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Funduscein-25

(Fluorescein)

Phase 3Small molecule

Funduscein-25 is one of 22 small molecule programs targeting Imaging. It is currently in Phase 3.

2

Indications

10

Total Trials

2

Active Trials

21

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ImagingTerminated

Substance Use DisorderNot yet recruiting

ImagingPreclinical

Terminated

Substance Use DisorderPhase 3

Not yet recruiting

Competition

Competitive Landscape

34 competitors in Imaging

#DrugCompanyPhaseTrials

Nicorette

Ritalin

Obicetrapib

NNewAmsterdam Pharma

Funduscein-25

F-Arag

CCellSight Technologies, Inc.

Hyperpolarized 13c Pyruvate

UUniversity of Maryland, Baltimore

PET Scan With VAT

SStony Brook University

XTR006

SSinotau Pharmaceutical Group

Ga-FAPI-46

UUniversität Münster

Ethanol

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Substance Use Disorder

NCT07356349

Q4 2028

Phase 2Active, not recruiting

Brain Cancer

NCT02691923

Clinical

Trials by Indication[1]

Gastrointestinal2 trials

A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

Terminated·—·Phase 1·NCT01384695·67 enrolled

Advanced Gastrointestinal Endoscopic Imaging

Terminated·SStanford University·N/A·NCT01034670·3 enrolled

Imaging1 trial

Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon

Terminated·UUniversity of Michigan·N/A·NCT03220711·72 enrolled

Substance Use Disorder1 trial

Study to Confirm the AuthenTicity of Point of Care Urine samplEs Using Oral fluoreScein Sodium in adulTs With substancE Use Disorder (ATTESTED)

Not yet recruiting·UUpTru Inc.·Phase 3·NCT07356349·114 enrolled

Breast Cancer1 trial

Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer

Withdrawn·UUniversity of Utah·Phase 1/2·NCT01614184

Endometrial Cancer1 trial

Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion

Completed·UUniversity of Arkansas·Phase 1·NCT01979003·100 enrolled

4 more indications

Melanoma1 trial

Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma

Completed·UUniversity of Utah·Phase 1/2·NCT00847522·90 enrolled

Brain Tumors1 trial

Use of Fluorescein Dye for the Removal of Brain Tumors

Completed·UUniversity of Pittsburgh··NCT02389530·91 enrolled

Brain Cancer1 trial

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology

Active, not recruiting·DDavid W. Roberts·Phase 2·NCT02691923·30 enrolled

Unspecified1 trial

Evaluation of Fluorescein Use During Cystoscopy

Withdrawn·JJohns Hopkins University·N/A·NCT02703558

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

FUNDUSCEIN-25

NDA NDA017869

Mar 28, 2006

FLUORESCITE

NDA NDA021980

Aug 8, 2008

AK-FLUOR 10%

NDA NDA022186

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Fluorescein. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fluorescein compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fluorescein. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022186). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Falcon company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: FFalcon

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