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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/01/22 | Phase 4 | Not yet recruiting | China National Center for Cardiovascular Diseases | ||
2024/05/28 | Phase 3 | Recruiting | |||
2024/05/21 | Phase 2 | Recruiting | |||
2023/07/20 | Phase 1 | Active, not recruiting | |||
2022/08/04 | Phase 1 | Completed | |||
2022/06/22 | Phase 4 | Recruiting | |||
2022/06/01 | Phase 2 | UNKNOWN | The First Affiliated Hospital of Zhejiang Chinese Medical University | ||
2021/10/21 | Phase 4 | Completed | |||
2021/04/01 | Phase 4 | UNKNOWN | Xuzhou Central Hospital | ||
2020/12/11 | Phase 4 | Completed |
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 |
---|---|---|---|---|---|
Nicorandil for Injection | 国药准字HJ20240010 | 化学药品 | 注射剂 | 4/24/2024 | |
Nicorandil for Injection | 国药准字H20249843 | 化学药品 | 注射剂 | 12/25/2024 | |
Nicorandil for Injection | 国药准字H20253307 | 化学药品 | 注射剂 | 1/24/2025 | |
Nicorandil for Injection | 国药准字H20243669 | 化学药品 | 注射剂 | 5/8/2024 | |
Nicorandil for Injection | 国药准字H20253403 | 化学药品 | 注射剂 | 2/20/2025 | |
Nicorandil for Injection | 国药准字H20253473 | 化学药品 | 注射剂 | 2/25/2025 | |
Nicorandil for Injection | 国药准字H20253404 | 化学药品 | 注射剂 | 2/20/2025 | |
Nicorandil for Injection | 国药准字H20243362 | 化学药品 | 注射剂 | 6/4/2024 | |
Nicorandil for Injection | 国药准字H20247283 | 化学药品 | 注射剂 | 11/12/2024 | |
Nicorandil for Injection | 国药准字H20247272 | 化学药品 | 注射剂 | 11/7/2024 |
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 | Medicine | A | 10/3/2017 | |
IKOTAB nicorandil 20 mg tablet blister pack | 218689 | Medicine | A | 11/14/2014 | |
IKOTAB nicorandil 10 mg tablet blister pack | 218690 | Medicine | A | 11/14/2014 | |
APO-NICORANDIL nicorandil 10 mg tablet blister pack | 277346 | Medicine | A | 10/3/2017 | |
NICORANDIL-WGR nicorandil 20 mg tablet blister pack | 277345 | Medicine | A | 10/3/2017 | |
APO-NICORANDIL nicorandil 20 mg tablet blister pack | 277343 | Medicine | A | 10/3/2017 |