Isosorbide dinitrate
Bidil, Ismotic, Isordil, Isosorbide, Monoket (isosorbide dinitrate) is a small molecule pharmaceutical. Isosorbide dinitrate 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
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Isosorbide (discontinued: Isosorbide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bidil | New Drug Application | 2022-07-19 |
| dilatrate-sr | 2008-01-23 | |
| isordil | New Drug Application | 2019-08-08 |
| isosorbide | ANDA | 2018-11-30 |
| isosorbide dinitrate | ANDA | 2025-09-18 |
| isosorbide dinitrate and hydralazine hydrochloride | ANDA | 2025-06-03 |
| lisinopril | ANDA | 2012-10-12 |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01D: Vasodilators used in cardiac diseases
— C01DA: Organic nitrates used in cardiac disease
— C01DA08: Isosorbide dinitrate
— C01DA58: Isosorbide dinitrate, combinations
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AE: Muscle relaxants for treatment of hemorrhoids and anal fissures for topical use
— C05AE02: Isosorbide dinitrate
HCPCS
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Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary disease | D003327 | — | — | 1 | — | — | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | 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 dinitrate |
| INN | isosorbide dinitrate |
| Description | Isosorbide dinitrate is a nitrate ester and a glucitol derivative. It has a role as a vasodilator agent and a nitric oxide donor. |
| 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]1OC[C@H]2O[N+](=O)[O-] |
Identifiers
| PDB | — |
| CAS-ID | 87-33-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL6622 |
| ChEBI ID | 6061 |
| PubChem CID | 6883 |
| DrugBank | DB00883 |
| UNII ID | IA7306519N (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Isosorbide dinitrate
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Hydralazine
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Isosorbide dinitrate
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Trends
PubMed Central
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Additional graphs summarizing 4,699 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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1,778 adverse events reported
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