TheraRadar
Data updated: Jun 28, 2026

MONUROL (fosfomycin tromethamine) · ZAMBON SPA

Infectious Disease Approved 1996-12-19

MONUROL is FDA-approved to treat 3 conditions (same as FOSFOMYCIN TROMETHAMINE).

Source: FDA Label
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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
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

3 indications

MONUROL is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as FOSFOMYCIN TROMETHAMINE (same active ingredient).

Source: FDA Label
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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

Indications & Usage

FDA Label (PDF)

MONUROL is FDA-approved to treat 3 conditions — same approved indications as FOSFOMYCIN TROMETHAMINE.

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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.