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Posluma (FLOTUFOLASTAT)
Posluma (generic name: FLOTUFOLASTAT) is a Radioactive Diagnostic Agent [EPC] Small molecule drug developed by Blue Earth. It is currently FDA-approved (first approved 2025) for prostate cancer with suspected metastasis, suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Posluma works by emitting radiation that helps doctors visualize and diagnose prostate cancer.
Posluma (flotufolastat) is a radioactive diagnostic agent developed by Blue Earth, currently owned by the same company. It is a small molecule used to diagnose prostate cancer with suspected metastasis or recurrence based on elevated PSA levels. Posluma received FDA approval in 2025. The commercial status of Posluma is patented, with no generic manufacturers available. Key safety considerations include the radioactive nature of the agent, which requires proper handling and administration.
At a glance
| Generic name | FLOTUFOLASTAT |
|---|---|
| Sponsor | Blue Earth |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Mechanism of action Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA. Fluorine-18 is a ß+ emitting radionuclide that can be detected using positron emission tomography.
Approved indications
- prostate cancer with suspected metastasis
- suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
Common side effects
- Diarrhea
- Blood pressure increase
- Injection site pain
Drug interactions
- Androgen deprivation therapy (ADT)
- Androgen receptor antagonists
Key clinical trials
- Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. (PHASE3)
- 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)
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (PHASE2)
- Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance (PHASE2)
- Androgen-responsive POSLUMA-guided Intra-prostatic Boost (PHASE2)
- Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (PHASE1,PHASE2)
- Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer (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
Frequently asked questions about Posluma
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Related
- Drug class: All Radioactive Diagnostic Agent [EPC] drugs
- Manufacturer: Blue Earth — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for prostate cancer with suspected metastasis
- Indication: Drugs for suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing