Last Updated: August 10, 2026

CLINICAL TRIALS PROFILE FOR FLUORESCITE


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All Clinical Trials for FLUORESCITE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00847522 ↗ Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma Completed University of Utah Phase 1/Phase 2 2009-02-01 The purpose of this research study is to use two different drugs to find where melanoma might spread and to remove these tissues. We believe that tumor cells from the melanoma first move through the lymphatic system (a system of clear fluid that moves around the body and carries white blood cells, much like the blood system) to a lymph node in an orderly way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can detect about 90% of the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive compound and can be detected through the skin by a special instrument that reads radioactivity. As part of this research, we would like to use a second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph nodes or additional ones and examine these. This drug is fluorescent and can be detected even through the skin using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely used in people for many years. In this study, we will be injecting it under the skin, which is a different use from how it is currently approved by the FDA. In the past another drug has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is currently limited, and it has higher risks associated with it. This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and at University of Utah. This study is a Phase I/II and is done to find out if the drug can be used safely when given under the skin and if it will work for this purpose.
NCT01886235 ↗ Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery Completed National Cancer Institute (NCI) N/A 2013-09-04 This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
NCT01886235 ↗ Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery Completed Roswell Park Cancer Institute N/A 2013-09-04 This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FLUORESCITE

Condition Name

Condition Name for FLUORESCITE
Intervention Trials
Stage IB Skin Melanoma 2
Stage IIIA Skin Melanoma 2
Stage IIIB Skin Melanoma 2
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Condition MeSH

Condition MeSH for FLUORESCITE
Intervention Trials
Melanoma 3
Heart Septal Defects 2
Skin Neoplasms 2
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Clinical Trial Locations for FLUORESCITE

Trials by Country

Trials by Country for FLUORESCITE
Location Trials
United States 8
Canada 2
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Trials by US State

Trials by US State for FLUORESCITE
Location Trials
New York 3
Massachusetts 2
Michigan 1
New Hampshire 1
Utah 1
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Clinical Trial Progress for FLUORESCITE

Clinical Trial Phase

Clinical Trial Phase for FLUORESCITE
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 1
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for FLUORESCITE
Clinical Trial Phase Trials
Completed 6
Recruiting 3
Active, not recruiting 1
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Clinical Trial Sponsors for FLUORESCITE

Sponsor Name

Sponsor Name for FLUORESCITE
Sponsor Trials
National Cancer Institute (NCI) 3
Roswell Park Cancer Institute 3
National Heart, Lung, and Blood Institute (NHLBI) 2
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Sponsor Type

Sponsor Type for FLUORESCITE
Sponsor Trials
Other 12
NIH 6
Industry 2
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Last updated: July 28, 2026

Fluorescite clinical trials update, market analysis, and price/revenue projections

Fluorescite (fluorescein sodium injection) is used as a diagnostic imaging agent for ophthalmic and vascular applications, with commercialization driven by hospital procedure volume, ophthalmology practice patterns, and reimbursement coverage for fluorescein-based retinal angiography and related imaging workflows. Public, trial-level timing, endpoints, and participant counts are not available in the provided material, and no market and revenue inputs (pricing, utilization, geographies, channel mix, or managed-entry terms) are supplied.

No complete and accurate clinical trials update or forecast can be produced from the information in this request alone.


What clinical trials are ongoing for Fluorescite (fluorescein sodium) and what are the latest results?

No trial registry details, sponsor information, study identifiers (e.g., NCT numbers), recruitment status, or results data are provided, so a clinical trials update cannot be constructed to publication-grade standards.

Which indications are being studied for fluorescein sodium imaging products?

No indication mapping (ophthalmic angiography vs vascular imaging vs surgical visualization), study phase, or comparator/control arms are provided.

What endpoints matter for fluorescein imaging products in clinical studies?

No endpoints data (e.g., vessel visualization grade, sensitivity/specificity vs comparator dyes/imaging modalities, adverse event profiles) is provided.


How big is the Fluorescite market and what growth drivers affect fluorescein sodium demand?

No market size baseline, country segmentation, utilization rates, pricing assumptions, or reimbursement coverage data are provided, so market sizing and growth projections cannot be calculated accurately.

Which reimbursement and procedure volumes drive Fluorescite utilization?

No reimbursement coverage, CPT/HCPCS coding context, payer policy, or procedural volumes are provided.

What competitive factors influence fluorescein-based imaging product demand?

No competitor list (brands/generics), pricing dispersion, tender dynamics, or supply constraints are provided.


When do Fluorescite revenues peak and what is the forecast horizon for fluoroscene-based diagnostic imaging?

No historical sales curve, launch history, penetration trajectory, or manufacturing/supply constraints are provided, so peak timing and a forecast horizon cannot be produced.

What adoption model fits fluorescein imaging products (hospital vs outpatient)?

No channel mix or site-of-care distribution is provided.

How do switching and procurement cycles affect quarterly demand?

No procurement cycle data, contract duration, or formulary status inputs are provided.


What are current market price benchmarks for Fluorescite (fluorescein sodium injection) by strength and package?

No product strength, package configuration, NDC-level pricing, wholesale acquisition cost, or secondary market pricing is provided, so no benchmarks can be produced.

How do competitors’ pricing and pack size compare with Fluorescite?

No competitor pricing or pack-size data is provided.

What discounting and contract terms are typical in the fluorescein imaging segment?

No contracting or rebate data is provided.


How strong is the patent and exclusivity position for Fluorescite, and what does it imply for future competition?

No Orange Book listings, patent numbers, expiry dates, or exclusivity periods are provided. Without that, patent strength and competition risk cannot be evaluated.

What patents protect fluorescein sodium formulations and methods of use?

No patent estate data is provided.

Does Fluorescite face generic or biosimilar-style entry risk?

Fluorescein sodium is a small-molecule imaging agent, so “biosimilar-style” risk is not the right construct, but no regulatory entry pathway information is provided.


What is the regulatory status of Fluorescite with the FDA (Orange Book, labeling, and pathways)?

No FDA submission details, labeling updates, or Orange Book entries are provided, so regulatory status cannot be confirmed.

What are the latest labeling changes affecting clinical use?

No labeling revisions, safety communications, or administration constraints are provided.

Is Fluorescite subject to REMS, postmarketing requirements, or safety monitoring?

No postmarketing commitments or safety monitoring information is provided.


What manufacturing and supply risks could affect Fluorescite availability and sales?

No supplier base, manufacturing site risk, sterile fill-finish constraints, lead times, or prior supply disruptions are provided.

Are there sterility assurance or sourcing vulnerabilities for fluorescein sodium?

No CMC risk indicators are provided.


Key Takeaways

  • A publication-grade clinical trials update for Fluorescite requires trial identifiers and results data that are not provided in the request.
  • A defensible market analysis and revenue projection requires baseline sales/utilization, pricing, geography, and reimbursement inputs that are not provided.
  • No regulatory (Orange Book) and patent inputs are provided, so exclusivity-driven forecast modeling cannot be built.

FAQs

  1. What NCT trials exist for fluorescein sodium diagnostic imaging and what are their current statuses?
  2. How does fluorescein sodium pricing vary by NDC, package size, and geography?
  3. What are the main clinical endpoints used in retinal angiography studies with fluorescein?
  4. What FDA labeling restrictions or safety communications influence fluorescein sodium administration?
  5. What generic entry pathways apply to fluorescein sodium injection products in the US?

References (APA)

  1. No sources were provided in the request.

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