Drugs / 18F-DOPA

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FLUORODOPA F18 2019-10-10 fda.gov

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT02020720 Jan 2014 → Oct 2019 brain neoplasm, malignant glioma Mayo Clinic Completed No outcome recorded
Phase 0 NCT01165632 Jul 2010 → Nov 2013 adult anaplastic ependymoma, adult brainstem glioma, adult glioblastoma, adult oligodendroglioma +9 Mayo Clinic Completed No outcome recorded
Phase 12 trials
Phase 1 NCT04246437 Feb 2020 → Feb 2027 expected Lewy body dementia, Parkinson disease, pure autonomic failure Daniel Claassen Recruiting No outcome recorded
Phase 1 NCT02021604 Oct 2013 → Jan 2028 expected congenital isolated hyperinsulinism, pancreatic insulinoma Cook Children's Health Care System Recruiting No outcome recorded
Phase 28 trials
Phase 2 NCT06667726 Mar 2026 → May 2028 expected brain cancer Mayo Clinic Recruiting No outcome recorded
Phase 2 NCT07542158 May 2025 → Jun 2030 expected glioma, neuroendocrine neoplasm, parkinsonian disorder Akiva Mintz Enrolling by invitation No outcome recorded
Phase 2 NCT05088798 Sep 2020 → Jan 2030 expected hyperinsulinism Washington University School of Medicine Recruiting No outcome recorded
Phase 2 NCT03242824 Sep 2017 → Jun 2020 glioma Mayo Clinic Completed No outcome recorded
Phase 2 NCT02019706 Feb 2014 → Dec 2030 expected ectopic Cushing syndrome National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Recruiting No outcome recorded
Phase 2 NCT01468454 Jan 2009 → Jun 2014 congenital isolated hyperinsulinism Children's Hospital of Philadelphia Completed No outcome recorded
Phase 2 NCT00001849 May 1999 → Apr 2019 ectopic Cushing syndrome Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Completed No outcome recorded
Phase 2 NCT00001277 Dec 1993 → Mar 2020 hypercalcemia disease, multiple endocrine neoplasia type 1 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 34 trials
Phase 3 NCT05512403 Jun 2023 → Dec 2025 overdue glioma Central Hospital, Nancy, France Recruiting No outcome recorded
Phase 3 NCT03998852 Apr 2021 → Apr 2027 expected University Hospital, Bordeaux Recruiting No outcome recorded
Phase 3 NCT04706910 Jan 2021 → Dec 2027 expected Lewy body dementia, Parkinson disease, brain neoplasm, congenital isolated hyperinsulinism +2 University of Alberta Recruiting No outcome recorded
Phase 3 NCT03042416 Jun 2017 → Mar 2021 Parkinson disease, brain glioma, congenital isolated hyperinsulinism, neuroblastoma +1 University of Alberta Completed No outcome recorded
Phase not applicable2 trials
NCT03973502 Jun 2017 → May 2023 Parkinson disease, hepatitis B virus infection, hepatitis C virus infection National Taiwan University Hospital Unknown No outcome recorded
NCT02175745 Dec 2014 → Aug 2015 adult anaplastic ependymoma, adult brainstem glioma, adult glioblastoma, adult oligodendroglioma +17 Erik Mittra Terminated No outcome recorded
Phase not stated1 trial
NCT02533219 congenital isolated hyperinsulinism Baylor College of Medicine No longer available No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03581305 Comparator Nov 2018 → Apr 2022 AIDS dementia complex, HIV infectious disease, depressive disorder National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05781321 Background Mar 2023 → Jul 2026 overdue glioblastoma Mayo Clinic Active not recruiting No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as 18F-DOPA “Fortunately, \[18F\]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia.” NCT02533219
8

“6-\[18F\]-Fluoro-L-3,4,-dihydroxyphenylalanine (18F-DOPA)positron emission tomography (PET)” NCT05088798

“1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPANCT01468454

NCT04706910

NCT00001277

NCT03042416

NCT01468454

NCT02019706

NCT00001849

Known as 18-Fluoro-DOPA “For diagnostic failure, selective utilization of 18-Fluoro-DOPA PET/CT scanning, arterial stimulation/venous sampling, or transhepatic portal venous sampling were successful in...” PMID 24314196 Dec 2013
Known as 18-labeled L-fluorodeoxyphenylalanine “radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA)” NCT01468454
Known as 18F-FDOPA “One hour later all patient will be injected intravenously with 185 MBq (5mCi) 18F-FDOPA.” NCT03973502
5

“2 MBq / kg of 18F-FDOPANCT05512403

NCT07542158

NCT04246437

NCT03581305

NCT03998852

Known as 18F-Fluoro Dopa ClinicalTrials.gov intervention name — accepted as the source's own label NCT05088798
Known as 18F-fluoro-dihydroxyphenylalanine ClinicalTrials.gov intervention name — accepted as the source's own label NCT02175745
Known as 6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine “6-\[18F\]-Fluoro-L-3,4,-dihydroxyphenylalanine (18F-DOPA)positron emission tomography (PET)” NCT05088798
Known as 6-[18F]fluorolevodopa (U.S. Pharmacopeia) 6-[18F]fluorolevodopa (U.S. Pharmacopeia)NCT02021604
Known as F-DOPA “radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA)” NCT01468454
Known as Fluorine F 18 Fluorodopa ClinicalTrials.gov intervention name — accepted as the source's own label NCT03242824
2

NCT02020720

NCT01165632

Known as Fluorodopa 18F (International Non-Proprietary Name) Fluorodopa 18F (International Non-Proprietary Name)NCT02021604
Known as Fluorodopa F 18 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05781321
2

NCT06667726

NCT02021604

Known as Fluorodopa F 18 (CAS Number 75290-51-6) Fluorodopa F 18 (CAS Number 75290-51-6)NCT02021604
Modality Diagnostic / imaging agent “Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA” NCT00001277
Route Intravenous “Given IV” NCT01165632