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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Isordil, Isosorbide, Monoket (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 dinitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISORDIL | Bausch Health Companies | N-012093 RX | 1988-07-29 | 2 products, RLD |
Show 7 discontinued
Isosorbide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISMOTIC | Alcon Research | N-017063 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Isosorbide mononitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MONOKET | Genus Lifesciences | 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 | 2024-10-08 |
| isosorbide dinitrate and hydralazine hydrochloride | NDA authorized generic | 2024-07-01 |
| isosorbide mononitrate | ANDA | 2024-10-28 |
| lisinopril | ANDA | 2012-10-12 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
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
HCPCS
No data
Clinical
Clinical Trials
133 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 32 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 4 | 1 | — | — | 6 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | 1 | — | — | 3 |
| 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 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 2 | 4 | — | — | — | 4 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 3 | — | — | — | 4 |
| Lymphoma | D008223 | — | C85.9 | 2 | 3 | — | — | — | 4 |
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | — | 3 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 3 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | 2 | — | — | — | 3 |
| Follicular lymphoma | D008224 | — | C82 | 1 | 2 | — | — | — | 3 |
| Small cell lung carcinoma | D055752 | — | — | 2 | 2 | — | — | — | 3 |
Show 27 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 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | — | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | 1 | — | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | — | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 1 | — | — | — | — | 1 |
Show 12 more
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 22 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 8,905 documents
View more details
Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
14,250 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use