OnCo
drugsProductApproved2023

Flotufolastat F-18

Flotufolastat is a third PSMA PET tracer, with a radiohybrid chemistry designed to be reused for therapy.

LIGHTHOUSE (initial staging) and SPOTLIGHT (biochemical recurrence) trials; approved May 2023. Low urinary excretion aids pelvic reading.

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rhPSMA-7.3 (flotufolastat) · 2D coordinates (no PubChem conformer)
PubChem
Modality
PET imaging agent
Mechanism
Radiohybrid PSMA ligand; silicon-fluoride acceptor allows 18F imaging and 177Lu therapy on the same scaffold.
Brand / code
Posluma · 18F-rhPSMA-7.3
Medicare
Part B (clinician-administered)

Diagnostic radiopharmaceutical billed with the PET/CT scan under Part B; same coverage pathway as other PSMA PET agents.

Commercial insurance
covered with prior authorisation

Commercial plans cover PSMA PET for staging and recurrence with prior authorisation of the imaging procedure.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Diagnostic non-laboratory tests (imaging). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: flotufolastat F-18. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2023PSMA PET in prostate cancer

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
11 studies5 recruiting10 Phase 21 Phase 3
Search “Flotufolastat F-18” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Flotufolastat F-18
intervention: Flotufolastat F-18
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend4 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Flotufolastat F-18" OR ABSTRACT:"Flotufolastat F-18" OR TITLE:"Posluma" OR ABSTRACT:"Posluma" OR TITLE:"18F-rhPSMA-7.3" OR ABSTRACT:"18F-rhPSMA-7.3") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Flotufolastat F-18, not a curated reading list.

Connected

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