MedPath

Nicorandil

Generic Name
Nicorandil
Drug Type
Small Molecule
Chemical Formula
C8H9N3O4
CAS Number
65141-46-0
Unique Ingredient Identifier
260456HAM0

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.
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