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Posluma (FLOTUFOLASTAT F-18 GALLIUM)
Posluma works by binding to glutamate carboxypeptidase 2, a protein found in certain types of cancer cells.
At a glance
| Generic name | FLOTUFOLASTAT F-18 GALLIUM |
|---|---|
| Sponsor | Blue Earth |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Target | Glutamate carboxypeptidase 2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Imagine Posluma as a key that fits into a specific lock on cancer cells. When it binds to this lock, it helps doctors see where the cancer is located using a special imaging test called positron emission tomography. This allows for more accurate diagnosis and treatment.
Approved indications
- Positron emission tomography
Common side effects
- Diarrhea
- Blood pressure increase
- Injection site pain
Key clinical trials
- Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (PHASE2)
- Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial (EARLY_PHASE1)
- Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (PHASE1,PHASE2)
- Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer (NA)
- [18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer (NA)
- An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique (PHASE2)
- rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance (EARLY_PHASE1)
- An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial (EARLY_PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Posluma CI brief — competitive landscape report
- Posluma updates RSS · CI watch RSS
- Blue Earth portfolio CI