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 .
Background
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
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/11/17 | N/A | UNKNOWN | Ahmed Abdel Nasser Abdel Rady | ||
2020/06/29 | Phase 1 | Recruiting | |||
2020/03/17 | Phase 4 | Completed | |||
2020/02/05 | Phase 1 | Completed | |||
2019/10/09 | Phase 2 | Active, not recruiting | Gregory Jicha, MD, PhD | ||
2018/12/14 | Not Applicable | Completed | |||
2018/02/26 | Phase 4 | Completed | Chinese PLA General Hospital | ||
2017/08/17 | Phase 4 | UNKNOWN | |||
2017/01/05 | Phase 4 | Terminated | |||
2016/06/22 | Phase 2 | UNKNOWN |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Nicorandil for Injection | 国药准字H20249369 | 化学药品 | 注射剂 | 11/15/2024 | |
Nicorandil for Injection | 国药准字H20253490 | 化学药品 | 注射剂 | 3/4/2025 | |
Nicorandil for Injection | 国药准字H20253489 | 化学药品 | 注射剂 | 3/4/2025 | |
Nicorandil for Injection | 国药准字H20253491 | 化学药品 | 注射剂 | 3/4/2025 | |
Nicorandil for Injection | 国药准字H20253492 | 化学药品 | 注射剂 | 3/4/2025 | |
Nicorandil for Injection | 国药准字H20253538 | 化学药品 | 注射剂 | 3/4/2025 | |
Nicorandil for Injection | 国药准字H20243212 | 化学药品 | 注射剂 | 2/23/2024 | |
Nicorandil for Injection | 国药准字H20244125 | 化学药品 | 注射剂 | 6/25/2024 | |
Nicorandil for Injection | 国药准字H20253306 | 化学药品 | 注射剂 | 1/24/2025 | |
Nicorandil for Injection | 国药准字H20234690 | 化学药品 | 注射剂 | 12/26/2023 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |