Isosorbide mononitrate
Bidil, Ismotic, Isordil, 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
Trade Name
FDA
EMA
Isordil, Monoket (generic drugs available since 1987-03-12, discontinued: Dilatrate-sr, Imdur, Ismo, Ismotic, Sorbitrate)
CombinationsBidil (generic drugs available since 1987-03-12)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydralazine hydrochloride
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Isosorbide dinitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BIDIL | Azurity | N-020727 RX | 2005-06-23 | 1 products, RLD, RS |
Isosorbide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISMOTIC | Alcon Research | N-017063 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Isosorbide dinitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISORDIL | Bausch Health Companies | N-012093 RX | 1988-07-29 | 2 products, RLD |
Show 7 discontinued
Isosorbide mononitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MONOKET | ECI Pharmaceuticals | N-020215 RX | 1993-06-30 | 2 products, RLD |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bidil | New Drug Application | 2022-07-19 |
| ismotic | 2006-03-23 | |
| isordil | New Drug Application | 2019-08-08 |
| isosorbide mononitrate | ANDA | 2022-10-31 |
| monoket | New Drug Application | 2015-02-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| angina pectoris | EFO_0003913 | D000787 | I20 |
| coronary disease | — | D003327 | — |
| cyanosis | — | D003490 | R23.0 |
| diffuse esophageal spasm | EFO_1001785 | D015155 | K22.4 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| heart failure | EFO_0003144 | D006333 | I50 |
| poisoning | EFO_0008546 | D011041 | T65.91 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
68 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 2 | 1 | 3 | 1 | 8 |
| Coronary disease | D003327 | — | — | 1 | 2 | 1 | 4 | ||
| Coronary artery disease | D003324 | I25.1 | 1 | — | — | 3 | — | 4 | |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | 1 | 1 | 2 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | — | — | 1 | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 1 | — | 1 |
| Coronary stenosis | D023921 | EFO_1000882 | — | — | — | 1 | — | 1 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | 1 | — | 1 |
| Premature obstetric labor | D007752 | O60 | — | — | — | 1 | — | 1 | |
| Coronary artery bypass | D001026 | EFO_0003776 | — | — | — | 1 | — | 1 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral small vessel diseases | D059345 | — | 2 | 1 | — | — | 2 | ||
| Cardio-renal syndrome | D059347 | — | — | 1 | — | 1 | 2 | ||
| Contraception | D003267 | — | — | 1 | — | — | 1 | ||
| Rupture | D012421 | — | — | 1 | — | — | 1 | ||
| Lacunar stroke | D059409 | I63.81 | — | 1 | 1 | — | — | 1 | |
| Diabetic foot | D017719 | EFO_1001459 | — | — | 1 | — | — | 1 | |
| Oligohydramnios | D016104 | EFO_0007401 | O41.0 | — | 1 | 1 | — | — | 1 |
| Stable angina | D060050 | I20.8 | — | — | 1 | — | — | 1 | |
| Left ventricular dysfunction | D018487 | — | — | 1 | — | — | 1 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 2 | — | — | — | 4 |
| Cervical ripening | D020070 | — | 1 | — | — | 1 | 2 | ||
| Induced labor | D007751 | 1 | 2 | — | — | — | 2 | ||
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | — | — | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | 1 | 1 | — | — | — | 1 |
| Orthostatic intolerance | D054971 | 1 | 1 | — | — | — | 1 | ||
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | — | — | — | 1 | |
| Missed abortion | D000030 | O02.1 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 2 | 2 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 1 | 1 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | — | 1 | 1 |
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 | 28004 |
| ChEMBL ID | CHEMBL1311 |
| ChEBI ID | 6062 |
| PubChem CID | 27661 |
| DrugBank | DB01020 |
| UNII ID | LX1OH63030 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,075 adverse events reported
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