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
EMA
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Clinical
Clinical Trials
104 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 | 20 | 34 | 11 | 2 | 16 | 75 |
| Neoplasms | D009369 | — | C80 | 8 | 14 | 3 | 1 | 2 | 22 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 4 | 2 | 2 | 3 | 13 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | 2 | 2 | 3 | 8 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | 2 | 2 | 3 | 8 |
| 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 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | — | 2 |
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 | — | 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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Additional graphs summarizing 901 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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4,819 adverse events reported
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