Isosorbide
Bidil, Ismotic, Isordil, Isosorbide, Monoket (isosorbide) is a small molecule pharmaceutical. Isosorbide 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
Isordil, Isosorbide (discontinued: Dilatrate-sr, Imdur, Ismo, Ismotic, Isordil, Isosorbide, Sorbitrate)
CombinationsBidil, Isosorbide hydralazine
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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 |
|---|---|---|---|---|
| ISMO | Promius Pharma | N-019091 DISCN | 1991-12-30 | 1 products |
| IMDUR | Merck & Co | N-020225 DISCN | 1993-08-12 | 3 products, RLD |
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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 | 2025-01-10 |
| isosorbide dinitrate and hydralazine hydrochloride | ANDA | 2025-06-03 |
| isosorbide mononitrate | ANDA | 2025-06-27 |
| lisinopril | ANDA | 2012-10-12 |
Indications
FDA
EMA
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
— C01DA14: Isosorbide mononitrate
— 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
112 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 | 3 | 5 | 6 | 17 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | 5 | 8 | 14 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | 1 | 7 | 5 | 14 |
| Coronary disease | D003327 | — | — | 1 | — | 1 | 5 | 4 | 11 |
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 2 | 1 | 2 | 1 | 9 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | 3 | 4 | 8 |
| Stable angina | D060050 | — | I20.89 | — | — | 1 | 2 | 1 | 4 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | 1 | 2 | — | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 2 | 1 | 3 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | 2 | 1 | 3 |
Show 33 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 | — | 1 | 3 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | 1 | — | 1 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 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 | EFO_0003882 | M81.0 | — | — | 1 | — | — | 1 |
Show 13 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 | — | R80 | — | 1 | — | — | — | 1 |
| Acute kidney injury | D058186 | — | N17 | — | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | — | 1 |
| Tachycardia | D013610 | — | R00.0 | 1 | 1 | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | 1 | 1 | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
Show 5 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 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 1 | — | — | — | — | 1 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 1 | — | — | — | — | 1 |
| Infertility | D007246 | EFO_0000545 | — | 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 | — | R51 | — | — | — | — | 3 | 3 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 2 | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 2 | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | — | — | 2 | 2 |
| Collateral circulation | D003097 | — | — | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
Show 10 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isosorbide |
| INN | isosorbide |
| Description | Isosorbide is an organic molecular entity. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O[C@H]1CO[C@@H]2[C@H](O)CO[C@H]12 |
Identifiers
| PDB | — |
| CAS-ID | 652-67-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200660 |
| ChEBI ID | — |
| PubChem CID | 12597 |
| DrugBank | DB09401 |
| UNII ID | WXR179L51S (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Lisinopril
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15,133 adverse events reported
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