Used in scans for suspected Parkinsonian syndromes (PS). Sold as Fluorodopa F18. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Fluorodopa F-18 (sold as Fluorodopa F18), first approved Oct 10, 2019, with 0 new uses approved and 2 published complete response letters.
| Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 TrialGlioblastoma, IDH-Wildtype · Mayo Clinic | Phase 3 | Not yet recruiting | Nov 13, 2026 |
| Ultralow Dose PET Imaging of 18F-FDOPAHeathy Volunteer, Parkinsonian Syndromes · Akiva Mintz | Phase 2 | Enrolling by invitation | Apr 21, 2026 |
| An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain TumorsMalignant Brain Neoplasm · Mayo Clinic | Phase 2 | Recruiting | Oct 31, 2024 |
| Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive TimeHealthy Aging · Institut National de la Santé Et de la Recherche Médicale, France | — | Recruiting | Apr 5, 2024 |
| Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA StudyGlioblastoma · Mayo Clinic | Phase 2 | Active, not recruiting | Mar 23, 2023 |
| Utility of 18FDOPA PET/MRI for Focal HyperinsulinismHyperinsulinism · Washington University School of Medicine | Phase 2 | Recruiting | Oct 22, 2021 |
| 18F-DOPA II - PET Imaging OptimizationCongenital Hyperinsulinism, Neuroblastoma · University of Alberta | Phase 3 | Recruiting | Jan 13, 2021 |
| FDOPA PET and Nutritional Support in Parkinson's DiseaseParkinson Disease, Idiopathic Parkinson Disease · Thomas Jefferson University | Phase 2 | Active, not recruiting | Jul 7, 2020 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Oct 10, 2019 | Fluorodopa F18NDA 200655 · New molecular entity | Feinstein | 1 | Marketed |
| Sep 15, 2016 | Fluorodopa F 18Clinical / Statistical | Approved |
| Oct 22, 2013 | Fluorodopa F 18Clinical / Statistical, Good Clinical Practice (Gcp) Inspection, Product Quality | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
