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
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Lutathera
Drug Products
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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 | 2024-10-28 |
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 |
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Clinical
Clinical Trials
99 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 19 | 34 | 9 | 2 | 15 | 71 |
| Neoplasms | D009369 | — | C80 | 8 | 14 | 3 | 1 | 2 | 22 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 4 | 1 | 2 | 3 | 12 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | 1 | 2 | 3 | 7 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | 1 | 2 | 3 | 7 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | 4 | 3 | — | 1 | — | 6 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoid tumor | D002276 | — | D3A.00 | — | 2 | 2 | — | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 4 | 1 | — | — | 4 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 3 | 1 | — | — | 3 |
| Endocrine gland neoplasms | D004701 | EFO_0003769 | D35 | — | 2 | 1 | — | 1 | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroendocrine carcinoma | D018278 | — | — | 1 | 11 | — | — | — | 11 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | 1 | 6 | — | — | 3 | 9 |
| Carcinoma | D002277 | — | C80.0 | 1 | 6 | — | — | — | 6 |
| Pheochromocytoma | D010673 | — | — | 1 | 6 | — | — | — | 6 |
| Paraganglioma | D010235 | — | — | 1 | 6 | — | — | — | 6 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 3 | — | — | — | 3 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | — | — | 1 | 3 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | 2 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | 1 | 3 |
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thymoma | D013945 | — | — | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Radiation dosimeters | D000072232 | — | — | — | — | — | — | 1 | 1 |
| Hyperthyroidism | D006980 | — | E05.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | — | — | — | 1 | 1 |
| Digestive system neoplasms | D004067 | — | — | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 1 | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
| Neoplasms by histologic type | D009370 | — | — | — | — | — | — | 1 | 1 |
| Neoplasms by site | D009371 | — | — | — | — | — | — | 1 | 1 |
| Nerve tissue neoplasms | D009380 | — | — | — | — | — | — | 1 | 1 |
| Primitive neuroectodermal tumors | D018242 | — | — | — | — | — | — | 1 | 1 |
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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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3,824 adverse events reported
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