Monurol

(Fosfomycin)

ApprovedSmall molecule

Fosfomycin is an antibiotic used to treat urinary tract infections, particularly uncomplicated bladder infections (cystitis) in women. It works by killing bacteria that cause these infections.[2] Monurol is currently approved and in use across 10 indications[4].[1]

Monurol is one of 118 small molecule programs targeting Bacterial Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

117

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

PouchitisApproved

Pseudomonas InfectionApproved

AppendicitisApproved

Childhood Acute Lymphoblastic LeukemiaApproved

Neonatal SepsisApproved

OsteomyelitisApproved

Urinary Tract InfectionRecruiting

Recurrent Urinary Tract InfectionsCompleted

CystitisTerminated

Bacterial DiseaseApproved

Active, not recruiting

PouchitisApproved

Approved

Pseudomonas InfectionApproved

Approved

AppendicitisApproved

Approved

Childhood Acute Lymphoblastic LeukemiaApproved

Approved

Neonatal SepsisApproved

Approved

OsteomyelitisApproved

Approved

Urinary Tract InfectionApproved

Recruiting

Recurrent Urinary Tract InfectionsApproved

Completed

CystitisApproved

Terminated

Competition

Competitive Landscape

43 competitors in Bacterial Disease

#DrugCompanyPhaseTrials

Monurol

MMeitheal

Approved

21 2

Biaxin

Cipro

Aralen

Maxipime

Avelox

Doribax

Keflex

Ketek

Dalvance

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Study completion

NCT06440304

Q3 2027

Phase 3Recruiting

Urinary Tract Infection

NCT05709028

Clinical

Trials by Indication[1]

Urinary Tract Infection4 trials

Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial

Completed·UUniversity Medical Center Goettingen·Phase 4·NCT03151603·398 enrolled

Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections

Recruiting·UUniversity of Sydney·Phase 3·NCT05709028·300 enrolled

Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women

Unknown status·UUniversity Hospital, Geneva·Phase 4·NCT01966653·600 enrolled

Show 1 more trial

Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)

Unknown status·—·Phase 2·NCT03868969·25 enrolled

Cystitis4 trials

Single Dose Monurol for Treatment of Acute Cystitis

Completed·UUniversity of Washington·N/A·NCT00976963·300 enrolled

EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care

Terminated·MMJM Bonten·Phase 3·NCT05254808·13 enrolled

Bearberry in the Treatment of Cystitis

Unknown status·UUniversity of Pecs·N/A·NCT05055544·504 enrolled

Show 1 more trial

COMPARISON OF NITROFURANTOIN WITH FOSFOMYCIN in TREATING CYSTITIS IN WOMEN

Not yet recruiting·—·Phase 4·NCT06518291·392 enrolled

Prosthetic-joint Infection2 trials

Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection

Unknown status·PPro-Implant Foundation·Phase 4·NCT03260010·224 enrolled

Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection

Unknown status·—·Phase 4·NCT05211011·226 enrolled

Bacterial Infections1 trial

Use of Fosfomycin in the Treatment of Bacterial Infections

Recruiting·AAzienda Ospedaliera di Lecco··NCT06814899·300 enrolled

Prophylaxis1 trial

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

Completed·RRadboud University Medical Center·Phase 4·NCT03228108·1,538 enrolled

7 more indications

Adult1 trial

PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults

Completed·—·Phase 1·NCT02570074·19 enrolled

Pneumonia1 trial

The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Unknown status·SShanghai 10th People's Hospital·Phase 1·NCT03950544·80 enrolled

Antibiotic1 trial

New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

Completed·PPublic Health Service of Amsterdam·Phase 3·NCT03294395·346 enrolled

Ciprofloxacin1 trial

Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

Completed·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 4·NCT01803191·461 enrolled

Recurrent urinary tract infections1 trial

Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT06659016·148 enrolled

Effectiveness1 trial

Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention

Completed·IIndonesia University·Phase 1/2·NCT06017479·126 enrolled

Unspecified3 trials

Observational Follow-up Study of REGATTA

Completed·UUniversity Medical Center Goettingen··NCT03176563·398 enrolled

Therapeutic Options for CRAB

Recruiting·—·Phase 4·NCT06440304·108 enrolled

Effect of Cranberry Extract on the Urinary System

Completed·—··NCT05260554·2 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 22, 2025

CONTEPO

NDA NDA212271

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Fosfomycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Monurol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fosfomycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fosfomycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212271). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Monurol. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Meitheal company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: UDP-N-Acetylglucosamine 1-Carboxyvinyltransferase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMeitheal

Patent Landscape[6]

Patent Cliff

Oct 12, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10086006Oct 12, 2034

9345717Oct 27, 2034

12702676Jan 30, 2039

11541064Jan 30, 2039

Monurol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Trials by Indication[1]

Urinary Tract Infection4 trials

Cystitis4 trials

Prosthetic-joint Infection2 trials

Bacterial Infections1 trial

Prophylaxis1 trial

Adult1 trial

Pneumonia1 trial

Antibiotic1 trial

Ciprofloxacin1 trial

Recurrent urinary tract infections1 trial

Effectiveness1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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