Nicorandil

Evidence Level: L4

Predicted Indications: 6

Nicorandil

Pharmacist Assessment Report

Nicorandil: From Angina Pectoris to benign prostatic hyperplasia (disease)

One-Sentence Summary

Nicorandil is a potassium-channel opener with a nitrate-like component, used to treat chronic stable angina pectoris in countries where it is approved. The TxGNN model predicts it may be effective for benign prostatic hyperplasia (BPH), but this rests on 0 registered clinical trials and 3 publications (one preclinical animal study and two Japanese-language reviews). The prediction is best treated as a research question rather than an actionable repurposing candidate.

Quick Overview

Item	Content
Original Indication	Chronic stable angina pectoris (from the pharmacology reference data; the Indian licence records contain no indication text)
Predicted New Indication	Benign prostatic hyperplasia
TxGNN Prediction Score	0.9971
Evidence Level	L4
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the compiled data. Based on known information, nicorandil is a K-ATP channel opener with a nitrate-like nitric oxide (NO) donor component, which produces vasodilation. The pharmacology data list its targets as the Kir6.1 and Kir6.2 channel subunits.

The proposed link to BPH runs through blood flow. The literature suggests that reduced prostatic blood flow (ischaemia) may contribute to the development of BPH and lower urinary tract symptoms (LUTS). Clinical data show an association between BPH and atherosclerotic disease such as hypertension. A vasodilator that improves microcirculation could therefore plausibly relieve these problems.

This remains a hypothesis. The supporting data come from an animal model (ventral prostatic hyperplasia in spontaneously hypertensive rats) and narrative reviews. No registered trials were found, and the titles and abstracts do not confirm direct clinical efficacy of nicorandil in BPH patients.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
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, and blood pressure, prostatic blood flow and tissue oxidative-stress markers were measured.
31735753	2019	Review	Nihon Yakurigaku Zasshi	Reviews evidence that impaired blood supply to the lower urinary tract contributes to BPH and LUTS, and discusses prostatic blood flow as a therapeutic target.
26165338	2015	Review	Nihon Yakurigaku Zasshi	Discusses LUTS as a vascular dysfunction and the effect of nicorandil as a vasodilator (no abstract available).

India Market Information

Twenty single-ingredient oral tablet licences are currently valid, and none have been cancelled. The records contain no approved indication text. The main authorisations are:

Authorization Number	Product Name	Dosage Form	Approved Indication
115647	Korandil 5 Tablet (Sun Pharmaceutical Industries Ltd)	Strip of 10 tablets	Not stated in the records
247631	Zynicor 10mg Tablet (Zydus Cadila)	Strip of 30 tablets	Not stated in the records
247169	Zynicor 5 Tablet (Zydus Cadila)	Bottle of 30 tablets	Not stated in the records
150503	Nicoduce 5 Tablet (Abbott)	Bottle of 20 tablets	Not stated in the records
38755	Corflo 5mg Tablet (Wockhardt Ltd)	Strip of 20 tablets	Not stated in the records

Safety Considerations

Please refer to the package insert for safety information.

The interaction data compiled for this report list only pharmacological targets (Kir6.1 and Kir6.2 potassium channel subunits), not drug-drug interactions with specific agents. Because nicorandil has a vasodilating, nitrate-like action, the package insert should be checked for interactions with other vasodilators and blood-pressure-lowering drugs before any use in a new population such as older men with BPH.

Conclusion and Next Steps

Decision: Hold

Rationale: The BPH prediction has a high model score but only preclinical and review-level support, with no registered clinical trials. The mechanistic link (improved prostatic blood flow) is plausible but unproven in humans, so this is a research question and not yet a candidate for development.

To proceed, the following is needed:

Package insert warnings and contraindications from the Indian regulator, which are currently missing and block safety screening
Detailed mechanism of action data (for example, from DrugBank)
Human data on prostatic blood flow or LUTS outcomes with nicorandil, such as a small exploratory trial
A safety assessment for men with BPH, especially regarding hypotension and use alongside alpha-blockers or PDE5 inhibitors
Review of the full text of the three publications to confirm what they show about nicorandil specifically

Other Predicted Indications (Lower Priority)

Nine further predictions have no clinical trials or literature in the compiled data (evidence level L5, recommendation: Hold). They are listed for completeness only.

Predicted Indication	TxGNN Score	Comment
Alopecia	0.9961	Possible inference from the K-ATP opener class (as with minoxidil), but unsupported by the data
Hypotrichosis simplex of the scalp	0.9951	Rare genetic condition; relevance of a vasodilator mechanism is uncertain
Congenital hypotrichosis milia	0.9951	Likely a similarity the TxGNN model (deep learning) learned between related diseases; no demonstrated mechanism
Diffuse alopecia areata	0.9948	Autoimmune condition; a vasodilator is not an established treatment route
Osteoarthritis	0.9940	Any link would be speculative

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.