Drugs / 18F-fluciclovine
18F-fluciclovine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed low grade glioma 1 milestone | |||||
| Filed | US (FDA) | Axumin | low grade glioma | 2018-12-10 | “FDA) has accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin® (fluciclovine F 18) in adults” blueearthdiagnostics.com ↗ “FDA Filing Acceptance of Supplemental New Drug Application (sNDA) for 18F‐fluciclovine PET Imaging in Glioma” blueearthdiagnostics.com ↗ |
| Filed prostate cancer, hereditary, X-linked 3 2 milestones | |||||
| Filed | EU (EMA) | — | prostate cancer, hereditary, X-linked 3 | 2016-03-24 | “BED has submitted an application to the European Medicines Agency (EMA) for an EU/EEA marketing authorisation for fluciclovine (18F) for lesion detection and localisation for...” blueearthdiagnostics.com ↗ |
| Filed | US (FDA) | — | prostate cancer, hereditary, X-linked 3 | 2015-12-02 | “BLUE EARTH DIAGNOSTICS AND SIEMENS’ PETNET SOLUTIONS ANNOUNCE FDA ACCEPTANCE OF NDA FILING FOR FLUCICLOVINE” blueearthdiagnostics.com ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 07 trials | ||||||
| Phase 0 | NCT05555550 | Nov 2026 → Dec 2027 expected | brain glioma, low grade glioma | Children's Hospital of Philadelphia | 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 | NCT01864083 | May 2013 → Aug 2017 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 13 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 overdue | 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 1/22 trials | ||||||
| Phase 1/2 | NCT03276676 | Sep 2018 → Apr 2021 | brain neoplasm | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03264456 | Nov 2017 → Jan 2019 | prostate cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| 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 | NCT04158245 | Jan 2020 → Sep 2022 | prostate carcinoma | Tulane University | Completed | No outcome recorded |
| Phase 2 | NCT03263780 | Dec 2017 → Jan 2020 | prostate cancer | Timothy J. Daskivich | Completed | Missed primary |
| 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 41 trial | ||||||
| Phase 4 | NCT03423082 | Dec 2018 → Dec 2019 | cervical cancer | Nghi Nguyen | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | Blue Earth Diagnostics | Results Blue Earth Diagnostics to Present New Molecular Imaging Data Advancing Patient Outcomes at the Society of Nuclear Medicine and Molecular Imaging 2026 Annual Meeting blueearthdiagnostics.com ↗
Additional data from a prospective clinical study underscores the potential utility of Axumin® (fluciclovine F 18) in patients with negative or inconclusive PSMA PET scans, supporting continued innovation in prostate cancer imaging. |
| 2022-07-19 | Blue Earth Diagnostics | Results Independent Clinical Studies Published Regarding Performance of Axumin® (Fluciclovine F 18) PET Imaging in Patients with Recurrent Prostate Cancer Undergoing Androgen Deprivation Therapy (ADT) blueearthdiagnostics.com ↗ |
| 2021-09-27 | Blue Earth Diagnostics | Results Blue Earth Diagnostics Announces Results of an Analysis of the Impact of Axumin® (Fluciclovine F 18) PET/CT Imaging on Androgen Deprivation Therapy (ADT) Planning in Recurrent Prostate Cancer blueearthdiagnostics.com ↗ |
| 2021-05-25 | Blue Earth Diagnostics | Results The Lancet Publishes Results of Axumin® (Fluciclovine F 18) PET Imaging Study Demonstrating Improved Patient Outcomes in Patients with Recurrent Prostate Cancer blueearthdiagnostics.com ↗
The randomized, prospective study showed that Axumin-guided post-prostatectomy radiation therapy increased biochemical event-free survival rates in men with recurrent disease. |
| 2019-09-16 | Blue Earth Diagnostics | Results Results from Blue Earth Diagnostics’ FALCON Trial Show 64% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Following Axumin® (Fluciclovine F 18) PET/CT Scan blueearthdiagnostics.com ↗
Results of the trial indicated that 64% (66/104) of patients had their clinical management plan changed when results of 18F-fluciclovine PET/CT imaging were added to the standard-of-care diagnostic work-up. |
| 2019-06-26 | Blue Earth Diagnostics | Results Blue Earth Diagnostics Announces Results from Investigational Clinical Study of Safety and Effectiveness of 18F-Fluciclovine PET Imaging in Adult Glioma blueearthdiagnostics.com ↗
Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced results from a retrospective, observational analysis evaluating the safety and effectiveness of 18F-fluciclovine in the detection of recurrent gliomas in adults, using data from multiple research sites. |
| 2019-05-06 | Blue Earth Diagnostics | Results Blue Earth Diagnostics Announces Results of Additional Analyses from LOCATE Trial Evaluating Change in Recurrent Prostate Cancer Management Following Axumin® (Fluciclovine F 18) PET/CT Imaging blueearthdiagnostics.com ↗
Results indicated that patient level and pelvic region detection rates were broadly proportional to baseline PSA, with clinically important detection noted in pelvic nodes (9.3%), retroperitoneal nodes (5.6%) and bone (6.5%). |
| 2018-12-10 | Blue Earth Diagnostics | Regulatory Blue Earth Diagnostics Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of Supplemental New Drug Application (sNDA) for 18F-fluciclovine PET Imaging in Glioma blueearthdiagnostics.com ↗ |
| 2018-11-19 | Blue Earth Diagnostics | Results Blue Earth Diagnostics Announces Results of Investigational Phase 3 Blinded Image Evaluation Study of 18F-Fluciclovine PET Imaging in Glioma blueearthdiagnostics.com ↗ |
| 2018-10-02 | Blue Earth Diagnostics | Regulatory Axumin® (fluciclovine (18F)) receives positive recommendation from Transparency Committee of the French HAS, for use in PET imaging of suspected recurrent prostate cancer blueearthdiagnostics.com ↗ |
| 2018-09-11 | Blue Earth Diagnostics | Results The Journal of Urology Publishes Results from Blue Earth Diagnostics’ LOCATE Trial of Role of 18F Fluciclovine PET/CT Imaging in the Management of Men with Recurrent Prostate Cancer blueearthdiagnostics.com ↗
Results show that 59% of men with recurrent prostate cancer following prior treatment had a change in their management plan after 18F fluciclovine PET/CT imaging |
| 2018-05-21 | Blue Earth Diagnostics | Results Results from Blue Earth Diagnostics’ LOCATE Trial Show 59% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Plan Following 18F Fluciclovine PET/CT Scan blueearthdiagnostics.com ↗
Results from Blue Earth Diagnostics’ LOCATE Trial Show 59% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Plan Following 18F Fluciclovine PET/CT Scan |
| 2017-05-23 | Blue Earth Diagnostics | Regulatory Blue Earth Diagnostics receives marketing authorisation for Axumin™ (Fluciclovine (18F)) for PET imaging of recurrent prostate cancer blueearthdiagnostics.com ↗
Axumin is the first and only PET imaging agent indicated for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. |
| 2017-05-12 | Blue Earth Diagnostics | Results Blue Earth Diagnostics’ FALCON Trial of Fluciclovine (18F) PET/CT Imaging in Recurrent Prostate Cancer Stops Recruitment after Successful Interim Analysis blueearthdiagnostics.com ↗
Blue Earth Diagnostics, a molecular imaging diagnostics company, announced that the Trial Steering Committee recommended that further recruitment be stopped in the FALCON clinical study of fluciclovine (18F) PET/CT imaging, based on successful results of a pre-planned interim analysis. |
| 2017-05-03 | Blue Earth Diagnostics | Results Blue Earth Diagnostics Announces Publication of Reader Training Study Results for AxuminTM (Fluciclovine F 18) PET Imaging of Men with Recurrent Prostate Cancer blueearthdiagnostics.com ↗
The manuscript, “Reader training for the re-staging of biochemically recurrent prostate cancer using fluciclovine (18F) PET/CT,” was accepted by The Journal of Nuclear Medicine and is now available online: J Nucl Med 2017; doi: 10.2967/jnumed.116.188375. |
| 2017-03-24 | Blue Earth Diagnostics | Regulatory Blue Earth Diagnostics receives positive CHMP opinion for Axumin™ (Fluciclovine (18F)) for PET imaging of recurrent prostate cancer blueearthdiagnostics.com ↗
Blue Earth Diagnostics receives positive CHMP opinion for Axumin™ (Fluciclovine (18F)) for PET imaging of recurrent prostate cancer |
| 2016-10-25 | Blue Earth Diagnostics | Results The Journal of Urology Publishes Blue Earth Diagnostics’ Phase 3 Study Results of AxuminTM (Fluciclovine F 18) for PET Imaging of Recurrent Prostate Cancer blueearthdiagnostics.com ↗
Blue Earth Diagnostics, Ltd. a molecular imaging diagnostics company, announced the peer-reviewed publication of results from a Phase 3 clinical trial of Axumin (fluciclovine F 18) injection. |
| 2016-06-10 | Nihon Medi-Physics Co., Ltd. | Regulatory 新規PET製剤が米国で承認される nmp.co.jp ↗
（英国、 オックスフォード 2016 年5 月 31 日）ブルー ・ アース ・ ダイアグノスティックス社 （Blue Earth Diagnostics Ltd. 本社：英国オックスフォード、CEO: Jonathan Allis氏、以下「BED」） が 、2016 年 5 月 27 日付で悪性腫瘍イメージング剤（有効成分：18F-fluciclovine、製品名：「Axumin」）について、米 国食品医薬品局（FDA）の承認を取得したと発表しました。 |
| 2016-06-03 | Blue Earth Diagnostics | Regulatory FDA approves new diagnostic imaging agent to detect recurrent prostate cancer blueearthdiagnostics.com ↗
The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. |
| 2016-06-03 | Blue Earth Diagnostics | Regulatory U.S. FDA Approves Blue Earth Diagnostics’ AxuminTM (Fluciclovine F 18) Injection after Priority Review for PET Imaging of Recurrent Prostate Cancer blueearthdiagnostics.com ↗
Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has approved Axumin (fluciclovine F 18) injection, a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment. |
| 2015-12-02 | Blue Earth Diagnostics | Regulatory Blue Earth Diagnostics and Siemens’ PETNET Solutions announce FDA acceptance of NDA filing for fluciclovine blueearthdiagnostics.com ↗ |
| 2015-07-08 | Blue Earth Diagnostics | Regulatory Blue Earth Diagnostics granted US and European orphan drug designation for fluciclovine (18F) in the diagnosis of glioma blueearthdiagnostics.com ↗
Blue Earth Diagnostics Ltd (“BED”), a private diagnostics company, announces today that it has received both U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Orphan Drug Designation (ODD) for fluciclovine (18F) in the diagnosis of glioma. |
All press releases naming this drug 65 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 22 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 202021“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 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 | Axumin | “18F-fluciclovine (Axumin®) PET imaging” NCT05553041 ↗ |
| 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 ↗ |
| Modality | Diagnostic / imaging agent | “is a leucine analog radiotracer that depicts amino acid transport into cells” PMID 27856630 ↗ Nov 2016 |
| Route | Intravenous | “Single intravenous administration of 18F-Fluciclovine for PET Scan” NCT02578940 ↗ |