flotufolastat f-18 gallium 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| inhibitors of folate hydrolase 1 (prostate-specific membrane antigen, PSMA); enzymes inhibitors | 5732 | 2305081-64-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
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Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA. Fluorine-18 is a beta+ emitting radionuclide that can be detected using positron emission tomography.
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Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 25, 2023 | FDA | BLUE EARTH |
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:
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 50ML (8-158mCi/ML) | POSLUMA | BLUE EARTH | N216023 | May 25, 2023 | RX | SOLUTION | INTRAVENOUS | 11413360 | Nov. 22, 2038 | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER WITH SUSPECTED METASTASIS WHO ARE CANDIDATES FOR INITIAL DEFINITIVE THERAPY |
| 50ML (8-158mCi/ML) | POSLUMA | BLUE EARTH | N216023 | May 25, 2023 | RX | SOLUTION | INTRAVENOUS | 11413360 | Nov. 22, 2038 | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER WITH SUSPECTED RECURRENCE BASED ON ELEVATED SERUM PROSTATE-SPECIFIC ANTIGEN (PSA) LEVEL |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 50ML (8-158mCi/ML) | POSLUMA | BLUE EARTH | N216023 | May 25, 2023 | RX | SOLUTION | INTRAVENOUS | May 25, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glutamate carboxypeptidase 2 | Enzyme | BINDING AGENT | IC50 | 8.36 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 019456 | NDDF |
| 166177191 | PUBCHEM_CID |
| D12606 | KEGG_DRUG |
| XD423NK2WO | UNII |
Pharmaceutical products:
None