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Drug

Nicorandil

Regulatory activity · MHRA
Emerging researchLate-stage development

Also known as 2-Nicotinamidoethyl nitrate, N-(2-Hydroxyethyl)nicotinamide nitrate, N-(2-Hydroxyethyl)nicotinamide nitrate (ester), Nicorandilum.

RxNorm31748ChEMBLCHEMBL284906UNII260456HAM0
1
Research papers
5
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Open Label, Parallel-group 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

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis

Clinical trial2026-06-18Results expected Q1 2027 · ClinicalTrials.gov

Evaluating the Effects of Nicorandil on Microvascular Dysfunction in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Clinical trial2026-03-12Results expected Q4 2026 · ClinicalTrials.gov

Safety and Modulation of ABCC9 Pathways by Nicorandil for the Treatment of Hippocampal Sclerosis of Aging: SMArT-HS

Clinical trial2025-12-15Results expected Q3 2026 · ClinicalTrials.gov

Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI

Clinical trial2025-03-01Completed · ClinicalTrials.gov

Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus

Clinical trial2025-02-01Primary completion · ClinicalTrials.gov

Impact of Intravenous Administration of Nicorandil as Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial

Clinical trial2024-12-31Completed · ClinicalTrials.gov

Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

The Preventive Effect of Combined Intracoronary of Nicorandil and Verapamil on Myocardial Injury in Preioperative Period of PCI

Clinical trial2023-05-17Primary completion · ClinicalTrials.gov

Drug Safety Update: Nicorandil (Ikorel): now second-line treatment for angina - risk of ulcer complications

Regulatory2016-01-21MHRA

Drug Safety Update: Nicorandil: risk of gastrointestinal ulceration

Regulatory2014-12-11MHRA

Intravenous nicorandil can preserve microvascular integrity and myocardial viability in patients with reperfused anterior wall myocardial infarction.

Research1999-03-01Journal of the American College of Cardiology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nicorandil
Aliases & brands
2-Nicotinamidoethyl nitrateN-(2-Hydroxyethyl)nicotinamide nitrateN-(2-Hydroxyethyl)nicotinamide nitrate (ester)Nicorandilum
RxNorm CUI
31748
ChEMBL ID
CHEMBL284906
UNII
260456HAM0
Regulatory jurisdictions
mhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
2
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2016-01-21Safety communicationSafety
Drug Safety Update: Nicorandil (Ikorel): now second-line treatment for angina - risk of ulcer complications
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Nicorandil: risk of gastrointestinal ulceration
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

26 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
26
registered trials across all phases
LATEST COMPLETION 2025
5
Active studies
3
Recruiting
22
Late-stage (III+)
9
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 26
Phase 1 / 21Phase 23Phase 2 / 31Phase 33Phase 414Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Evaluating the Effects of Nicorandil on Microvascular Dysfunction in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Not yet recruitingPH IVChina National Center for Cardiovascular Diseasesn=1702027

A Randomized, Open Label, Parallel-group 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

RecruitingPH IVKorea University Anam Hospitaln=4602026

Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis

Active, not recruitingPH IVKumamoto Universityn=2682026

Impact of Intravenous Administration of Nicorandil as Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial

CompletedPH IVKey trialFudan Universityn=1,5002024

Effects of Nicorandil on Cardiac Sympathetic Nerve Activity and Distribution in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

Unknown statusPH IVXuzhou Central Hospitaln=802022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI

CompletedPH I/IIAin Shams Universityn=3002025

Impact of Intravenous Administration of Nicorandil as Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial

CompletedPH IVKey trialFudan Universityn=1,5002024

Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

CompletedPH IVChinese PLA General Hospitaln=2382021

The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

CompletedPH IVPeking University Third Hospitaln=612020

Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects

CompletedN/AUniversity of Copenhagenn=162020

A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

CompletedPH IVMerck KGaA, Darmstadt, Germanyn=4022014

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Journal of the American College of Cardiology1
Leading researchers
  • Fujii K1
  • Higashino Y1
  • Hori M1
  • Ito H1
  • Iwakura K1
  • Kuzuya T1
  • Masuyama T1
  • Minamino T1
Leading institutions
free-text, unnormalised
  • Sakurabashi Watanabe Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.