Finasteride
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Finasteride
- Finasteride: From Androgen-Related Conditions to Ambras Type Hypertrichosis Universalis Congenita
Finasteride: From Androgen-Related Conditions to Ambras Type Hypertrichosis Universalis Congenita
One-Sentence Summary
Finasteride is an oral 5-alpha reductase inhibitor that lowers DHT. The record supplied no approved indication text, so the original use is not confirmed here. The TxGNN model predicts it may be effective for Ambras type hypertrichosis universalis congenita, with a very high score. However, there are 0 clinical trials and 0 publications for this indication, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (approved indication text is empty in all listed licenses) |
| Predicted New Indication | Ambras type hypertrichosis universalis congenita |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 licenses (NDA and ANDA combined) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Finasteride inhibits type II 5-alpha reductase and lowers DHT, which acts on androgen-dependent hair follicles. Detailed mechanism-of-action data is not available in the record, so this description is the only mechanistic basis.
The link to the predicted disease is weak. Ambras syndrome is a congenital, androgen-independent hypertrichosis. It is usually attributed to chromosomal rearrangements that dysregulate TRPS1 and related hair-follicle genes. No DHT-dependent mechanism is established.
The high score most likely reflects knowledge-graph proximity to other hair-related disorders rather than a true mechanistic match. The prediction should be treated as a hypothesis, not as supported repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA078341 | Finasteride | Film-coated tablet | Aurobindo Pharma Limited |
| NDA020788 | PROPECIA | Film-coated tablet | Organon LLC |
| ANDA204304 | Finasteride | Film-coated tablet | Proficient Rx LP |
| ANDA090121 | Finasteride | Film-coated tablet | Proficient Rx LP |
| ANDA090060 | Finasteride | Film-coated tablet | NuCare Pharmaceuticals, Inc. |
All listed products are oral tablets. Approved indication text was empty in the source data.
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found in the record.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no trials or literature behind it, and Ambras syndrome is androgen-independent, so DHT suppression is not expected to help. The score is model-derived only.
To proceed, the following is needed:
- Package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism-of-action data from DrugBank
- Original approved indication text
- Any preclinical or case-level evidence linking 5-alpha reductase inhibition to TRPS1-related or congenital hypertrichosis phenotypes
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.