Lutetium dotatate lu-177
EndolucinBeta, Lumark (lutetium dotatate lu-177) is an unknown pharmaceutical. Lutetium dotatate lu-177 was first approved as Lumark on 2015-06-18. It has been approved in Europe to treat radionuclide imaging.
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Commercial
Trade Name
FDA
EMA
Lutathera
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lutetium lu 177 dotatate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUTATHERA | Advanced Accelerator Applications | N-208700 RX | 2018-01-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lutathera | New Drug Application | 2024-12-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pancreatic neoplasms | EFO_0003860 | D010190 | C25 |
| gastrointestinal neoplasms | — | D005770 | C26.9 |
| neuroendocrine tumors | EFO_1001901 | D018358 | D3A.8 |
Agency Specific
FDA
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Clinical
Clinical Trials
100 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | 1 | — | — | 3 | 5 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | 1 | — | — | — | 1 |
| Small cell lung carcinoma | D055752 | — | — | 1 | 1 | — | — | — | 1 |
| Nasopharyngeal carcinoma | D000077274 | — | — | — | 1 | — | — | — | 1 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lutetium dotatate lu-177 |
| INN | — |
| Description | Lutetium (177Lu) oxodotreotide (INN) or 177Lu DOTA-TATE, trade name Lutathera, is a chelated complex of a radioisotope of the element lutetium with DOTA-TATE, used in peptide receptor radionuclide therapy (PRRT). Specifically, it is used in the treatment of cancers which express somatostatin receptors.
|
| Classification | Unknown |
| Drug class | Antineoplastic agent |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989924 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13985 |
| UNII ID | — |
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Safety
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4,504 adverse events reported
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