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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
2025/08/13
Not Applicable
Active, not recruiting
Raid M. Al-Ani
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Withdrawn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

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
71335-2532
ORAL
60 mg in 1 1
8/26/2025
Bryant Ranch Prepack
71335-2194
ORAL
30 mg in 1 1
11/22/2021

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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS-ISMN
02301288
Tablet (Extended-Release) - Oral
60 MG
11/8/2007
ISMN
sivem pharmaceuticals ulc
02446073
Tablet (Extended-Release) - Oral
60 MG
10/8/2015
APO-ISMN
02272830
Tablet (Extended-Release) - Oral
60 MG
3/3/2006
IMDUR
Juno Pharmaceuticals Corp.
02126559
Tablet (Extended-Release) - Oral
60 MG
12/31/1994
PRO-ISMN - 60
PRO DOC LIMITEE
02311321
Tablet (Extended-Release) - Oral
60 MG
7/4/2008
ISMO TAB 20MG
wyeth-ayerst canada inc.
02058472
Tablet - Oral
20 MG
12/31/1994
PHL-ISMN
pharmel inc
02307731
Tablet (Extended-Release) - Oral
60 MG
N/A
DOM-ISMN
dominion pharmacal
02307758
Tablet (Extended-Release) - Oral
60 MG
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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