drugset
Drugs / Flotufolastat F 18
last change Jun 2026 re-read 9 days ago

Flotufolastat F 18

also known as 18F-rhPSMA-7.3 · flotufolastat (18F)

Diagnostic / imaging agent

Investigated by
Aixial Group · Blue Earth Diagnostics · Sinotau Pharmaceutical Group · University of Florida

Trials 3

today NCT07220720 · Ph 2 NCT07149831 · Ph 1 NCT06604442 · Ph 4
202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07149831 Jun → Dec 2025 overdue prostate cancer Sinotau Pharmaceutical Group Recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT07220720 Nov 2025 → Jul 2030 expected prostate cancer University of Florida Recruiting No outcome recorded
Phase 41 trial · 1 met primary
Phase 4 NCT06604442 Dec 2024 → Aug 2025 prostate cancer Blue Earth Diagnostics Completed Met primary
Comparator or background therapy1 trial
Phase 1/2 NCT06881823 Comparator Jun 2026 → Mar 2030 prostate cancer Novartis Pharmaceuticals Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
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 ↗
Across multiple studies, POSLUMA demonstrated strong performance in detecting biochemical recurrence following radical prostatectomy, particularly at low PSA levels where conventional imaging remains limited.
2026-02-27 Blue Earth Diagnostics Results Blue Earth Diagnostics Announces Positive Results from Head-to-Head Comparator Study of POSLUMA® (Flotufolastat F 18) and Piflufolastat F 18 Urinary Bladder Radioactivity in Men with Biochemical Recurrence of Prostate Cancer blueearthdiagnostics.com ↗
The study met its primary endpoint, demonstrating statistically significant lower urinary bladder radioactivity with POSLUMA compared with piflufolastat F 18, as measured by mean standardized uptake value (SUVmean).
2024-07-30 Blue Earth Diagnostics Results Blue Earth Diagnostics, a Bracco Company, Announces Results Evaluating Diagnostic Performance of POSLUMA® (Flotufolastat F 18) and Clinical Trial Enrollment in African American Men with Prostate Cancer blueearthdiagnostics.com ↗
2023-04-29 Blue Earth Diagnostics Results Blue Earth Diagnostics Announces Additional Results from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer − Results at the American Urological Association’s 2023 Annual Meeting (AUA2023) blueearthdiagnostics.com ↗
The results were reported in a moderated poster presentation at the American Urological Association’s 2023 Annual Meeting (AUA2023), in Chicago, Ill.

All press releases naming this drug 33 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Flotufolastat F-18 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07149831 ↗
2

NCT06881823 ↗

NCT07220720 ↗
Known as 18F-rhPSMA-7.3 “PSMA-PET radiopharmaceuticals, 18F-piflufolastat (18F-DCFPyL) and 18F-flotufolastat (18F-rhPSMA-7.3) in patients with biochemical recurrence (BCR) of prostate cancer” PMID 41729277 ↗ Feb 2026
Known as flotufolastat (18F) ClinicalTrials.gov intervention name — accepted as the source's own label NCT06604442 ↗
Modality Diagnostic / imaging agent “positron emission tomography (PET) imaging tracer” NCT07149831 ↗
Route Intravenous “Subjects will receive 5.47\~6.69mCi of Flotufolastat F-18 Injection via IV injection.” NCT07149831 ↗