Isosorbide Dinitrate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Isosorbide Dinitrate: Predicted New Use in Alopecia
One-Sentence Summary
Isosorbide dinitrate is a nitric oxide (NO) donor and vasodilator, currently marketed in Australia as a sublingual tablet. The TxGNN model predicts it may be effective for alopecia, but no clinical trials and no publications were found for this prediction, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Alopecia |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L5 (model prediction only) |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Number of approvals | 1 licence record (single-ingredient product) |
| Recommended Decision | Hold |
The licence record compiled for this report has no approved indication text, so the original indication is not shown.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Isosorbide dinitrate is known as an NO donor and vasodilator. A hypothetical link to alopecia is improved scalp microcirculation, similar in concept to minoxidil, which is a vasodilator and potassium channel opener.
This link is speculative. No trials or literature support it, and a high TxGNN score is not clinical evidence. The model’s other hair-related predictions include hypertrichosis (excess hair growth, the opposite of alopecia) and hereditary hair disorders. This suggests the score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence or a drug-specific mechanism.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form |
|---|---|---|
| 13491C | Isordil Sublingual | Tablet 5 mg (sublingual) |
Only one licence record is listed. No approved indication text is recorded for it, and only the sublingual tablet route is available. A formulation suited to scalp use has not been identified.
Safety Considerations
No label-based warnings or contraindications are available in the compiled data. Please refer to the TGA-approved Product Information (PI) for safety information.
Contraindication relations in the knowledge graph (these come from the TxGNN knowledge graph, not from label text):
- Hypotensive disorder
- Hypertrophic cardiomyopathy
- Coronary artery disease
- Myocardial infarction
- Stroke and cerebrovascular disorders
- Intracerebral hemorrhage
- Intracranial hypertension and pseudotumor cerebri
- Anaemia and haemoglobinopathy
- Hyperthyroidism (including Graves disease and thyrotoxicosis)
Drug interactions: 100 interactions were recorded. The main Moderate-level interactions listed are:
- Bupropion
- Morphine and opium
- Dronabinol and nabilone
- SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin)
- Rosiglitazone
- Sapropterin
Omeprazole is recorded as a Minor interaction.
Conclusion and Next Steps
Decision: Hold
Rationale: The alopecia prediction has no supporting trials or publications, and its mechanistic basis is hypothetical. Systemic vasodilation also carries blood pressure risks that would need to be weighed against any hair benefit.
To proceed, the following is needed:
- Preclinical or early clinical evidence that NO donation affects hair growth in alopecia
- A scalp-appropriate formulation or route, since only a sublingual tablet is currently registered
- Safety data on hypotension risk in a non-cardiac population, and the TGA PI warnings and contraindications
- Mechanism of action data to support the proposed link
Other predictions in the same analysis have more supporting data and may be better candidates for follow-up. Pulmonary hypertension has a body of small haemodynamic studies, and vascular disease has one completed Phase 3 trial in diabetic foot ulcers (NCT02789033, n=68, results not available).
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.