TheraRadar
Data updated: May 26, 2026

FLUORESCEIN SODIUM

Trial Activity: Stable 2 active trials
Ophthalmology Approved 2023-09-25

INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT).

Source: FDA Label • NEXUS
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Memorial Sloan Kettering Cancer Center conducting 1 trials (17%)
12 indications explored (Broad Platform)
→ extramammary paget's disease (1 trials)
→ pleomorphic adenoma of the parotid (1 trials)
→ warthin tumor (1 trials)
2
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-09-25
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

NEXUS BPI LABS
Active Ingredient: FLUORESCEIN SODIUM

FLUORESCEIN SODIUM Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2023 to 2026
Apr 2026 ORIGINAL
Update
Sep 2023 ORIGINAL
Update
FDA Letter

What FLUORESCEIN SODIUM Treats

2 FDA approvals

Originally approved for its first indication in 2023 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT06873815 25-002 Ph 2 recruiting A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
NCT06054178 results posted 71857 R25DC020174-03 Ph 2 completed Identification of Nerves Using Fluorescein Sodium
NCT05664555 DOSE B-2211-790-004 Ph 4 completed Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)
NCT04351373 results posted 19-005178 Ph 2 completed Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
NCT04071080 PH1.20180001 Ph 1 completed The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
NCT02028325 Fluorescein results posted GCBS-0003 Ph 4 terminated Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FLUORESCEIN SODIUM FDA Label Details

Indications & Usage

INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT).

Looking for the branded version?

FLUORESCITE

Full clinical data, patents, trials, and competitive landscape for fluorescein sodium.

See FLUORESCITE

Data Sources

FDA Approval: ANDA215709 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment