NDAINTRAVENOUSSOLUTION
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
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 19h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
POSLUMA (flotufolastat F-18) is a radioactive diagnostic agent that emits positrons for use in positron emission tomography (PET) imaging. It is administered intravenously as a solution and functions as a molecular imaging tracer to detect disease at the cellular level. The drug enables clinicians to visualize and diagnose conditions through nuclear medicine imaging without therapeutic intent.
Peak15.2 years to LOE
Early-stage peak commercial phase with 113 linked positions indicates rapid organizational growth and expansion across commercial, medical affairs, and supply chain functions.
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 (2)
Effectiveness of Posluma PET Scan for Post-Treatment Monitoring of Prostate Cancer
Started Aug 2026
22 enrolled
Prostate Cancer
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.