Nicorandil
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Nicorandil: From Angina Pectoris to Benign Prostatic Hyperplasia
One-Sentence Summary
Nicorandil is a potassium-channel activator and nitric oxide donor conventionally used in the management of angina pectoris. The TxGNN model predicts it may also be effective for Benign Prostatic Hyperplasia (BPH), but this direction is currently supported only by 0 clinical trials and 3 mechanistic/preclinical publications, with no human interventional data.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Angina pectoris (based on known pharmacological classification as a KATP-channel opener/NO donor — not verified against UK licensing data in this evidence pack) |
| Predicted New Indication | Benign Prostatic Hyperplasia |
| TxGNN Prediction Score | 99.71% |
| Evidence Level | L4 (preclinical/mechanistic studies only) |
| UK Market Status | Not marketed (per this evidence pack) |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed, sourced mechanism-of-action data is not available in this evidence pack (flagged as a High-severity data gap). Based on the mechanistic rationale accompanying the top prediction, nicorandil acts as a KATP-channel opener and nitric oxide donor with vasodilator properties — the same pharmacology underlying its established anti-anginal effect on coronary blood flow.
The proposed link to BPH rests on the “vascular ischaemia hypothesis” of lower urinary tract symptoms (LUTS), which suggests that chronic impairment of prostatic blood flow contributes to stromal hyperplasia. Under this hypothesis, a drug that dilates prostatic vasculature could theoretically improve local perfusion and reduce hyperplastic stimulus, mirroring how nicorandil improves myocardial perfusion in angina.
However, this remains a theoretical extrapolation. The supporting literature consists of two narrative reviews discussing the vascular hypothesis of BPH/LUTS and one preclinical study in a spontaneously hypertensive rat model, with no human trials evaluating nicorandil for BPH. The biological plausibility is reasonable but unproven in patients.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31735753 | 2019 | Review | Nihon Yakurigaku Zasshi (Folia Pharmacologica Japonica) | Discusses prostatic blood flow as a therapeutic target in BPH/BPE, citing clinical associations between BPH/BPE and atherosclerotic disease |
| 26165338 | 2015 | Review | Nihon Yakurigaku Zasshi (Folia Pharmacologica Japonica) | Frames LUTS as a vascular dysfunction and discusses nicorandil’s vasodilator effect as a potential mechanism (abstract not available) |
| 24448152 | 2014 | Preclinical (animal, SHR model) | Scientific Reports | In spontaneously hypertensive rats, nicorandil treatment was used to investigate the link between prostatic blood flow and prostatic hyperplasia development |
UK Market Information
Nicorandil is recorded as not marketed in the UK in this evidence pack, with 0 marketing authorisations currently identified. No product-level licensing detail is available to summarise here.
Safety Considerations
Please refer to the SmPC and BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Note: No drug interaction (DDI) data, warnings, or contraindications were retrievable in this evidence pack (query returned no results). This is flagged as a Blocking data gap (DG001), meaning an initial safety assessment (Stage S1) cannot currently be completed.
Conclusion and Next Steps
Decision: Hold
Rationale: The BPH prediction is supported only by mechanistic reasoning and one preclinical animal study, with no clinical trials in humans and no UK marketing authorisation on record. A confirmed safety data gap also blocks a preliminary safety assessment, so the candidate cannot yet advance beyond a research hypothesis.
To proceed, the following is needed:
- SmPC/product warnings and contraindications data (DG001, Blocking) — required before any safety screening can proceed
- Verified mechanism-of-action documentation (DG002, High) to substantiate the vascular-ischaemia rationale
- Confirmed original indication and UK licensing status for nicorandil (not present in this evidence pack)
- Human proof-of-concept or pilot clinical data specifically evaluating nicorandil in BPH/LUTS before any further prioritisation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.