Funduscein-25

(Fluorescein)

Phase 1Small molecule

FFalcon

Funduscein-25 is one of 93 small molecule programs targeting Breast Cancer. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

Endometrial CancerActive, not recruiting

Breast CancerPhase 1/Phase 2

Active, not recruiting

MelanomaPhase 1/Phase 2

Active, not recruiting

Endometrial CancerPhase 1

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Trodelvy

Gilead

Preclinical

37 2

Avastin

BBio-Thera Solutions

Preclinical

153 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Lexiscan

Astellas

Preclinical

1 5

Adenocard

Astellas

Preclinical

1 6

Voltaren

Novartis

Preclinical

1 7

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 8

Funduscein-25

FFalcon

Phase 1

1 9

Zinecard

CChildren's Oncology Group

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Intraoperative

NCT02691923

Phase 3Not yet recruiting

Substance Use Disorder

NCT07356349

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

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

Imaging1 trial

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

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

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

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

Intraoperative1 trial

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

Recruiting·—·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 1[1]
Company: FFalcon

Funduscein-25

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Gastrointestinal2 trials

Melanoma1 trial

Brain Tumors1 trial

Imaging1 trial

Endometrial Cancer1 trial

Substance Use Disorder1 trial

Breast Cancer1 trial

Intraoperative1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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