lutetium (177Lu) vipivotide tetraxetan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5509 1703749-62-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lutetium (177Lu) vipivotide tetraxetan
  • pluvicto
  • 177Lu-PSMA-617
  • JK-218
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer, including mCRPC. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA- expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.
  • Molecular weight: 1216.07
  • Formula: C49H68LuN9O16
  • CLOGP: -12.02
  • LIPINSKI: 3
  • HAC: 25
  • HDO: 8
  • TPSA: 336.30
  • ALOGS: -4.32
  • ROTB: 27

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 23, 2022 FDA AAA USA NOVARTIS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
MeSH PA D064907 Diagnostic Uses of Chemicals
MeSH PA D007202 Indicators and Reagents
MeSH PA D019275 Radiopharmaceuticals

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
PSMA-positive metastatic castration-resistant prostate cancer indication 427492003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
27mCi/ML PLUVICTO AAA USA NOVARTIS N215833 March 23, 2022 RX SOLUTION INTRAVENOUS 10406240 Aug. 15, 2028 FOR TREATMENT OF ADULT PATIENTS WITH PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR (AR) PATHWAY INHIBITION AND TAXANE-BASED CHEMOTHERAPY
27mCi/ML PLUVICTO AAA USA NOVARTIS N215833 March 23, 2022 RX SOLUTION INTRAVENOUS 11318121 Aug. 15, 2028 FOR TREATMENT OF ADULT PATIENTS WITH PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR (AR) PATHWAY INHIBITION AND TAXANE-BASED CHEMOTHERAPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
27mCi/ML PLUVICTO AAA USA NOVARTIS N215833 March 23, 2022 RX SOLUTION INTRAVENOUS March 23, 2027 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostate-specific antigen Surface antigen BINDING AGENT Kd 8.33 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL4594406 ChEMBL_ID
C000610110 MESH_SUPPLEMENTAL_RECORD_UI
122706785 PUBCHEM_CID
2597047 RXNORM
40557 MMSL
d09868 MMSL
C4308025 UMLSCUI
D12335 KEGG_DRUG
018885 NDDF
4YM1W0EGQ5 UNII
7P5C02S4X8 UNII
G6UF363ECX UNII
UH4J18XEL3 UNII
11010 INN_ID
11429 INN_ID

Pharmaceutical products:

None