FLUDEOXYGLUCOSE F18
Fludeoxyglucose F18 is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in oncology, cardiology, and neurology. In oncology, it is used to assess abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities or an existing cancer diagnosis. In cardiology, it is used to identify left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. In neurology, it is indicated to identify regions of abnormal glucose metabolism associated with foci of epileptic seizures. IMPROVED_HOW_IT_WORKS: Fludeoxyglucose F18 is a glucose analog transported into cells by facilitative glucose transporter proteins and phosphorylated by hexokinase into [18F] FDG-6-phosphate. Once phosphorylated, the agent is trapped within the cell as it cannot exit until it is dephosphorylated by glucose-6-phosphatase. Its retention reflects the balance of glucose transporter, hexokinase, and glucose-6-phosphatase activities. By comparing uptake levels to background tissue, the agent allows for the assessment of glucose metabolism; regions of increased uptake reflect higher than normal metabolic rates, while regions of decreased or absent uptake reflect a decrease or absence of glucose metabolism.
How FLUDEOXYGLUCOSE F18 Works
Fludeoxyglucose F18 is a glucose analog that is transported into cells by facilitative glucose transporter proteins and phosphorylated by the enzyme hexokinase into [18F] FDG-6-phosphate. Once phosphorylated, the agent is trapped within the cell, where its retention reflects the balance of glucose transporter, hexokinase, and glucose-6-phosphatase activities. By comparing uptake levels to background tissue, the agent allows for the assessment of glucose metabolism, with increased uptake indicating higher than normal metabolic rates.
Details
- Status
- Prescription
- First Approved
- 1994-08-19
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- INJECTABLE
Companies
FLUDEOXYGLUCOSE F18 Approval History
What FLUDEOXYGLUCOSE F18 Treats
3 indicationsFLUDEOXYGLUCOSE F18 is approved for 3 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Evaluation of malignancy in patients with known or suspected abnormalities or an existing diagnosis of cancer
- Identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function
- Identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLUDEOXYGLUCOSE F18 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.