Pluvicto, Lumark(lutetium lu 177 vipivotide tetraxetan)
EndolucinBeta, Lumark, Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a small molecule pharmaceutical. Lutetium lu 177 vipivotide tetraxetan was first approved as Lumark on 2015-06-18. It has been approved in Europe to treat radionuclide imaging.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| diagnosis | D003933 |
Trade Name
FDA
EMA
Pluvicto
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 vipivotide tetraxetan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PLUVICTO | Advanced Accelerator Applications | N-215833 RX | 2022-03-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pluvicto | New Drug Application | 2023-02-14 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, PLUVICTO, AAA USA NOVARTIS | |||
| 2027-03-23 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | 5 | 6 | — | — | 1 | 10 | ||
| Neoplasms | D009369 | C80 | — | 2 | — | — | — | 2 | |
| Adenocarcinoma | D000230 | 2 | 1 | — | — | — | 2 | ||
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | — | 1 | — | — | — | 1 |
| Neoplasms by site | D009371 | — | 1 | — | — | — | 1 | ||
| Prostatic diseases | D011469 | N42.9 | — | 1 | — | — | — | 1 | |
| Male genital neoplasms | D005834 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenoid cystic carcinoma | D003528 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN |
| INN | — |
| Description | EndolucinBeta, Lumark, Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a small molecule pharmaceutical. Lutetium lu 177 vipivotide tetraxetan was first approved as Lumark on 2015-06-18. It has been approved in Europe to treat radionuclide imaging. |
| Classification | Small molecule |
| Drug class | peptides: (prostate-specific membrane antigen) PSMA binding peptide; chelating agents |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594406 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 104 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8 adverse events reported
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