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[18F]-Choline (FLUOROMETHYLCHOLINE (18F))
[18F]-Choline (generic name: FLUOROMETHYLCHOLINE (18F)) is a fluoromethylcholine (18F) drug. It is currently in Phase 3 development.
18F-Choline works by being taken up by cancer cells, where it is then visualized using positron emission tomography (PET) imaging.
18F-Choline, also known as Fluoromethylcholine (18F), is a small molecule radiopharmaceutical developed for diagnostic imaging purposes. Its exact target is unknown, but it is used to visualize certain types of cancer, particularly prostate cancer. The commercial status of 18F-Choline is unclear, and it is not approved by the FDA for any indications. Further research is needed to determine its safety and efficacy. As a radiopharmaceutical, it is not intended for therapeutic use.
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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 | FLUOROMETHYLCHOLINE (18F) |
|---|---|
| Drug class | fluoromethylcholine (18F) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Imagine your body is a city, and cancer cells are like buildings that are being repaired. 18F-Choline is like a special dye that is taken up by the repair crews (cancer cells), making them visible to the imaging machine. This allows doctors to see where the cancer is and how it's growing.
Approved indications
Common side effects
Key clinical trials
- Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors (PHASE2,PHASE3)
- Expanded Access:18F-Fluorocholine for the Detection of Parathyroid Adenomas
- 99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT (PHASE2,PHASE3)
- 18F-choline Positron-emission-tomography - Computed-tomography Compared to Conventional Imaging for Localizing Diseased Parathyroid Glands in Primary Hyperparathyroidism (NA)
- Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma (PHASE3)
- Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma (PHASE2)
- High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins (NA)
- Clinical Application of the J-PET Scanner Prototype
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:
- [18F]-Choline CI brief — competitive landscape report
- [18F]-Choline updates RSS · CI watch RSS
Frequently asked questions about [18F]-Choline
What is [18F]-Choline?
How does [18F]-Choline work?
What is the generic name of [18F]-Choline?
What drug class is [18F]-Choline in?
What development phase is [18F]-Choline in?
Related
- Drug class: All fluoromethylcholine (18F) drugs
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing