Nicorandil
| Evidence Level: L4 | Predicted Indications: 6 |
Table of Contents
Nicorandil: From Angina Pectoris to Benign Prostatic Hyperplasia
One-Sentence Summary
Nicorandil is a potassium channel opener with nitrate-like activity, used in several countries to treat chronic stable angina pectoris. The TxGNN model predicts it may be effective for benign prostatic hyperplasia (BPH), but there are currently no registered clinical trials and only 3 publications (two reviews and one animal study) supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Chronic stable angina pectoris (based on pharmacology reference data; the ARTG entry in the data compiled for this report has no indication text) |
| Predicted New Indication | Benign prostatic hyperplasia |
| TxGNN Prediction Score | 0.9971 |
| Evidence Level | L4 |
| 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) |
| Recommended Decision | Hold (research question stage) |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, nicorandil is a K-ATP channel opener with nitrate-like activity that causes vasodilation. Pharmacology data list Kir6.1 and Kir6.2 as its targets. Its efficacy in angina is attributed to improved vascular blood flow.
The proposed link to BPH is vascular. Several publications suggest that impaired blood supply and ischaemia of the prostate and lower urinary tract contribute to BPH and lower urinary tract symptoms (LUTS). Clinical data have shown an association between BPH and atherosclerotic disease such as hypertension. A vasodilator that improves prostatic perfusion is therefore a plausible approach.
The supporting data are preclinical or hypothesis-driven. In a spontaneously hypertensive rat model, prostatic ischaemia induced ventral prostatic hyperplasia, and the rats were treated with nicorandil for six weeks. Human efficacy cannot be confirmed from the data compiled here.
Other predicted indications (alopecia, hypotrichosis, osteoarthritis and rare skeletal dysplasias) have no trials or literature. They are model predictions only and are not assessed further.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31735753 | 2019 | Review | Nihon Yakurigaku Zasshi | Reviews evidence that impaired prostatic blood supply contributes to BPH/BPE and LUTS, and links BPH with atherosclerotic disease |
| 24448152 | 2014 | Preclinical animal study | Scientific Reports | In spontaneously hypertensive rats, prostatic ischaemia induced ventral prostatic hyperplasia; rats were treated with nicorandil for six weeks, with blood pressure and prostatic blood flow measured |
| 26165338 | 2015 | Review | Nihon Yakurigaku Zasshi | Discusses LUTS as a vascular dysfunction and the effect of nicorandil as a vasodilator (no abstract available) |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 13550E | Ikotab | Tablets 10 mg, 60 (oral) | Not available in the data compiled for this report |
Safety Considerations
Please refer to the TGA-approved Product Information (PI) for safety information.
The pharmacology data identify Kir6.1 and Kir6.2 as nicorandil targets. These are not drug-drug interactions, and no specific interacting drugs were identified in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence is limited to a plausible vascular mechanism, one animal study and two review articles. There are no registered human trials. The evidence level is L4, so the prediction is best treated as a research question rather than a candidate for clinical use.
To proceed, the following is needed:
- Human clinical data (observational or controlled studies) on nicorandil in BPH or LUTS
- Mechanism of action data to strengthen the mechanistic link analysis
- Safety information from the TGA-approved Product Information, including warnings and contraindications, which is needed before any safety screening
- Confirmation of the approved indication text for the Australian ARTG entry
- Assessment of safety in older men, who are the main BPH population and are often on antihypertensive or nitrate therapy
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.