POSLUMA (flotufolastat f-18 gallium)
Posluma is a radioactive diagnostic agent used during PET imaging to locate specific lesions in men with prostate cancer. It helps healthcare providers identify suspected metastatic disease in patients who are candidates for initial definitive therapy. It is also used to evaluate patients who may have a cancer recurrence based on rising prostate-specific antigen (PSA) levels.
How POSLUMA Works
This agent works by binding to prostate-specific membrane antigen (PSMA), a protein that is typically overexpressed on the surface of prostate cancer cells. Once bound, the drug is internalized into the cells, where the radioactive fluorine-18 component emits signals that are detected through positron emission tomography (PET). This process allows for the visualization of PSMA-positive lesions throughout the body.
Details
- Status
- Prescription
- First Approved
- 2023-05-25
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
POSLUMA Approval History
What POSLUMA Treats
3 indicationsPOSLUMA is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
- Metastasis
- Recurrence
POSLUMA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in POSLUMA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications POSLUMA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to POSLUMA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06865768 | STUDY00007915 NCI-2025-00207, STUDY00007915 | Ph 2 | recruiting | An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
POSLUMA FDA Label Details
Indications & Usage
FDA Label (PDF)POSLUMA is indicated for the treatment of Prostate Cancer; Metastasis; Recurrence.
POSLUMA Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for POSLUMA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.