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PET/CT with 18F-DOPA
PET/CT with 18F-DOPA is a PET imaging agent Small molecule drug developed by Central Hospital, Nancy, France. It is currently in Phase 3 development for Parkinson's disease and parkinsonian syndromes (differential diagnosis), Neuroendocrine tumors (carcinoid, pheochromocytoma), Movement disorders with suspected dopaminergic dysfunction.
18F-DOPA is a positron emission tomography (PET) tracer that accumulates in dopamine-producing tissues, allowing visualization and quantification of dopaminergic function in the brain.
PET/CT with 18F-DOPA is a medical imaging technique used to study various conditions, including Parkinson's disease, brain metastases, radiation necrosis, neuroendocrine tumors, and glioma. This technique involves the use of a protein-targeting modality, specifically [18F]-DOPA, which binds to proteins in the body, allowing for the visualization of certain conditions through PET-CT imaging.
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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 | PET/CT with 18F-DOPA |
|---|---|
| Sponsor | Central Hospital, Nancy, France |
| Drug class | PET imaging agent |
| Target | Dopaminergic neurons; aromatic amino acid decarboxylase |
| Modality | Small molecule |
| Therapeutic area | Neurology; Oncology (neuroendocrine tumors) |
| Phase | Phase 3 |
Mechanism of action
18F-DOPA (fluorine-18 L-DOPA) is a radiolabeled amino acid precursor of dopamine that crosses the blood-brain barrier and is taken up by dopaminergic neurons via the large neutral amino acid transporter. Once internalized, it is converted to 18F-dopamine by aromatic amino acid decarboxylase, allowing PET/CT imaging to detect and measure dopaminergic neuron integrity and function. This enables diagnostic assessment of conditions affecting the nigrostriatal dopaminergic system.
Approved indications
- Parkinson's disease and parkinsonian syndromes (differential diagnosis)
- Neuroendocrine tumors (carcinoid, pheochromocytoma)
- Movement disorders with suspected dopaminergic dysfunction
Common side effects
- Radiation exposure
- Allergic reaction to tracer
Key clinical trials
- Diagnosis of Pheochromocytoma (PHASE1)
- Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study (PHASE2)
- Evaluation of the Predictive Value of 18F-fluorodeoxyglucose Positron Emission Tomography and Brain Perfusion Computed Tomography for the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Recurrent Glioblastoma (NA)
- Dynamic F-DOPA PET for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis (NA)
- Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (NA)
- Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors (PHASE2)
- Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma (EARLY_PHASE1)
- 18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy (PHASE2)
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:
- PET/CT with 18F-DOPA CI brief — competitive landscape report
- PET/CT with 18F-DOPA updates RSS · CI watch RSS
- Central Hospital, Nancy, France portfolio CI
Frequently asked questions about PET/CT with 18F-DOPA
What is PET/CT with 18F-DOPA?
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What is PET/CT with 18F-DOPA used for?
Who makes PET/CT with 18F-DOPA?
What drug class is PET/CT with 18F-DOPA in?
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Related
- Drug class: All PET imaging agent drugs
- Target: All drugs targeting Dopaminergic neurons; aromatic amino acid decarboxylase
- Manufacturer: Central Hospital, Nancy, France — full pipeline
- Therapeutic area: All drugs in Neurology; Oncology (neuroendocrine tumors)
- Indication: Drugs for Parkinson's disease and parkinsonian syndromes (differential diagnosis)
- Indication: Drugs for Neuroendocrine tumors (carcinoid, pheochromocytoma)
- Indication: Drugs for Movement disorders with suspected dopaminergic dysfunction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing