NDAINTRAVENOUSSOLUTION
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
POSLUMA (flotufolastat f-18) by Blue Earth Diagnostics is positron emitting activity [moa]. First approved in 2023.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
POSLUMA (flotufolastat F-18) is an intravenous radioactive diagnostic agent that uses positron-emitting activity to enable molecular imaging. It is indicated for positron emission tomography (PET) imaging in patients with suspected or known prostate cancer. The drug works by targeting folate receptor-positive cells, allowing clinicians to detect and localize malignant lesions.
Peak15.4 years to LOE
Recently approved (May 2023) in peak commercial phase with no direct competitors, positioning the brand team for aggressive market expansion and growth-stage hiring.
Mechanism of Action
Positron Emitting Activity
Pharmacologic Class:
Radioactive Diagnostic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Androgen-responsive POSLUMA-guided Intra-prostatic Boost
Started Apr 2026
23 enrolled
Intermediate Risk Prostate CancerHigh Risk Prostate CancerProstate Cancer
Why This Matters for Your Career
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.