LUMASON (sulfur hexafluoride lipid-type a microspheres)
Lumason is an imaging agent used to improve the clarity of ultrasound scans in both adult and pediatric patients. It helps clinicians better visualize the left ventricular chamber and heart borders during echocardiograms when standard images are suboptimal. Additionally, it is used to help characterize focal liver lesions and to evaluate children for suspected or known vesicoureteral reflux.
How LUMASON Works
This agent works by introducing microspheres into the body that have a lower acoustic impedance than the surrounding tissues. When an ultrasound beam hits the interface between these microspheres and the tissue, it reflects back to create a clear visual contrast on the imaging screen. In urinary tract applications, these microspheres increase the signal intensity of fluids within the bladder, ureters, and kidneys.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-10-10
- Patent Cliff
- 2039
- Routes
- INTRAVENOUS
- Dosage Forms
- FOR SUSPENSION
LUMASON Approval History
What LUMASON Treats
2 indicationsLUMASON is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Focal Liver Lesions
- Vesicoureteral Reflux
LUMASON Boxed Warning
SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions ( 5.1 )] . Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions ( 5.1 )] . Assess all patients for the presence of any condition that precludes administration [see Contraindications ( 4 )] . Always ...
WARNING: SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions ( 5.1 )] . Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions ( 5.1 )] . Assess all patients for the presence of any condition that precludes administration [see Contraindications ( 4 )] . Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions ( 5.1 )] . WARNING: SERIOUS CARDIOPULMONARY REACTIONS See full prescribing information for complete boxed warning Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres ( 5.1 ). Most serious reactions occur within 30 minutes of administration ( 5.1 ). Assess all patients for the presence of any condition that precludes administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
LUMASON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to LUMASON
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06600880 FUS-AD | AAAV4854 | Ph 1 | not yet recruiting | Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau |
| NCT06329570 | NF-2023-03 | Ph 1, Ph 2 | recruiting | Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM) |
| NCT06400004 | BR1-149 | Ph 3 | recruiting | Lumason® Infusion vs. Bolus Administrations |
| NCT04718441 | P00035263 | Ph 1, Ph 2 | completed | Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study) |
| NCT03549520 results posted | 18-014912 | Ph 3 | completed | CEUS Evaluation of Hypoxic Ischemic Injury |
| NCT03549507 results posted | 18-014910 | Ph 3 | terminated | CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis |
| NCT05613946 CASTLE | 22-006006 | Ph 1 | completed | Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema |
| NCT04640038 results posted | 20-017501 | Ph 3 | completed | Contrast Enhanced Ultrasound in COVID-19 |
| NCT04569799 TACE results posted | STUDY14930 | Ph 4 | completed | Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE |
| NCT03687502 results posted | Study00000329 | Ph 2 | completed | The Role of Contrast Enhanced Ultrasound in Appendicitis |
| NCT02552238 results posted | BR1-142 | Ph 3 | completed | Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142 |
| NCT03147690 results posted | P00025242 | Ph 1, Ph 2 | terminated | Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children |
| NCT02522481 results posted | BR1-141 | Ph 3 | completed | Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141 |
| NCT03295656 | IRB-P00025591 | Ph 1 | withdrawn | Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis |
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.
LUMASON FDA Label Details
Indications & Usage
FDA Label (PDF)LUMASON is indicated for the treatment of Focal Liver Lesions; Vesicoureteral Reflux.
WARNING: SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions ( 5.1 )] . Most serious reactio...
Pro Intelligence Preview
Deep insights for LUMASON
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 5 active patents
Trial Analysis
- • 14 total trials
- • Stage: Stable
Competitive Landscape
- • 1 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment