TheraRadar
Data updated: May 26, 2026

GLOFIL-125 (iothalamate sodium i-125)

Renal Approved 1974-02-12

GLOFIL-125 is indicated for the treatment of Renal Disease.

Source: FDA Label • ISOTEX
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1
Indication
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1974-02-12
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

ISOTEX
Active Ingredient: IOTHALAMATE SODIUM I-125

GLOFIL-125 Approval History

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Original
New Indication
New Form
Label Update
6 FDA actions from 1974 to 2002
Jan 2002 SUPPL
Label · Labeling
FDA Letter
Mar 1997 SUPPL
Label · Labeling
Aug 1994 SUPPL
Label · Labeling

What GLOFIL-125 Treats

1 indications

GLOFIL-125 is approved for 1 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Renal Disease
Source: FDA Label

GLOFIL-125 Competitive Set

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Indication competitors

9

Same indication, different mechanism — what else might this patient receive?

ENBUMYST
CORSTASIS THERAP
2025 5 indic.
INZIRQO
NOVITIUM PHARMA
2025 6 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to GLOFIL-125

3 of 9

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BUMETANIDE
BUMETANIDE
1 shared
ZYDUS PHARMS
Shared indications:
Renal Disease
BUMEX
BUMETANIDE
1 shared
VALIDUS PHARMS
Shared indications:
Renal Disease
EDECRIN
ETHACRYNATE SODIUM
1 shared
BAUSCH
Shared indications:
Renal Disease
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Active Pipeline

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Key Completed Trials

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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.

GLOFIL-125 FDA Label Details

Indications & Usage

GLOFIL-125 is indicated for the treatment of Renal Disease.

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Data Sources

FDA Approval: NDA017279 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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