gallium (68Ga) gozetotide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 9, 2022 | EMA | NOVARTIS EUROPHARM LIMITED | |
| Dec. 1, 2020 | FDA | UNIV CA LOS ANGELES |
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:
| Source | Code | Description |
|---|---|---|
| ATC | V09IX14 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS TUMOUR DETECTION Other diagnostic radiopharmaceuticals for tumour detection |
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 | AAA USA 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| N/A | LOCAMETZ | AAA USA NOVARTIS | N215841 | March 23, 2022 | RX | POWDER | INTRAVENOUS | March 23, 2025 | NEW PRODUCT |
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 |
| CHEMBL5095039 | ChEMBL_ID |
| 154572876 | PUBCHEM_CID |
| DB16019 | DRUGBANK_ID |
| 018581 | NDDF |
| 018925 | NDDF |
| CHEMBL3578202 | ChEMBL_ID |
| 1366302-52-4 | SECONDARY_CAS_RN |
| 2586016 | RXNORM |
| 349518 | MMSL |
| 357934 | MMSL |
| 37773 | MMSL |
| 40565 | MMSL |
| d09454 | MMSL |
| d09871 | MMSL |
| 9AG41L3AOQ | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LOCAMETZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69488-017 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 ug | INTRAVENOUS | NDA | 27 sections |
| LOCAMETZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69488-017 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 ug | INTRAVENOUS | NDA | 27 sections |