TheraRadar
Data updated: May 26, 2026

MONUROL (fosfomycin tromethamine)

Infectious Disease Approved 1996-12-19
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Discontinued
First Approved
1996-12-19
Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

ZAMBON SPA
Active Ingredient: FOSFOMYCIN TROMETHAMINE

MONUROL Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
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2010
2011
2012
2013
2014
2015
2016
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2018
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2020
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2026
Original
New Indication
New Form
Label Update
9 FDA actions from 1996 to 2018
Nov 2018 SUPPL
Label · Labeling
FDA Letter
May 2018 SUPPL
Label · Labeling
FDA Letter Label
Apr 2011 SUPPL
Label · Labeling
FDA Letter Label

What MONUROL Treats

1 FDA approvals

Originally approved for its first indication in 1996 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03697993 results posted 15-0045 HHSN272201300018I Ph 4 terminated Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)
NCT02178254 13-0064 HHSN272201500005I Ph 1 completed Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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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.

MONUROL FDA Label Details

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Data Sources

FDA Approval: NDA050717 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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