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
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Trade Name
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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
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydralazine hydrochloride
+
Isosorbide dinitrate
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 | OMNIVIUM PHARMS | 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 |
| dilatrate-sr | 2008-01-23 | |
| ismo | 2007-03-31 | |
| ismotic | 2006-03-23 | |
| isordil | New Drug Application | 2019-08-08 |
| isosorbide | ANDA | 2018-11-30 |
| isosorbide dinitrate | ANDA | 2024-09-24 |
| isosorbide dinitrate and hydralazine hydrochloride | NDA authorized generic | 2024-07-01 |
| isosorbide mononitrate | ANDA | 2024-09-09 |
| lisinopril | ANDA | 2012-10-12 |
Indications
FDA
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Agency Specific
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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
105 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 | HP_0001635 | I50 | 1 | 2 | 3 | 6 | 6 | 18 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | 5 | 7 | 13 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | 1 | 7 | 4 | 13 |
| Coronary disease | D003327 | — | — | 1 | — | 1 | 5 | 3 | 10 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | 3 | 4 | 8 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 2 | 1 | 2 | 1 | 8 |
| Stable angina | D060050 | — | I20.89 | — | — | 1 | 2 | 1 | 4 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | 1 | 2 | — | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | 2 | 1 | 3 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | 2 | 1 | 3 |
Show 31 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | — | — | 1 | — | 1 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | 1 | — | — | 2 |
| Cerebral small vessel diseases | D059345 | — | — | — | 2 | 1 | — | — | 2 |
| Cardio-renal syndrome | D059347 | — | — | — | — | 1 | — | 1 | 2 |
| Ventricular dysfunction | D018754 | — | — | — | — | 1 | — | 1 | 2 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | 1 | 1 | — | — | 2 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | 1 | — | — | 2 |
| Foot ulcer | D016523 | — | — | — | 1 | 1 | — | — | 2 |
| Syndrome | D013577 | — | — | — | — | 1 | — | 1 | 2 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | 1 | — | — | 1 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cervical ripening | D020070 | — | — | — | 1 | — | — | 1 | 2 |
| Induced labor | D007751 | — | — | 1 | 2 | — | — | — | 2 |
| Missed abortion | D000030 | — | O02.1 | 1 | 1 | — | — | — | 2 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | — | — | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | — | 1 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | 1 | 1 | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | 1 | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 1 | — | — | — | 1 |
| Fontan procedure | D018729 | — | — | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | 2 | 7 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Fissure in ano | D005401 | HP_0012390 | K60.2 | 1 | — | — | — | — | 1 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 1 | — | — | — | — | 1 |
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Habitual abortion | D000026 | EFO_1000954 | N96 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 3 | 3 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | — | — | — | 2 | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 2 | 2 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | — | — | 2 | 2 |
| Collateral circulation | D003097 | — | — | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
Show 7 more
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) |
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Isosorbide dinitrate
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Hydralazine
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Isosorbide dinitrate
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Safety
Black-box Warning
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14,295 adverse events reported
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