Overview

Nicorandil is an orally efficacious vasodilatory drug and antianginal agent marketed in the UK, Australia, most of Europe, India, Philippines, Japan, South Korea, and Taiwan. It is not an approved drug by FDA. It is a niacinamide derivative that induces vasodilation of arterioles and large coronary arteries by activating potassium channels. It is often used for patients with angina who remain symptomatic despite optimal treatment with other antianginal drugs . Nicorandil is a dual-action potassium channel opener that relaxes vascular smooth muscle through membrane hyperpolarization via increased transmembrane potassium conductance and increased intracellular concentration of cyclic GMP. It is shown to dilate normal and stenotic coronary arteries and reduces both ventricular preload and afterload .

Indication

Indicated for the prevention and treatment of chronic stable angina pectoris and reduction in the risk of acute coronary syndromes.

Associated Conditions

Angina Pectoris

Research Report

Published: Aug 29, 2025

Nicorandil (DB09220): A Comprehensive Pharmacological and Clinical Monograph

Executive Summary

Nicorandil is a unique anti-anginal agent distinguished by a rationally designed dual mechanism of action, functioning as both an adenosine triphosphate (ATP)-sensitive potassium (KATP) channel activator and a nitric oxide (NO) donor.[1] This hybrid pharmacology confers a balanced vasodilator effect, reducing both cardiac preload through venodilation and afterload through arterial dilation, thereby improving the myocardial oxygen supply-demand balance.[3] Its primary indication is the prevention and long-term treatment of chronic stable angina pectoris.[5] However, its therapeutic role has been redefined in many regions, including the United Kingdom and the European Union, where it is now recommended as a second-line therapy. This repositioning is a direct consequence of a significant and serious risk of muco-cutaneous ulcerations, which can be severe, treatment-refractory, and may lead to complications such as perforation and fistula formation.[7] The only effective management for these ulcers is the cessation of nicorandil therapy.

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Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI	2025/08/24	NCT07138508	Not Applicable	Completed	Ain Shams University
Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI	2025/01/22	NCT06787430	Phase 4	Not yet recruiting	China National Center for Cardiovascular Diseases
Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus	2024/05/28	NCT06430125	Phase 3	Recruiting	Tanta University
Effect of Nicorandil in Type 2 Diabetic Obese Patients	2024/05/21	NCT06423729	Phase 2	Recruiting	Tanta University
Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer	2023/07/20	NCT05954871	Phase 1	Active, not recruiting	Genentech, Inc.
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors	2022/08/04	NCT05487235	Phase 1	Completed	Genentech, Inc.
A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT ReductioN of DecREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease	2022/06/22	NCT05427786	Phase 4	Recruiting	Korea University Anam Hospital
Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury	2022/06/01	NCT05399576	Phase 2	UNKNOWN	The First Affiliated Hospital of Zhejiang Chinese Medical University
The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion	2021/10/21	NCT05087797	Phase 4	Completed	Peking University Third Hospital
Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction	2021/04/01	NCT04826497	Phase 4	UNKNOWN	Xuzhou Central Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NICORANDIL-WGR nicorandil 10 mg tablet blister pack	277344	GM Pharma International Pty Ltd	Medicine	A	10/3/2017
IKOTAB nicorandil 20 mg tablet blister pack	218689	Viatris Pty Ltd	Medicine	A	11/14/2014
IKOTAB nicorandil 10 mg tablet blister pack	218690	Viatris Pty Ltd	Medicine	A	11/14/2014
APO-NICORANDIL nicorandil 10 mg tablet blister pack	277346	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/3/2017
NICORANDIL-WGR nicorandil 20 mg tablet blister pack	277345	GM Pharma International Pty Ltd	Medicine	A	10/3/2017
APO-NICORANDIL nicorandil 20 mg tablet blister pack	277343	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/3/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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