TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

MESNA

MESNA
Hematology Approved 2001-04-26
9
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Prescription
First Approved
2001-04-26
Routes
INTRAVENOUS, ORAL, Injection
Dosage Forms
INJECTABLE, TABLET, Injectable

MESNA Approval History

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What MESNA Treats

1 indications

MESNA is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hemorrhagic Cystitis
Source: FDA Label

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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

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.

MESNA FDA Label Details

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Indications & Usage

FDA Label (PDF)

Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Mesna Injection is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. Limitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.

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Data Sources

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