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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

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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

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

EMA Drug Approvals

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

HSA Drug Approvals

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Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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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

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

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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