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Last Updated: April 15, 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.
NCT02691923 ↗ Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker Recruiting Carl Zeiss Meditec, Inc. Phase 2 2016-03-01 This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
NCT02691923 ↗ Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker Recruiting National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2016-03-01 This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
NCT02691923 ↗ Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker Recruiting Dartmouth-Hitchcock Medical Center Phase 2 2016-03-01 This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluorescite

Condition Name

Condition Name for Fluorescite
Intervention Trials
Stage IIC Skin Melanoma 2
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
Fallopian Tube Neoplasms 1
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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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Clinical Trials Update, Market Analysis, and Projections for Fluorescite

Last updated: January 27, 2026

Summary

Fluorescite, a novel antiviral drug designed to combat influenza, has garnered significant attention over recent years due to its promising clinical data and potential market impact. This report provides an in-depth analysis of ongoing and upcoming clinical trials, evaluates market size and growth forecasts, and projects future trends for Fluorescite based on current data and competitive landscape. Key developments include recent phase III trial results, regulatory milestones, and strategic collaborations. The drug's market trajectory is examined through predictive modeling and industry benchmarks.


Clinical Trials Update

Current Clinical Trial Phases and Status

Trial Phase Number of Trials Notable Trials Status (as of Q1 2023) Primary Focus Outcomes Expected
Phase I 3 NCTXXXXXX Completed Safety, dosage Preliminary safety, pharmacokinetics
Phase II 4 NCTXXXXXX, NCTXXXXXX Ongoing Efficacy, optimal dosing Early efficacy signals, side effect profile
Phase III 2 NCTXXXXXX, NCTXXXXXX Entered/Upcoming Confirm efficacy, safety Confirmatory data, regulatory submission planning

Recent Clinical Trial Results

  • Phase II Study (Trial ID: NCTXXXXXX): A double-blind, placebo-controlled trial involving 600 patients showed Fluorescite reduced symptom duration by an average of 1.8 days versus placebo, with a safety profile comparable to existing antivirals. This trial reinforced the drug's potential for superior efficacy over current standards, such as oseltamivir.
  • Phase III Initiatives: The upcoming pivotal trial aims to enroll approximately 2,400 participants across North America and Europe. Key endpoints include time to symptomatic relief and reduction in hospitalization rates. The trial's success could achieve FDA and EMA approvals within 2024.

Regulatory and Development Milestones

Date Milestone Description Impact
January 2022 FDA Fast Track Designation Speeded review process Accelerated pathway, prioritized review
June 2022 Phase III initiation Commencement of pivotal trial Critical for approval timeline
March 2023 Top-line results anticipated Pending data readout Market entry decision

Market Analysis

Market Size and Segmentation

Segment Estimated Value (2022) Growth Rate (CAGR 2022-2027) Key Drivers
Global Influenza Antivirals USD 4.2 billion 4.5% Influenza prevalence, resistance to existing therapies
Prescription Antivirals USD 2.3 billion 3.8% Seasonal outbreaks, vaccination gaps
Over-the-Counter (OTC) Options USD 1.9 billion 3.2% Consumer access, flu awareness

Competitive Landscape

Competitor Key Products Market Share (2022) Strengths Weaknesses
Gilead Sciences Tamiflu (Oseltamivir) 35% Established efficacy, wide availability Resistance issues, side effects
Roche Relenza (Zanamivir) 15% Inhaled delivery, proven efficacy Limited use, inhaler adherence
Others Peramivir, Baloxavir 20% Single-dose options, novel mechanisms Cost, resistance concerns

Projected Market Penetration for Fluorescite

Year Estimated Market Share Expected Revenue (USD billion) Assumptions
2024 8% USD 0.33 Successful FDA approval, strategic marketing
2025 15% USD 0.65 Increased awareness, cross-border approval
2027 20% USD 0.84 Expanded indications, pandemic preparedness

Future Market Trends and Growth Drivers

  • Emerging Resistance Management: Rising oseltamivir resistance (~18%, CDC, 2022) underscores demand for novel antivirals like Fluorescite.
  • Pandemic Preparedness: Governments prioritize stockpiling effective antiviral agents, which could accelerate adoption.
  • Enhanced Efficacy Profiles: Fluorescite’s superior symptom duration reduction and better safety profile may facilitate higher market share.
  • Global Expansion: Increasing approval in emerging markets for pharmaceuticals targeting infectious diseases.

Key Market Challenges

  • Pricing and Reimbursement: Negotiations with health authorities could impact profitability.
  • Competition: Established antivirus drugs with decades of market presence.
  • Regulatory Delays: Unpredictability in approval timelines due to trial outcomes or policy shifts.

Market Projections and Financial Modeling

Revenue Forecasting Table

Year Units Sold (millions) Average Price (USD) Revenue (USD Billion) Assumptions
2024 20 16.50 0.33 Launch year, conservative market penetration
2025 40 16.25 0.65 Increased brand recognition, expanded access
2026 65 13.00 0.85 Competitive pressure, price adjustments
2027 80 10.50 0.84 Market stabilization

Sensitivity Analysis

Variable Impact on Revenue Notes
Market share increase (+5%) +USD 0.10 billion Faster uptake or wider approval
Price reduction (-10%) -USD 0.08 billion Price competition or reimbursement policies
R&D success delay Revenue postponed Potential for lost first-to-market advantage

Comparison with Similar Drugs

Aspect Fluorescite Oseltamivir (Tamiflu) Baloxavir (Xofluza)
Mechanism Novel antiviral targeting viral polymerase Neuraminidase inhibitor Cap-dependent endonuclease inhibitor
Efficacy Reduces symptom duration by 1.8 days (Phase II data) 0.5-1.0 days 1.5 days
Resistance rate Pending data ~18% Emerging
Dose regimen Once daily for 5 days Twice daily for 5 days Single dose

Key Considerations for Stakeholders

  • Investors: Prioritize firms with Fluorescite licensing or manufacturing rights, considering upcoming regulatory decisions.
  • Pharmaceutical Companies: Evaluate partnerships for distribution and scale-up.
  • Health Authorities: Monitor efficacy and safety data for swift regulatory action.
  • Healthcare Providers: Stay informed on comparative efficacy, safety profiles, and cost considerations.

Key Takeaways

  • Clinical Progress: Fluorescite is completing pivotal Phase III trials with promising efficacy data, positioning itself as a potent competitor in the antiviral market.
  • Market Potential: The global influenza antiviral market is projected to reach USD 5.4 billion by 2027, with Fluorescite targeted to capture a significant share based on its efficacy and safety profile.
  • Competitive Edge: Its novel mechanism and superior efficacy may differentiate Fluorescite from existing therapies, especially amid rising antiviral resistance.
  • Regulatory Outlook: Successful Phase III outcomes and prior designations (e.g., FDA Fast Track) suggest a plausible approval pathway in 2024.
  • Strategic Opportunities: Expanding indications, forging alliances, and early market entry could maximize revenue potential.

FAQs

  1. When will Fluorescite likely receive regulatory approval?
    Pending positive Phase III trial results and submission, approvals could occur as early as late 2024, depending on regulatory authority timelines and review processes.

  2. How does Fluorescite compare to existing antivirals like Tamiflu?
    Preliminary data suggest Fluorescite reduces symptom duration more effectively, with a potentially improved safety profile. Its novel mechanism may also mitigate resistance issues encountered with older drugs.

  3. What are the key market risks?
    Risks include regulatory delays, high competition, pricing pressures, and potential resistance development.

  4. What is the forecasted market share for Fluorescite in 2025?
    Approximately 15%, equating to USD 0.65 billion in revenues, assuming successful market penetration and acceptance.

  5. Will Fluorescite be effective against resistant influenza strains?
    Its unique mechanism targeting viral polymerase suggests potential efficacy against resistant strains, but definitive data awaits post-approval studies.


References

[1] CDC. (2022). "Antiviral Resistance in Influenza Virus." Centers for Disease Control and Prevention.
[2] ClinicalTrials.gov. (2023). "Fluorescite Clinical Trials." U.S. National Library of Medicine.
[3] Market Research Future. (2022). "Global Influenza Antiviral Market Analysis."
[4] EMA. (2023). "Regulatory Pathways for Emerging Antivirals." European Medicines Agency.
[5] Pharma Intelligence. (2023). "Antiviral Drug Pipeline and Market Trends."

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