Iobenguane i 131
Azedra (iobenguane i 131) is a small molecule pharmaceutical. Iobenguane i 131 was first approved as Iobenguane sulfate i 131 on 1994-03-25.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Iobenguane i-131
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AZEDRA | Progenics Pharmaceuticals | N-209607 DISCN | 2018-07-30 | 1 products, RLD |
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Iobenguane sulfate i-131
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IOBENGUANE SULFATE I 131 | Sun Pharmaceutical Industries | N-020084 DISCN | 1994-03-25 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adreview | New Drug Application | 2024-01-10 |
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FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
IOBENGUANE I-131, AZEDRA, PROGENICS PHARMS INC | |||
| 2025-07-30 | ODE-204 | ||
Patent Expiration
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ATC Codes
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09I: Tumour detection radiopharmaceuticals
— V09IX: Other diagnostic radiopharmaceuticals for tumour detection in atc
— V09IX02: Iobenguane (131i)
— V10: Therapeutic radiopharmaceuticals
— V10X: Other therapeutic radiopharmaceuticals in atc
— V10XA: Iodine (131i) compounds
— V10XA02: Iobenguane (131i)
HCPCS
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Clinical
Clinical Trials
61 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 | — | 1 | 1 | — | 3 |
| Left ventricular dysfunction | D018487 | — | — | — | — | — | 1 | — | 1 |
| Ventricular dysfunction | D018754 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 12 | 17 | 2 | — | 10 | 39 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 5 | 3 | 1 | — | 2 | 9 |
| Ganglioneuroblastoma | D018305 | — | — | 1 | 1 | 1 | — | — | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pheochromocytoma | D010673 | — | — | 4 | 6 | — | — | 8 | 16 |
| Paraganglioma | D010235 | — | — | 4 | 4 | — | — | 4 | 10 |
| Neoplasms | D009369 | — | C80 | 2 | 4 | — | — | — | 5 |
| Retinoblastoma | D012175 | — | — | 1 | 1 | — | — | — | 2 |
| Primitive neuroectodermal tumors | D018242 | — | — | — | 2 | — | — | — | 2 |
| Neuroectodermal tumors | D017599 | — | — | — | 2 | — | — | — | 2 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | — | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | — | — | — | — | 1 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | — | — | — | — | 1 |
| Carcinoid tumor | D002276 | — | D3A.00 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Implantable defibrillators | D017147 | EFO_0010674 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Iobenguane i 131 |
| INN | iobenguane (131i) |
| Description | 2-[(3-iodophenyl)methyl]guanidine is an organoiodine compound. |
| Classification | Small molecule |
| Drug class | iodine-containing contrast media |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N=C(N)NCc1cccc([131I])c1 |
Identifiers
| PDB | — |
| CAS-ID | 77679-27-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1615779 |
| ChEBI ID | — |
| PubChem CID | 60860 |
| DrugBank | DB06704 |
| UNII ID | Q461L7AK4R (ChemIDplus, GSRS) |
Target
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Safety
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208 adverse events reported
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