Drugs / 18F-fluciclovine
18F-fluciclovine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Axumin | — | 2017-05-21 | europa.eu ↗ |
| Approved | US (FDA) | AXUMIN | — | 2016-05-27 | fda.gov ↗ |
Trials 42 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 09 trials | ||||||
| Phase 0 | NCT05555550 | Jul → Dec 2026 expected | brain glioma, low grade glioma | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 0 | NCT06613841 | May 2025 → Oct 2026 expected | brain glioblastoma | Abramson Cancer Center at Penn Medicine | Recruiting | No outcome recorded |
| Phase 0 | NCT05553041 | Aug 2024 → Dec 2026 expected | brain glioma | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 0 | NCT04852523 | Sep 2021 → Oct 2022 | disease related to solid organ transplantation, pancreatitis | University of Utah | Completed | No outcome recorded |
| Phase 0 | NCT04018053 | Feb 2020 → Jun 2024 | urinary bladder cancer, urothelial carcinoma | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 0 | NCT04114370 | Oct 2019 → May 2021 | glioma | James Mountz | Completed | No outcome recorded |
| Phase 0 | NCT03930173 | Jul 2019 → Mar 2021 | metastatic malignant neoplasm in the brain | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 0 | NCT01933269 | May 2015 → Feb 2018 | head and neck cancer | Emory University | Withdrawn | No outcome recorded |
| Phase 0 | NCT01864083 | May 2013 → Aug 2017 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT06048094 | Apr 2024 → Jun 2032 expected | metastatic malignant neoplasm in the brain | Baptist Health South Florida | Recruiting | No outcome recorded |
| Phase 1 | NCT06062745 | Feb 2024 → Sep 2026 expected | metastatic prostate carcinoma, prostate neuroendocrine neoplasm | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT04689048 | Apr 2022 → Mar 2027 expected | metastatic malignant neoplasm in the brain | Baptist Health South Florida | Recruiting | No outcome recorded |
| Phase 1 | NCT04750473 | Jul 2021 → Mar 2023 | female breast carcinoma, invasive lobular breast carcinoma | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT03990285 | Jun 2019 → Nov 2021 | glioblastoma | Ali Nabavizadeh | Completed | No outcome recorded |
| Phase 1 | NCT01502670 | May 2009 → Jun 2012 | lung cancer | Emory University | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03276676 | Sep 2018 → Apr 2021 | brain neoplasm | University of Utah | Terminated | No outcome recorded |
| Phase 1/2 | NCT03264456 | Nov 2017 → Jan 2019 | prostate cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT06103838 | Mar 2024 → Dec 2027 expected | plasma cell myeloma, refractory plasma cell neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05554302 | Jan 2023 → Jan 2030 expected | metastatic malignant neoplasm in the brain | Baptist Health South Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT04410367 | Aug 2020 → Dec 2021 | metastatic malignant neoplasm in the brain | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 2 | NCT03925675 | Aug 2020 → Aug 2023 | brain neoplasm | Loma Linda University | Withdrawn | No outcome recorded |
| Phase 2 | NCT04158245 | Jan 2020 → Sep 2022 | prostate carcinoma | Tulane University | Completed | No outcome recorded |
| Phase 2 | NCT03762759 | May 2019 → May 2025 overdue | prostate adenocarcinoma | Emory University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03515577 | Apr 2019 | prostate carcinoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03707184 | Oct 2018 → Feb 2022 | metastatic carcinoma in the bone, metastatic prostate carcinoma | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT03373006 | Feb 2018 → Jan 2020 | prostate cancer | HALO Diagnostics | Completed | No outcome recorded |
| Phase 2 | NCT03263780 | Dec 2017 → Jan 2020 | prostate cancer | Timothy J. Daskivich | Completed | No outcome recorded |
| Phase 2 | NCT03081884 | Mar 2017 → Dec 2019 | cancer | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT02830880 | Jul 2016 → Dec 2018 | prostate cancer | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT02744534 | Nov 2015 → Mar 2018 | prostate cancer | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT01808222 | Nov 2013 → Sep 2017 | prostate carcinoma | David M. Schuster, MD | Completed | No outcome recorded |
| Phase 2 | NCT01176513 | Jul 2010 → Mar 2012 | prostate cancer | GE Healthcare | Terminated | No outcome recorded |
| Phase 2 | NCT00562315 | Oct 2007 → Jul 2015 | prostate cancer | David M. Schuster, MD | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01666808 | Sep 2012 → Apr 2022 | prostate cancer | Emory University | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04410133 | Oct 2020 → Jun 2023 | metastatic malignant neoplasm in the brain | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 3 | NCT02680041 | Jun 2016 → Nov 2017 | prostate cancer | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 3 | NCT02578940 | Nov 2015 → May 2017 | prostate cancer | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07569926 | Jun 2026 → Dec 2027 expected | prostate cancer | Blue Earth Diagnostics | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04134208 | Sep 2019 → Jun 2022 | metastatic prostate carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 4 | NCT03423082 | Dec 2018 → Dec 2019 | cervical cancer | Nghi Nguyen | Terminated | No outcome recorded |
| Phase 4 | NCT03349463 | Nov 2018 → Dec 2020 | cervical cancer, endometrial cancer, malignant epithelial tumor of ovary | Bital Savir-Baruch | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00597246 | May 2003 → Nov 2019 | brain cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-fluciclovine | “The purpose of this study was to assess the potential use of 18F-fluciclovine PET/MRI for initial staging of high-risk prostate cancer and evaluating response to androgen...” PMID 33052718 ↗ Oct 202023“18F-Fluciclovine is a fluorine-18 labeled synthetic amino acid analog that is FDA approved as a PET imaging agent for prostate cancer recurrence, however, it has also been...” NCT03990285 ↗ “18F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (18F-fluciclovine) is a leucine analog radiotracer that depicts amino acid transport into cells.” PMID 27856630 ↗ Nov 2016 “The radiochemical purity of 18F-fluciclovine injection is not less than 95% during the shelf life of the product.” NCT03373006 ↗ |
| Known as | 18F-Axumin | “Although 18F-Axumin™ is an FDA approved PET imaging agent for biological recurrent prostate cancer with extensive safety and toxicity data already documented, all patients will...” NCT03925675 ↗ |
| Known as | 18F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid | “18F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (18F-fluciclovine) is a leucine analog radiotracer that depicts amino acid transport into cells.” PMID 27856630 ↗ Nov 2016 |
| Known as | 18F-labeled fluciclovine | “CONCLUSION.18F-labeled fluciclovine PET/MRI shows potential utility in initial staging of high-risk prostate cancer and in evaluating response to ADT.” PMID 33052718 ↗ Oct 2020 |
| Known as | anti-1-amino-3-\[18F\]fluorocyclobutane-1- carboxylic acid | “Prior studies have shown that Positron Emission Tomography (PET)/Computed Tomography (CT) imaging with the PET molecular imaging agent, a synthetic amino acid,...” NCT02744534 ↗1“Anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F]FACBC) is a synthetic amino acid positron emission tomography (PET) radiotracer” PMID 23595643 ↗ Oct 2013 |
| Known as | Anti-3-[(18)F]FACBC | “Anti-3-[(18)F]FACBC is a synthetic amino acid positron emission tomography (PET) radiotracer with utility in detection of prostate carcinoma and brain tumors and has also been...” PMID 23595643 ↗ Oct 2013 |
| Known as | Axumin | “the on-line Axumin™ (fluciclovine F 18) Image Interpretation Training” NCT03373006 ↗ |
| Known as | F-18 fluciclovine | “using the amino acid PET tracer, F-18 fluciclovine.” NCT03264456 ↗ |
| Known as | FACBC | “Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma” NCT04114370 ↗ |
| Known as | fluciclovine | “using the amino acid PET tracer, F-18 fluciclovine.” NCT03264456 ↗ |
| Known as | fluciclovine (18F) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07569926 ↗ |
| Known as | Fluciclovine F18 | “Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate...” NCT03373006 ↗8“investigational agent Axumin (fluciclovine-F18) with PET/CT imaging” NCT03925675 ↗ |
| Known as | GE-148 (18F) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01176513 ↗ |
| Modality | Diagnostic / imaging agent | “positron emission tomography (PET) radiotracer” NCT00562315 ↗ |
| Route | Intravenous | “given intravenously prior to PET scan” NCT00562315 ↗ |