Isosorbide mononitrate
Bidil, Ismotic, Isordil, Isosorbide, Monoket (isosorbide mononitrate) is a small molecule pharmaceutical. Isosorbide mononitrate was first approved as Ismotic on 1982-01-01. It is used to treat angina pectoris, coronary disease, cyanosis, diffuse esophageal spasm, and gastroesophageal reflux amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Monoket
Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isosorbide mononitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MONOKET | Genus Lifesciences | N-020215 RX | 1993-06-30 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ismo | 2007-03-31 | |
| ismotic | 2006-03-23 | |
| isosorbide | ANDA | 2017-07-06 |
| isosorbide mononitrate | ANDA | 2025-12-02 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
179 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | — | 2 |
| Hyperkalemia | D006947 | — | E87.5 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isosorbide mononitrate |
| INN | isosorbide mononitrate |
| Description | Isosorbide mononitrate is a nitrate ester and a glucitol derivative. It has a role as a nitric oxide donor and a vasodilator agent. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=[N+]([O-])O[C@@H]1CO[C@@H]2[C@@H](O)CO[C@H]12 |
Identifiers
| PDB | — |
| CAS-ID | 16051-77-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1311 |
| ChEBI ID | 6062 |
| PubChem CID | 27661 |
| DrugBank | DB01020 |
| UNII ID | LX1OH63030 (ChemIDplus, GSRS) |
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Estimated US medical usage
Isosorbide mononitrate
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Safety
Black-box Warning
No Black-box warning
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13,330 adverse events reported
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