Isosorbide Dinitrate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Isosorbide Dinitrate: From Angina Pectoris to Alopecia
One-Sentence Summary
Isosorbide dinitrate is an organic nitrate vasodilator, and the label text in the data supplied is blank, so its usual use in angina comes from general pharmacology knowledge. The TxGNN model predicts it may be effective for alopecia, but 0 clinical trials and 0 publications support this direction. It is a model-only signal.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Angina pectoris (general pharmacology knowledge; the supplied US label text is empty) |
| Predicted New Indication | Alopecia |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the Evidence Pack. Isosorbide dinitrate is a nitric oxide (NO) donor and organic nitrate. Nitrates of this type cause cGMP-mediated vasodilation.
The only proposed link to alopecia is speculative. NO-mediated vasodilation could raise blood flow around hair follicles, as some other vasodilators are thought to do. No trial or publication tests this idea.
The other hair-related predictions in the same list (congenital hypotrichosis milia, hypotrichosis simplex of the scalp, diffuse alopecia areata, hypertrichosis) also have no evidence. Alopecia areata is autoimmune, and a nitrate has no established immunomodulatory rationale there. The high scores probably reflect proximity to other hair phenotypes in the knowledge graph, not a real pharmacological signal.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
The Evidence Pack lists 20 authorizations. The five below are the main ones shown. All are oral tablets, and the approved indication text is empty for every one.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA088088 | Isosorbide Dinitrate | Tablet | Golden State Medical Supply, Inc. |
| ANDA086923 | Isosorbide Dinitrate | Tablet | Endo USA, Inc. |
| ANDA088088 | Isosorbide Dinitrate | Tablet | Major Pharmaceuticals |
| ANDA086067 | Isosorbide | Tablet | BluePoint Laboratories |
| ANDA213057 | Isosorbide dinitrate | Tablet | Zydus Pharmaceuticals (USA) Inc. |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found for this drug in the queried source.
Conclusion and Next Steps
Decision: Hold
Rationale: The alopecia prediction rests only on a high model score, with no trials, no literature, and only a speculative mechanism. This is L5 evidence and does not justify further investment.
To proceed, the following is needed:
- Any preclinical or clinical evidence linking nitrates or NO donors to hair growth or follicle blood flow
- Detailed mechanism of action data and package insert warnings and contraindications
- Consideration of route compatibility, since only oral tablets are marketed in the US and topical delivery would be a different product
Note: Other predictions in the same Evidence Pack have more support. Pulmonary hypertension is L3, with small hemodynamic studies, and vascular disease is L2, though the Phase 2 RCT tested isosorbide mononitrate rather than isosorbide dinitrate. Both are better candidates for a follow-up evaluation.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.