Iopamidol
Iopamidol, Isovue (iopamidol) is a small molecule pharmaceutical. Iopamidol was first approved as Isovue-m 200 on 1985-12-31.
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Commercial
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Trade Name
FDA
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Iopamidol, Isovue (discontinued: Iopamidol, Isovue)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Iopamidol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISOVUE-M 200 | Bracco Diagnostics | N-018735 RX | 1985-12-31 | 1 products, RLD, RS |
| ISOVUE-300 | Bracco Diagnostics | N-018735 RX | 1985-12-31 | 1 products, RLD, RS |
| ISOVUE-370 | Bracco Diagnostics | N-018735 RX | 1985-12-31 | 1 products, RLD, RS |
| ISOVUE-M 300 | Bracco Diagnostics | N-018735 RX | 1985-12-31 | 1 products, RLD, RS |
| ISOVUE-200 | Bracco Diagnostics | N-018735 RX | 1987-07-07 | 1 products, RLD, RS |
| ISOVUE-250 | Bracco Diagnostics | N-018735 RX | 1992-07-06 | 1 products, RLD, RS |
| ISOVUE-300 | Bracco Diagnostics | N-020327 RX | 1994-10-12 | 1 products, RLD, RS |
| ISOVUE-370 | Bracco Diagnostics | N-020327 RX | 1994-10-12 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| iopamidol | ANDA | 2026-07-23 |
| isovue | New Drug Application | 2026-03-10 |
| isovue-m | New Drug Application | 2026-02-10 |
| isovue-m 200 | New Drug Application | 2017-01-17 |
Indications
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Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | 2 | 2 | 5 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | — | 1 | 3 | 5 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | 1 | 3 | — | 5 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | 2 | 1 | 4 |
| Coronary stenosis | D023921 | EFO_1000882 | — | — | — | — | 3 | — | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | 2 | — | 3 |
| Chronic pain | D059350 | — | — | — | — | — | 1 | 1 | 2 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | 2 | — | 2 |
| Acute kidney injury | D058186 | — | N17 | — | — | 1 | 1 | — | 2 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | 1 | — | 1 | 3 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | 1 | — | 1 | 3 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | 1 | — | 1 | 2 |
| Computed tomography angiography | D000072226 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | 1 | 2 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | — | — | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Duodenal neoplasms | D004379 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | 1 | 3 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 3 | 3 |
| Coronary disease | D003327 | — | — | — | — | — | — | 2 | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 1 | 1 |
| Intraoperative complications | D007431 | — | — | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Gallstones | D042882 | EFO_0004210 | — | — | — | — | — | 1 | 1 |
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | — | — | 1 | 1 |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | — | 1 | 1 |
| Cholecystolithiasis | D041761 | EFO_1000864 | — | — | — | — | — | 1 | 1 |
| Biliary tract diseases | D001660 | EFO_0009534 | K83.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Iopamidol |
| INN | iopamidol |
| Description | Iopamidol is a benzenedicarboxamide compound having N-substituted carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and a (2S)-2-hydroxypropanamido group at the 5-position. It has a role as a radioopaque medium, an environmental contaminant and a xenobiotic. It is a benzenedicarboxamide, an organoiodine compound and a pentol. |
| Classification | Small molecule |
| Drug class | iodine-containing contrast media |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I |
Identifiers
| PDB | — |
| CAS-ID | 60166-93-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200932 |
| ChEBI ID | 31711 |
| PubChem CID | 65492 |
| DrugBank | DB08947 |
| UNII ID | JR13W81H44 (ChemIDplus, GSRS) |
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Trends
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Safety
Black-box Warning
Black-box warning for: Isovue
Adverse Events
Top Adverse Reactions
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4,388 adverse events reported
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