone: 0 clinical trials and 0 publications were found.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Hypotrichosis simplex of the scalp |
| TxGNN Prediction Score | 99.26% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 2 |
| Recommended Decision | Hold |
Second prediction: congenital hypotrichosis milia (score 99.04%, L5, Hold).
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Spironolactone is generally known as a mineralocorticoid receptor antagonist with anti-androgen activity. It is used off-label in androgen-related hair loss, so a link to hair disorders is conceivable.
However, hypotrichosis simplex of the scalp is a rare, largely hereditary hair-growth disorder, and an anti-androgen mechanism is not clearly relevant. The same applies to congenital hypotrichosis milia, a rare congenital condition. The prediction may reflect shared hypotrichosis-related neighbours in the knowledge graph rather than a plausible biological pathway.
A high graph score reflects network proximity. It is not evidence of efficacy or safety, and the link should be treated as speculative until reviewed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| Reg. No. Q/18.1/70 | Spironolactone 25 kiara (was sandoz spir | Tablet |
| Reg. No. H1945 (Act 101 of 1965) | Aldazide | Tablet |
Both products are oral tablets. No approved indication text was available in the registration records.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is a knowledge-graph score, with no trials, no literature, and no confirmed mechanism. The biological link to a rare hereditary hair disorder is unclear.
To proceed, the following is needed:
- A systematic literature search for spironolactone in hypotrichosis and related hereditary hair disorders
- Mechanism of action data and a mechanistic review of the link to both predicted conditions
- The SAHPRA package insert (warnings and contraindications), which is required before any safety screening
- Confirmation of the approved indications for the two registered products
- Assessment of route compatibility (scalp or hair disorders may need a topical rather than oral route)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.