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gallium (68Ga) gozetotide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| peptides and glycopeptides | 5429 | 1906894-20-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ga-68 PSMA-11 is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Ga-68 PSMA-11 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT2,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,IKBKB,ITK,JAK1,JAK2,JAK3,KDR,KIT,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 62 | |||
| kinase-selectivity-class | AXL,BRAF,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,MAPK8,PIK3CD,PRKDC,STK33,TEK,TGFBR1 | 14 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 1, 2020 | FDA | UNIV CA LOS ANGELES | |
| Dec. 9, 2022 | EMA | NOVARTIS EUROPHARM LIMITED |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Injection site pain | 46.38 | 46.16 | 8 | 3 | 57790 | 42563534 |
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V09IX14 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS TUMOUR DETECTION Other diagnostic radiopharmaceuticals for tumour detection |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
V09IX Other diagnostic radiopharmaceuticals for tumour detection 10 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography | indication | 82918005 |
🐶 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| N/A | LOCAMETZ | NOVARTIS | N215841 | March 23, 2022 | RX | POWDER | INTRAVENOUS | 11369590 | Aug. 15, 2028 | FOR USE AFTER RADIOLABELING WITH GALLIUM-68, FOR POSITRON EMISSION TOMOGRAPHY OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE LESIONS IN MEN WITH PROSTATE CANCER |
| N/A | LOCAMETZ | NOVARTIS | N215841 | March 23, 2022 | RX | POWDER | INTRAVENOUS | 12109277 | March 9, 2036 | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE LESIONS IN MEN WITH PROSTATE CANCER |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Prostate-specific antigen | Surface antigen | BINDING AGENT | Kd | 7.57 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Glutamate carboxypeptidase 2 | Enzyme | Ki | 10.74 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| C3656970 | UMLSCUI |
| CHEBI:758625 | CHEBI |
| CHEMBL5095039 | ChEMBL_ID |
| 154572876 | PUBCHEM_CID |
| DB16019 | DRUGBANK_ID |
| CHEMBL3578202 | ChEMBL_ID |
| 1366302-52-4 | SECONDARY_CAS_RN |
| 349518 | MMSL |
| 357934 | MMSL |
| 37773 | MMSL |
| 40565 | MMSL |
| d09454 | MMSL |
| d09871 | MMSL |
| 018581 | NDDF |
| 018925 | NDDF |
| 2586016 | RXNORM |
| 9AG41L3AOQ | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LOCAMETZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-1224 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 ug | INTRAVENOUS | NDA | 27 sections |