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
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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
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 | 2020-07-29 |
| dilatrate-sr | 2008-01-23 | |
| ismo | 2007-03-31 | |
| isordil | New Drug Application | 2019-08-08 |
| isosorbide | ANDA | 2021-02-17 |
| isosorbide dinitrate | ANDA | 2024-01-12 |
| isosorbide mononitrate | ANDA | 2024-01-23 |
| lisinopril | ANDA | 2012-10-12 |
| monoket | New Drug Application | 2014-07-16 |
Agency Specific
FDA
EMA
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Patent Expiration
No data
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
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Clinical
Clinical Trials
131 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 | 4 | 6 | 16 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | 3 | 5 | 9 |
| Coronary disease | D003327 | — | — | — | — | 1 | 2 | 1 | 4 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | 2 | 1 | 4 |
| Stable angina | D060050 | — | I20.89 | — | — | 1 | 1 | 1 | 3 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | 2 | 1 | 3 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | — | — | 2 | — | 2 |
| Pulmonary edema | D011654 | EFO_1001134 | J81 | — | — | 1 | 1 | — | 2 |
| Cardiogenic shock | D012770 | — | R57.0 | — | — | — | 1 | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 1 | — | 1 |
Show 14 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 2 | 1 | — | 1 | 6 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | 1 | — | — | 3 |
| Cerebral small vessel diseases | D059345 | — | — | — | 2 | 1 | — | — | 2 |
| Cardio-renal syndrome | D059347 | — | — | — | — | 1 | — | 1 | 2 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | 1 | — | — | 1 |
| 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 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 3 | — | — | — | 4 |
| Follicular lymphoma | D008224 | — | C82 | 1 | 2 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 2 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | 1 | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 1 | — | — | — | 2 |
| Small cell lung carcinoma | D055752 | — | — | 1 | 2 | — | — | — | 2 |
| 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 |
Show 13 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 |
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | — | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 1 | — | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | — | — | — | — | 1 |
Show 7 more
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 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 1 | 1 |
| Collateral circulation | D003097 | — | — | — | — | — | — | 1 | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| 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 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
Show 13 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
Adverse Events
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11,079 adverse events reported
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