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2021/01/28 | Phase 1 | Withdrawn | Biolab Sanus Farmaceutica | ||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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
APO-ISOSORBIDE MONONITRATE 60 mg modified release tablet blister pack | 75240 | Medicine | A | 9/20/2000 | |
ISOBIDE MR isosorbide mononitrate 60 mg modified release tablet blister pack | 184066 | Medicine | A | 4/5/2012 | |
DURIDE Isosorbide mononitrate 60mg tablet blister pack | 60907 | Medicine | A | 10/21/1997 | |
Isosorbide Mononitrate Tablets 60 mg (Bulk) | 202165 | Medicine | A | 10/23/2012 | |
MONODUR isosorbide mononitrate 120 mg modified release tablet blister pack | 64284 | Medicine | A | 7/8/1998 | |
IMDUR isosorbide mononitrate 60 mg modified release tablet blister pack | 46390 | Medicine | A | 12/8/1993 | |
MONODUR isosorbide mononitrate 60 mg modified release tablet blister pack | 59600 | Medicine | A | 7/7/1997 | |
Isosorbide mononitrate tablet 60 mg blister pack | 329862 | Medicine | A | 2/13/2020 | |
IMDUR isosorbide mononitrate 120 mg modified release tablet blister pack | 62795 | Medicine | A | 2/23/1998 | |
ISOSORBIDE-RJIC MR isosorbide mononitrate 60 mg modified release tablet blister pack | 424472 | Medicine | A | 1/3/2024 |
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