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Isosorbide mononitrate

Generic Name
Isosorbide mononitrate
Brand Names
Imdur, Ismo, Monoket
Drug Type
Small Molecule
Chemical Formula
C6H9NO6
CAS Number
16051-77-7
Unique Ingredient Identifier
LX1OH63030

Overview

Isosorbide mononitrate is an organic nitrate with vasodilating properties. It is an anti-anginal agent that works by relaxing the smooth muscles of both arteries and veins, but but predominantly veins to reduce cardiac preload. Isosorbide mononitrate is an active metabolite of isosorbide dinitrate. Like other organic nitrates, isosorbide mononitrate acts as a prodrug for its active metabolite, nitric oxide, which mediates the therapeutic action of isosorbide mononitrate. Isosorbide mononitrate has a longer duration of action than nitroglycerin due to its slow onset of absorption and metabolism. First approved by the FDA in 1991, isosorbide mononitrate is used for the prevention and management of angina pectoris caused by coronary artery disease; however, the onset of action of orally-administered isosorbide mononitrate is not rapid enough to offset an acute anginal episode. It is available in oral tablets generically and under the brand name ISMO and Monoket. The extended-release forms of the drug are also available generically and under the brand name Imdur.

Indication

Isosorbide mononitrate is indicated for the prevention and management of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid to be useful in aborting an acute anginal episode.

Associated Conditions

  • Angina Pectoris

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/04/22
Early Phase 1
UNKNOWN
2021/01/28
Phase 1
Withdrawn
Biolab Sanus Farmaceutica
2020/03/18
Phase 3
Completed
2019/08/09
Phase 2
Terminated
2019/02/26
Phase 2
UNKNOWN
Abdelrahman Ali Fadel Youssef Mohamed
2018/09/11
Phase 3
Completed
ahmed nagy shaker ramadan
2018/07/16
Not Applicable
UNKNOWN
2018/06/15
Phase 1
Completed
2018/06/04
Phase 4
Completed
ahmed nagy shaker ramadan
2018/03/02
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Torrent Pharmaceuticals Limited
13668-104
ORAL
30 mg in 1 1
1/8/2024
Bryant Ranch Prepack
71335-2192
ORAL
60 mg in 1 1
11/22/2021
REMEDYREPACK INC.
70518-1485
ORAL
10 mg in 1 1
2/21/2024
Chartwell RX, LLC
62135-587
ORAL
60 mg in 1 1
5/2/2023
REMEDYREPACK INC.
70518-3585
ORAL
30 mg in 1 1
1/15/2024
Major Pharmaceuticals
0904-6450
ORAL
60 mg in 1 1
4/17/2023
Aphena Pharma Solutions - Tennessee, LLC
71610-337
ORAL
60 mg in 1 1
8/20/2019
Northwind Pharmaceuticals, LLC
51655-922
ORAL
30 mg in 1 1
12/18/2023
Bryant Ranch Prepack
71335-2194
ORAL
30 mg in 1 1
11/22/2021
A-S Medication Solutions
50090-2077
ORAL
60 mg in 1 1
12/12/2016

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
IMDEX CR TABLET 60 mg
SIN10515P
TABLET, FILM COATED
60mg
12/8/1998
IMDUR DURULES TABLET 60 mg
SIN01996P
TABLET, FILM COATED
60 mg
6/24/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
5-ISM-Sustained-release pellets
国药准字H20001197
化学药品
制剂中间体
4/26/2020
Isosorbide Mononitrate Sustained-release Capsules (Ⅳ)
国药准字H20031223
化学药品
胶囊剂(缓释胶囊)
8/27/2020
Isosorbide Mononitrate Sustained-release Capsules (Ⅳ)
国药准字H20031224
化学药品
胶囊剂(缓释胶囊)
8/27/2020
Isosorbide Mononitrate for Injection
国药准字H20020123
化学药品
注射剂(冻干)
5/22/2020
Isosorbide Mononitrate for Injection
国药准字H20060653
化学药品
注射剂(冻干粉针剂)
4/13/2020
Isosorbide Mononitrate for Injection
国药准字H20020315
化学药品
注射剂(冻干粉针剂)
4/13/2020
Isosorbide Mononitrate for Injection
国药准字H20061160
化学药品
注射剂
1/7/2021
Isosorbide Mononitrate for Injection
国药准字H20020638
化学药品
注射剂
8/28/2020
Isosorbide Mononitrate for Injection
国药准字H20061161
化学药品
注射剂
1/7/2021
Isosorbide Mononitrate for Injection
国药准字H20020639
化学药品
注射剂
9/1/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
SORBIMON PROLONGED-RELEASE TABLETS 60MG
N/A
N/A
N/A
3/28/2025
IMDUR DURULES TAB 60MG
N/A
N/A
N/A
11/20/1989

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