CHOLINE C-11
Choline C-11 is a radioactive diagnostic agent used for PET imaging in patients who may have returning prostate cancer. It helps patients with rising PSA levels after their initial treatment when standard scans like CT, MRI, or bone scintigraphy fail to provide clear information. This imaging helps clinicians identify specific locations where the cancer might be recurring so they can proceed with tissue samples for confirmation.
How CHOLINE C-11 Works
This agent works by acting as a radiolabeled version of choline, a molecule essential for building cell membranes. Since rapidly dividing tumor cells require more membrane components, they take up higher amounts of choline than healthy tissue. This concentration of the radioactive tracer allows the PET scan to visualize areas of potential cancer growth.
Details
- Status
- Prescription
- First Approved
- 2012-09-12
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
CHOLINE C-11 Approval History
What CHOLINE C-11 Treats
1 indicationsCHOLINE C-11 is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
CHOLINE C-11 Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CHOLINE C-11's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CHOLINE C-11 treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Key Completed Trials
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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.
CHOLINE C-11 FDA Label Details
Indications & Usage
FDA Label (PDF)CHOLINE C-11 is indicated for the treatment of Prostate Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.