fluoroestradiol F 18 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5395 | 94153-53-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Fluoroestradiol F 18 binds ER and it is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging. The following binding affinity: Kd = 0.13 ± 0.02 nM, Bmax = 1901 ± 89 fmol/mg, and IC50 = 0.085 nM, was determined in an ER-positive human breast cancer cell line (MCF-7). Fluoroestradiol F 18 is indicated for characterization of estrogen receptor status of known or suspected metastatic lesions in patients with confirmed ER-positive breast cancer.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 20, 2020 | FDA | ZIONEXA |
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 | V09IX11 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS TUMOUR DETECTION Other diagnostic radiopharmaceuticals for tumour detection |
| FDA MoA | N0000175869 | Positron Emitting Activity |
| FDA EPC | N0000177914 | Radioactive Diagnostic Agent |
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)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 50ML (4-100mCi/ML) | CERIANNA | ZIONEXA | N212155 | May 20, 2020 | RX | SOLUTION | INTRAVENOUS | May 20, 2025 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Estrogen receptor | Nuclear hormone receptor | BINDING AGENT | IC50 | 10.07 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| D11829 | KEGG_DRUG |
| T32277KB09 | UNII |
| 92817-10-2 | SECONDARY_CAS_RN |
| C1831937 | UMLSCUI |
| CHEMBL4594261 | ChEMBL_ID |
| 10869981 | PUBCHEM_CID |
| DB15690 | DRUGBANK_ID |
| CHEMBL1627367 | ChEMBL_ID |
| 018375 | NDDF |
| 926372005 | SNOMEDCT_US |
| 926373000 | SNOMEDCT_US |
| 2372221 | RXNORM |
| 363734 | MMSL |
| 41114 | MMSL |
| d09952 | MMSL |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| CERIANNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72874-001 | INJECTION | 100 mCi | INTRAVENOUS | NDA | 17 sections |
| CERIANNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72874-001 | INJECTION | 100 mCi | INTRAVENOUS | NDA | 17 sections |
| CERIANNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72874-001 | INJECTION | 100 mCi | INTRAVENOUS | NDA | 17 sections |
| CERIANNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72874-001 | INJECTION | 100 mCi | INTRAVENOUS | NDA | 17 sections |