Navidea (NO1A) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Tc99m-Tilmanocept | Rheumatoid Arthritis | Phase III | Terminated | Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA | Dec 16, 2021 | ― |
| Tc99m Tilmanocept | Rheumatoid Arthritis | Phase II | Completed | Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept | May 10, 2021 | ― |
| Tc 99M Tilmanocept | Rheumatoid Arthritis | Phase II | Terminated | Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA | Aug 21, 2019 | ― |
| Tc 99M Tilmanocept | Rheumatoid Arthritis | Phase II | Completed | Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging | Apr 24, 2019 | ― |
| Tc99m-Tilmanocept, Tc 99M Sulfur Colloid | Nonalcoholic Steatohepatitis, Nash - Nonalcoholic Steatohepatitis | Phase I | Terminated | Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH | Nov 01, 2017 | ― |
| Tilmanocept | Arthritis, Rheumatoid | Phase I | Withdrawn | Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) | Jul 25, 2017 | ― |
| Tc99m-Tilmanocept | Hiv Infections, Kaposi Sarcoma | Phase I | Completed | An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS) | May 04, 2017 | ― |
| Tilmanocept (Technetium Tc 99M Tilmanocept Injection), Spect/Ct Imaging | Colorectal Carcinoma, Liver Metastases | Phase I | Terminated | An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases. | Jan 20, 2017 | ― |
| Tc99m-Tilmanocept, Spect Imaging (60 Minutes Post-Injection), Spect Imaging (180 Minutes Post-Injection), Whole Body Planar Spect Imaging (15 Minutes Post-Injection), Whole Body Planar Spect Imaging (60 Minutes Post-Injection), Whole Body Planar Spect Imaging (180 Minutes Post-Injection), Whole Body Planar Spect Imaging (18-20 Hours Post-Injection), Blood Collection For Pk Testing (15 Mins Before Injection), Blood Collection For Pk Testing (After Injection), Blood Collection For Pk Testing (15 Minutes Post Injection), Blood Collection For Pk Testing (60 Minutes Post Injection), Blood Collection For Pk Testing (180 Minutes Post Injection), Blood Collection For Pk Testing (18-20 Hours Post Injection), Planar Image With Both Hands In Field Of View | Arthritis, Rheumatoid | phase1AndPhase2 | Completed | Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA | Aug 05, 2016 | ― |
| Tilmanocept | Rheumatoid Arthritis | Phase I | Completed | Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging | Jan 22, 2016 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Tc99m-Tilmanocept | Phase III | Rheumatoid Arthritis | Terminated | Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA | Dec 16, 2021 | ― |
| Tc99m Tilmanocept | Phase II | Rheumatoid Arthritis | Completed | Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept | May 10, 2021 | ― |
| Tc 99M Tilmanocept | Phase II | Rheumatoid Arthritis | Terminated | Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA | Aug 21, 2019 | ― |
| Tc 99M Tilmanocept | Phase II | Rheumatoid Arthritis | Completed | Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging | Apr 24, 2019 | ― |
| Tc99m-Tilmanocept, Tc 99M Sulfur Colloid | Phase I | Nonalcoholic Steatohepatitis, Nash - Nonalcoholic Steatohepatitis | Terminated | Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH | Nov 01, 2017 | ― |
| Tilmanocept | Phase I | Arthritis, Rheumatoid | Withdrawn | Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) | Jul 25, 2017 | ― |
| Tc99m-Tilmanocept | Phase I | Hiv Infections, Kaposi Sarcoma | Completed | An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS) | May 04, 2017 | ― |
| Tilmanocept (Technetium Tc 99M Tilmanocept Injection), Spect/Ct Imaging | Phase I | Colorectal Carcinoma, Liver Metastases | Terminated | An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases. | Jan 20, 2017 | ― |
| Tc99m-Tilmanocept, Spect Imaging (60 Minutes Post-Injection), Spect Imaging (180 Minutes Post-Injection), Whole Body Planar Spect Imaging (15 Minutes Post-Injection), Whole Body Planar Spect Imaging (60 Minutes Post-Injection), Whole Body Planar Spect Imaging (180 Minutes Post-Injection), Whole Body Planar Spect Imaging (18-20 Hours Post-Injection), Blood Collection For Pk Testing (15 Mins Before Injection), Blood Collection For Pk Testing (After Injection), Blood Collection For Pk Testing (15 Minutes Post Injection), Blood Collection For Pk Testing (60 Minutes Post Injection), Blood Collection For Pk Testing (180 Minutes Post Injection), Blood Collection For Pk Testing (18-20 Hours Post Injection), Planar Image With Both Hands In Field Of View | phase1AndPhase2 | Arthritis, Rheumatoid | Completed | Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA | Aug 05, 2016 | ― |
| Tilmanocept | Phase I | Rheumatoid Arthritis | Completed | Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging | Jan 22, 2016 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Navidea Biopharmaceuticals (DE:NO1A) have in its pipeline
Navidea DE:NO1A is currently developing the following drugs: Tc99m-Tilmanocept, Tc99m Tilmanocept, Tc 99M Tilmanocept, Tc99m-Tilmanocept, Tc 99M Sulfur Colloid, Tilmanocept, Tilmanocept (Technetium Tc 99M Tilmanocept Injection), Spect/Ct Imaging, Tc99m-Tilmanocept, Spect Imaging (60 Minutes Post-Injection), Spect Imaging (180 Minutes Post-Injection), Whole Body Planar Spect Imaging (15 Minutes Post-Injection), Whole Body Planar Spect Imaging (60 Minutes Post-Injection), Whole Body Planar Spect Imaging (180 Minutes Post-Injection), Whole Body Planar Spect Imaging (18-20 Hours Post-Injection), Blood Collection For Pk Testing (15 Mins Before Injection), Blood Collection For Pk Testing (After Injection), Blood Collection For Pk Testing (15 Minutes Post Injection), Blood Collection For Pk Testing (60 Minutes Post Injection), Blood Collection For Pk Testing (180 Minutes Post Injection), Blood Collection For Pk Testing (18-20 Hours Post Injection), Planar Image With Both Hands In Field Of View, Nav5001, Datscan, Nav5001, [18F]Nav4694. These drug candidates are in various stages of clinical development as the company works toward FDA approval.