Clascoterone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Clascoterone: From Acne Vulgaris to Candidiasis
One-Sentence Summary
Clascoterone is a topical androgen receptor antagonist, marketed in Singapore as a 1% cream and used for acne vulgaris. The TxGNN model predicts it may be effective for candidiasis, but no clinical trials and no publications currently support this direction. The prediction rests only on a graph-based model score.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence text (the approved indication is blank). Acne vulgaris, based on the drug's known clinical use |
| Predicted New Indication | Candidiasis |
| TxGNN Prediction Score | 94.82% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. From pharmacology data, clascoterone (cortexolone 17α-propionate) is a steroid that acts on the androgen receptor (AR). It is applied topically to reduce androgen signalling in sebaceous glands and hair follicles, which is how it treats acne. It is also being evaluated for androgenetic alopecia.
The link to candidiasis is weak. Clascoterone has no known antifungal activity, and no plausible connection between androgen receptor inhibition and Candida infection was identified. Local immunosuppressive or barrier effects have been suggested, but these are speculative. The high TxGNN score of 94.82% most likely reflects proximity in a knowledge graph, not biological or clinical rationale.
Other top predictions show the same pattern. They include oral candidiasis, several migraine entries, leprosy, atrophoderma vermiculata, adrenal gland hyperfunction and multiple endocrine neoplasia. All are at evidence level L5, with no trials or literature. The only weak steroid-pathway rationale applies to adrenal gland hyperfunction, and it is speculative.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN17072P | Winlevi Cream 1% w/w (Cosmo S.p.A.) | Cream (topical) | Indication text not recorded in the licence data |
Safety Considerations
- Drug Interactions: The only interaction record is a pharmacological one: clascoterone's target is the androgen receptor (AR). It is not a drug-drug interaction. No clinically graded interactions with other drugs were identified.
- Other: HPA axis suppression has been noted as a safety consideration for this steroid-derived topical drug, though systemic exposure is low.
Please refer to the package insert for warnings and contraindications, as these were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score (evidence level L5). There are no clinical trials or publications, no plausible antifungal mechanism, and the approved route (topical skin application) does not match the mucosal or systemic needs of many candidiasis presentations. There is not enough evidence to justify development.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA, since the safety review cannot proceed without them
- Detailed mechanism of action data (for example, from DrugBank)
- Preclinical evidence, such as in vitro antifungal activity against Candida species or an effect on host skin immunity
- A clear definition of the target population and route (for example, cutaneous candidiasis versus oral candidiasis)
- Confirmation of the approved acne indication in the Singapore licence record
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.