Silodosin
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Silodosin
- Silodosin: From Benign Prostatic Hyperplasia to Ambras Type Hypertrichosis Universalis Congenita
Silodosin: From Benign Prostatic Hyperplasia to Ambras Type Hypertrichosis Universalis Congenita
One-Sentence Summary
Silodosin is a drug originally used to treat benign prostatic hyperplasia (BPH). The TxGNN model predicts it may be effective for Ambras type hypertrichosis universalis congenita, but there are currently 0 clinical trials and 0 publications supporting this direction, so the prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Benign prostatic hyperplasia |
| Predicted New Indication | Ambras type hypertrichosis universalis congenita |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (all licenses cancelled) |
| Number of NDAs | 9 (all ANDAs) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on its known pharmacology, silodosin is a selective alpha-1A adrenergic receptor antagonist. It relaxes smooth muscle in the prostate and bladder neck, which is how it relieves urinary symptoms of BPH.
The link to the predicted indication is weak. Ambras syndrome is a rare congenital disorder associated with genomic rearrangements affecting regulation of the TRPS1 gene. This pathway is unrelated to alpha-1A adrenergic signaling. The very high TxGNN score (99.99%) reflects proximity in the knowledge graph, not pharmacological or clinical evidence.
Other predictions for this drug follow the same pattern, and none has a credible mechanism:
| Rank | Predicted Indication | TxGNN Score | Assessment |
|---|---|---|---|
| 2 | Hypertrichosis | 99.99% | Alpha-1A blockade is not known to stimulate hair growth. This likely reflects graph proximity to the rare congenital hypertrichosis entries. Hypertrichosis would be an adverse effect rather than a therapeutic goal. |
| 3 | Malformation syndrome with odontal and/or periodontal component | 99.99% | Congenital structural defects are not expected to respond to an alpha-1A antagonist. |
| 4 | Syndrome with a Dandy-Walker malformation as major feature | 99.98% | A congenital brain malformation is not expected to be reversed by silodosin. |
| 5 | Isolated genetic hair shaft abnormality | 99.98% | The cause is structural gene defects, with no known role for alpha-1A antagonism. |
| 6 | Familial isolated trichomegaly | 99.23% | A rare, mostly benign trait with no link to alpha-1A antagonists. |
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
All nine US authorizations are generic (ANDA) silodosin oral capsules and all are listed as cancelled. The approved indication text is not available in the data compiled for this report.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA209745 | Silodosin | Capsule | AvKARE |
| ANDA211731 | Silodosin | Capsule | Alembic Pharmaceuticals Limited |
| ANDA210626 | Silodosin | Capsule | Aurobindo Pharma Limited |
| ANDA213230 | Silodosin | Capsule | Creekwood Pharmaceuticals LLC |
| ANDA211166 | Silodosin | Capsule | Macleods Pharmaceuticals Limited |
Four more cancelled ANDAs are also on record: Ajanta, Lupin, Camber and PD-Rx.
Safety Considerations
Contraindication-related conditions (from knowledge graph associations, not label text):
- Multiple system atrophy
- Postural orthostatic tachycardia syndrome
- Orthostatic hypotension
- Liver failure
- Kidney disease
- Pyoureter
- Intraoperative floppy iris syndrome
Drug Interactions: 99 interactions were identified. Examples:
- Major: Clarithromycin
- Moderate: Cimetidine, Bupropion, Aprepitant, Morphine, Dexamethasone, Miconazole, Clotrimazole, Rolapitant, Opium, and the SGLT2 inhibitors canagliflozin, dapagliflozin, empagliflozin and ertugliflozin
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no clinical trial or literature support (Evidence Level L5) and no plausible mechanistic link between alpha-1A adrenergic antagonism and a congenital hair disorder. All US licenses are also cancelled, so there is no marketed product to build on.
To proceed, the following is needed:
- Complete mechanism of action data
- FDA package insert warnings and contraindications, needed for safety screening
- Preclinical or mechanistic evidence linking alpha-1A antagonism to hair follicle biology or TRPS1 pathways
- Clarification of whether the hypertrichosis signal reflects an adverse effect rather than a therapeutic opportunity
- Confirmation of the regulatory pathway, given that all US licenses are cancelled
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.