FLUDEOXYGLUCOSE F18 (fludeoxyglucose f-18)
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.
Development Insights
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
FLUDEOXYGLUCOSE F18 Competitive Set
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Indication competitors
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What's emerging in FLUDEOXYGLUCOSE F18's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FLUDEOXYGLUCOSE F18 treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01507428 results posted | NCI-2012-00107 NCI-2012-00107, CDR0000721619 | Ph 2 | completed | Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer |
| NCT04692103 results posted | RG1007834 10465 | Ph 2 | active not recruiting | Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy |
| NCT03432741 | MC1689 NCI-2018-00149, MC1689 | Ph 1 | terminated | Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer |
| NCT03824535 results posted | IRB-46607 NCI-2019-00177, LUN0106 | Ph 2 | completed | 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules |
| NCT03493789 | IRB00101066 NCI-2018-00375, RAD4267-17 | Ph 1 | completed | Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy |
| NCT02429804 | PROS0063 NCI-2015-00553, ep 32653 | Ph 1 | terminated | NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer |
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
Indications & Usage
FDA Label (PDF)FLUDEOXYGLUCOSE F18 is indicated for the treatment of 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment