Drugs / 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 | “Food and Drug Administration (FDA) Filing Acceptance of Supplemental New Drug Application (sNDA) for 18F‐fluciclovine PET Imaging in Glioma” blueearthdiagnostics.com ↗ “FDA had accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin® (fluciclovine F 18) in adults” 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)” 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 December 2, 2015” blueearthdiagnostics.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04840069 | Jun 2021 → Mar 2024 | glioblastoma | St. Joseph's Hospital and Medical Center, Phoenix | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05722925 | Oct 2023 → Dec 2026 expected | prostate cancer | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| 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 ↗
Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, today announced results from an investigational clinical trial (“FALCON”) evaluating the impact of 18F-fluciclovine PET/CT imaging on the clinical management of men with biochemically recurrent prostate cancer eligible for salvage therapy. |
| 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 ↗
Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced results of additional analyses from the LOCATE clinical trial (NCT02680041) in two presentations at the American Urological Association’s 2019 Annual Meeting, AUA2019, May 3-6, 2019 in Chicago, Ill. |
| 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 ↗
the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin® (fluciclovine F 18) in adults for the detection and continuing assessment of glioma. |
| 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 ↗
Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that the Transparency Committee of the French Haute Autorité de Santé (HAS) has recommended that Axumin® (fluciclovine (18F)) is included on the list of medicines approved in France for hospital use, in line with its European indication. |
| 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 ↗ |
| 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 ↗
Results of this study, based on PET/CT (computed tomography) images from the Axumin image database at Emory University, Atlanta, Ga., demonstrated that, with standardized Axumin reader training, previously naїve readers were able to achieve acceptable diagnostic performance and reproducibility when using Axumin PET/CT images to re-stage patients with biochemically recurrent prostate cancer. |
| 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 ↗
The CHMP’s positive opinion will now be reviewed by the European Commission. |
| 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 ↗
Results of the multi-center study, conducted in Norway, Italy and the United States, demonstrated a 68% overall detection rate (DR) for Axumin, with the ability to detect local, as well as distant, prostate cancer recurrence across a wide range of PSA values. |
| 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 ↗
Axumin is the first FDA-approved F18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer. |
| 2015-12-02 | Blue Earth Diagnostics | Regulatory Blue Earth Diagnostics and Siemens’ PETNET Solutions announce FDA acceptance of NDA filing for fluciclovine blueearthdiagnostics.com ↗
Blue Earth Diagnostics Ltd. (“BED”), a private diagnostics company, announced that a New Drug Application (NDA) filing for fluciclovine has been accepted by the U.S. Food and Drug Administration (FDA) for priority review. |
| 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 62 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluciclovine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04840069 ↗ |
| Known as | 18F-fluciclovine | “18F-fluciclovine is an FDA-approved radioactive diagnostic agent that is injected into the patient and then taken up by cancer cells, which can then be visualized with a PET/CT scan.” NCT04840069 ↗ |
| Modality | Diagnostic / imaging agent | “18F-fluciclovine is an FDA-approved radioactive diagnostic agent” NCT04840069 ↗ |
| Route | Intravenous | “Fluciclovine administered as a bolus intravenous injection” NCT05722925 ↗ |