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F-18-Fluorocholine
F-18-Fluorocholine is a PET imaging agent Small molecule drug developed by ABX advanced biochemical compounds GmbH. It is currently in Phase 3 development for PET imaging of prostate cancer, PET imaging of brain tumors, PET imaging of other malignancies with elevated choline metabolism.
F-18-Fluorocholine is a positron emission tomography (PET) imaging agent that accumulates in cells with high choline metabolism, enabling visualization of metabolically active tissues.
F-18-Fluorocholine is a positron emission tomography (PET) imaging agent that accumulates in cells with high choline metabolism, enabling visualization of metabolically active tissues. Used for PET imaging of prostate cancer, PET imaging of brain tumors, PET imaging of other malignancies with elevated choline metabolism.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | F-18-Fluorocholine |
|---|---|
| Sponsor | ABX advanced biochemical compounds GmbH |
| Drug class | PET imaging agent |
| Target | Choline transporters; Choline kinase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
F-18-Fluorocholine is a fluorine-18 labeled choline analog used as a PET tracer. It exploits the increased choline uptake and metabolism in malignant cells compared to normal tissue, allowing detection and localization of tumors. The agent crosses cell membranes via choline transporters and is incorporated into phosphatidylcholine, making it useful for imaging various cancers with elevated choline kinase activity.
Approved indications
- PET imaging of prostate cancer
- PET imaging of brain tumors
- PET imaging of other malignancies with elevated choline metabolism
Common side effects
- Radiation exposure (inherent to PET imaging)
Key clinical trials
- FCH PET/MRI Parathyroid Localization (NA)
- Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC (NA)
- Molecular Imaging of Plaque Vulnerability (PHASE3)
- FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM) (NA)
- Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention (PHASE3)
- Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography (PHASE1)
- F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
- F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- F-18-Fluorocholine CI brief — competitive landscape report
- F-18-Fluorocholine updates RSS · CI watch RSS
- ABX advanced biochemical compounds GmbH portfolio CI
Frequently asked questions about F-18-Fluorocholine
What is F-18-Fluorocholine?
How does F-18-Fluorocholine work?
What is F-18-Fluorocholine used for?
Who makes F-18-Fluorocholine?
What drug class is F-18-Fluorocholine in?
What development phase is F-18-Fluorocholine in?
What are the side effects of F-18-Fluorocholine?
What does F-18-Fluorocholine target?
Related
- Drug class: All PET imaging agent drugs
- Target: All drugs targeting Choline transporters; Choline kinase
- Manufacturer: ABX advanced biochemical compounds GmbH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for PET imaging of prostate cancer
- Indication: Drugs for PET imaging of brain tumors
- Indication: Drugs for PET imaging of other malignancies with elevated choline metabolism
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing