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Lymphoseek Kit (TECHNETIUM TC 99M TILMANOCEPT)
Lymphoseek Kit (Technetium TC 99M Tilmanocept) is a radioactive diagnostic agent developed by Navidea Biopharmaceuticals. It is a small molecule that works by binding to specific targets in the body, allowing for imaging of lymph nodes. Lymphoseek Kit is FDA-approved for use as a diagnostic aid, and its commercial status is patented. Key safety considerations include radiation exposure and potential allergic reactions. It is used to help identify cancerous lymph nodes.
At a glance
| Generic name | TECHNETIUM TC 99M TILMANOCEPT |
|---|---|
| Sponsor | Navidea Biopharms |
| Drug class | Radioactive Diagnostic Agent |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2013 |
Approved indications
- Diagnostic aid
Common side effects
- Injection site irritation
- Injection site pain
Key clinical trials
- Repurposing Tilmanocept for Cardiac Sarcoidosis (PHASE2)
- Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial (PHASE2)
- An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS) (PHASE1)
- Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA (PHASE3)
- Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept (PHASE2)
- Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA (PHASE2)
- Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH (PHASE1)
- A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping (PHASE2)
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:
- Lymphoseek Kit CI brief — competitive landscape report
- Lymphoseek Kit updates RSS · CI watch RSS
- Navidea Biopharms portfolio CI