fosfomycin

Trade name: monurol

Small moleculeapproved

Approved

Dec 19, 1996

Fosfomycin (marketed under the trade names Monurol and Monuril) is a broad-spectrum antibiotic. Monurol (fosfomycin tromethamine) sachet contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. Monurol is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin is a phosphoenolpyruvate analogue produced by Streptomyces that irreversibly inhibits enolpyruvate transferase (MurA), which prevents the formation of N-acetylmuramic acid, an essential element of the peptidoglycan cell wall. — NCATS

Clinical trial activity

55 trials · 66 clinical orgs · 9 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Nov 1, 2008 (NCT00794586)

Timeline

1990s

Dec 19, 1996
Zambon — Earliest FDA Approval
Dec 19, 1996
Zambon — NDA Organization

2000s

Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
Jan 1, 2009
Earliest Phase 1 Sponsor(trial)

2010s

Jan 1, 2010
Earliest Phase 3 Sponsor(trial)

2020s

Oct 6, 2020
Exeltis — Marketing Organization
Oct 21, 2021
Alkem Labs Ltd — Marketing Organization
Jan 26, 2022
Cipla — Marketing Organization
Mar 25, 2024
Amneal Pharmaceuticals — Marketing Organization
Jun 3, 2025
Precision Dose — Marketing Organization
Oct 22, 2025
Meitheal — Marketing Organization
Nov 14, 2025
Aurobindo Pharma — Marketing Organization
Apr 9, 2026
Aucta Pharms — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

UDP-N-acetylglucosamine 1-carboxyvinyltransferaseINHIBITOR
murA inhibitor
- UDP-N-acetylglucosamine 1-carboxyvinyltransferase (murA) ↗

Approval history

approvedDec 19, 1996

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1O[C@@H]1P(=O)(O)O

Mol. weight: 138.06 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

(-)-(1r,2s)-(1,2-epoxypropyl)phosphonic acid
(-)-(1r,2s)-(1,2-epoxypropyl)phosphonic acid
(1r,2s)-epoxypropylphosphonic acid
(1r,2s)-epoxypropylphosphonic acid
1r-cis-(1,2-epoxypropyl)phosphonic acid
1r-cis-(1,2-epoxypropyl)phosphonic acid
(2r-cis)-(3-methyloxiranyl)phosphonic acid
(2r-cis)-(3-methyloxiranyl)phosphonic acid
cis-(1r,2s)-epoxypropylphosphonic acid
cis-(1r,2s)-epoxypropylphosphonic acid
combination of fosfomycin, metronidazole and rhgm-csf (administered together intraperitoneally) and three days of antibiotics p.o.
fcm
fcm
fosfocina
fosfocina
fosfocina
fosfomicina
fosfomicina
fosfomycin
fosfomycin
fosfomycin
fosfomycin
fosfomycin
fosfomycin
fosfomycin
fosfomycin
fosfomycin calcium
fosfomycin calcium
fosfomycine
fosfomycine
fosfomycin sodium
fosfomycin sodium
fosfomycin trometamol
fosfomycin trometamol
fosfomycin trometamol
fosfomycin trometamol
fosfomycin trometamol
fosfomycin trometamol
fosfomycin trometamol
fosfomycin tromethamine
fosfomycin tromethamine
fosfomycin tromethamine
fosfomycin tromethamine
fosfomycinum
fosfomycinum
l-cis-1,2-epoxypropylphosphonic acid
l-cis-1,2-epoxypropylphosphonic acid
monuril
monuril
monurol
monurol
monurol
phosphomycin
phosphomycin
phosphomycin disodium
phosphonemycin
phosphonemycin
phosphonomycin
phosphonomycin
sodium fosfomycin
z-1282
z-1282

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06822751	Phase 3	Jun 30, 2025	Rouen Normandy University
NCT06518291	Phase 4	Jan 31, 2025	Shalamar Institute of Health Sciences
NCT06756191	Phase 4	Jan 10, 2025	Capital Medical University
NCT06440304	Phase 4	Nov 30, 2024	University of Zagreb
NCT06584006	Phase 2	Sep 1, 2024	Xiamen University
NCT05709028	Phase 3	Aug 2, 2023	University of Sydney
NCT06570850	Phase 4	Apr 1, 2023	Chiangmai University
NCT06659016	Phase 4	Feb 1, 2023	University of Campania Luigi Vanvitelli
NCT06017479	Phase 1/Phase 2 (Phase 2)	Dec 30, 2022	University of Indonesia
NCT05545137	Phase 3	Dec 30, 2022	Greenpine Pharma Group Co.,Ltd., Shandong University
NCT05311254	Phase 3	Mar 14, 2022	Hospital Universitario Central de Asturias, Universidad Carlos III Madrid, University of Cantabria
NCT04959331	Phase 4	Nov 2, 2021	Balearic Islands Health Service (Ibsalut), Gerencia de Atención Primaria, Madrid, Instituto de Investigación Sanitaria Aragón, Jordi Gol i Gurina Foundation
NCT05055544	N/A	Oct 31, 2021	University of Pecs
NCT05254808	Phase 3	Sep 6, 2021	Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development
NCT04979832	Phase 1/Phase 2 (Phase 2)	Sep 6, 2021	University of Copenhagen
NCT05945667	N/A	Jun 7, 2021	PharmaLinea d.o.o.
NCT04285320	Phase 4	Apr 30, 2020	Atlantic Health System
NCT04312360	Phase 2	Jan 16, 2020	Region Zealand, Reponex Pharmaceuticals A/S, University of Copenhagen
NCT04209192	Phase 2	Jan 1, 2020	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Laboratorios Senosiain, S.A. de C.V.
NCT03910673	Phase 1	Jun 13, 2019	National Institute of Allergy and Infectious Diseases (NIAID)

Showing 20 of 55 trials

Page 1 / 3

Organizations

Research & Development (66)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Institute of Allergy and Infectious Diseases (NIAID)	Government	4	3	2	2014
University of Copenhagen	Academic/Hospital	4	4	1	2017
Cardeas Pharma	For profit	3	3	2	2013
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Government	3	3	2	2013
University of Barcelona	Academic/Hospital	3	2	2	2009
Humboldt University	Academic/Hospital	2	1	1	2018
Laboratorios Senosiain, S.A. de C.V.	For profit	2	0	2	2016
Nabriva Therapeutics AG	For profit	2	2	1	2018
Pro-Implant Foundation	Academic/Hospital	2	1	1	2018
Spanish Network for Research in Infectious Diseases	Academic/Hospital	2	1	1	2013
Universidad Carlos III Madrid	Academic/Hospital	2	0	2	2019
ZonMw: The Netherlands Organisation for Health Research and Development	Academic/Hospital	2	0	2	2017
Ain Shams University	Academic/Hospital	1	1	1	2016
Atlantic Health System	Academic/Hospital	1	1	1	2020
Balearic Islands Health Service (Ibsalut)	Academic/Hospital	1	0	1	2021
Bionorica	For profit	1	1	1	2015
Capital Medical University	Academic/Hospital	1	1	1	2025
Chiangmai University	Academic/Hospital	1	1	1	2023
Drugs for Neglected Diseases Initiative	Academic/Hospital	1	1	1	2018
Duke University	Academic/Hospital	1	1	1	2015

66 organizations

Page 1 / 4

Marketing (9)

Organization	Org type	Relationship	Date
Alkem Labs Ltd	For profit	MKTG	Oct 21, 2021
Amneal Pharmaceuticals	For profit	MKTG	Mar 25, 2024
Aucta Pharms	For profit	MKTG	Apr 9, 2026
Aurobindo Pharma	For profit	MKTG	Nov 14, 2025
Cipla	For profit	MKTG	Jan 26, 2022
Exeltis	For profit	MKTG	Oct 6, 2020
Meitheal	For profit	MKTG	Oct 22, 2025
Precision Dose	For profit	MKTG	Jun 3, 2025
Zambon	For profit	NDA	Dec 19, 1996