Clinical Trials

Numerous clinical trials, spanning Early Phase 1 to Phase 4, evaluate the therapeutic utility of fosfomycin for conditions including uncomplicated urinary tract infections, bacterial pneumonia, sepsis, septic shock, and severe Gram-negative infections. Supported by academic investigators, medical institutes, and industry sponsors such as Cardeas Pharma and Benova Innovative Medicine Research, these studies encompass completed, active, terminated, and unknown recruitment statuses. Ultimately, these investigations aim to validate dosing regimens, prophylactic efficacy, and combination strategies for managing drug-resistant bacterial pathogens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06822751 NOT_YET_RECRUITING
Urinary Tract Infection; Prostatitis; Cystitis
University Hospital, Rouen
 2026-07 PHASE3
NCT07004049 RECRUITING
Bloodstream Infection; Ventilator Associated Bacterial Pneumonia; Hospital Acquired Bacterial Pneumonia; Carbapenem Resistant Bacterial Infection; Multidrug Resistance
National University of Singapore
 2025-04-21 PHASE4
NCT07618299 NOT_YET_RECRUITING
Healthy Lactating Women
Meitheal Pharmaceuticals, Inc.
 2026-07 PHASE4
NCT05709028 RECRUITING
Urinary Tract Infections
University of Sydney
 2023-08-02 PHASE3
NCT07557901 ENROLLING_BY_INVITATION
Infectious Complications Following Prostate Biopsy; Prostate Cancer
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
 2026-04-01
NCT07063095 RECRUITING
Gram Negative Infections; Sepsis and Septic Shock
Angela HUTTNER
 2025-08-25 PHASE3
NCT06440304 RECRUITING
Infections, Bacterial; Sepsis Bacterial
Clinical Hospital Centre Zagreb
 2025-01-30 PHASE4
NCT03709914 UNKNOWN
Pediatric ALL
Nabriva Therapeutics AG
 2018-05-24 PHASE1
NCT05055544 UNKNOWN
Cystitis
University of Pecs
 2021-10
NCT06518291 UNKNOWN
Urinary Tract Infections
Shalamar Institute of Health Sciences
 2025-01 PHASE4
NCT06570850 UNKNOWN
Infection Due to Carbapenem Resistant Acinetobacter
Chiang Mai University
 2023-04-01 PHASE4
NCT04959331 COMPLETED
Urinary Tract Infections
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
 2021-11-02 PHASE4
NCT07355907 COMPLETED
Calculi, Renal; PCNL; Infectious Complications
Tanta University
 2023-01-01
NCT07616635 COMPLETED
Haematopoietic Stem Cell Transplantation; Acute Leukemia
Fundación para la Investigación Biosanitaria del Principado de Asturias
 2022-03-14 PHASE3
NCT06017479 COMPLETED
Urological System Complication of Procedure; Urinary Tract Infections
Indonesia University
 2022-12-30 PHASE1; PHASE2
NCT05311254 UNKNOWN
Febrile Neutropenia
Fundación para la Investigación Biosanitaria del Principado de Asturias
 2022-03-14 PHASE3
NCT06659016 COMPLETED
Urinary Tract Infection (Diagnosis)
University of Campania Luigi Vanvitelli
 2023-02-01 PHASE4
NCT05545137 COMPLETED
Uncomplicated Urinary Tract Infection
Benova (Tianjin) Innovative medicine Research Co., Ltd.
 2022-09-29 PHASE3
NCT04979832 UNKNOWN
Pouchitis
Zealand University Hospital
 2021-09-06 PHASE1; PHASE2
NCT04209192 COMPLETED
Urinary Tract Infections; Bladder Cancer; Urologic Surgical Procedures
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2020-01-01 PHASE2
NCT05211011 UNKNOWN
Prosthetic Joint Infection
Charite University, Berlin, Germany
 2018-01-23 PHASE4
NCT04312360 COMPLETED
Right-sided Colon Cancer; Right-sided Colon Adenoma
Zealand University Hospital
 2020-01-16 PHASE2
NCT03959345 TERMINATED
Methicillin Susceptible Staphylococcus Aureus Septicemia
Miquel Pujol
 2019-05-31 PHASE4
NCT05254808 TERMINATED
Urinary Tract Infections
MJM Bonten
 2021-09-06 PHASE3
NCT03228108 COMPLETED
Complication; Infection; Prostate Cancer
Radboud University Medical Center
 2018-04-03 PHASE4
NCT03868969 UNKNOWN
Urinary Tract Infections
Centre Hospitalier Universitaire de Besancon
 2019-04 PHASE2
NCT03910673 COMPLETED
Bacterial Infection; Multiple-drug Resistance; Pathogen Resistance
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-06-27 PHASE1
NCT03950544 UNKNOWN
Antibiotic Resistant Infection
Shanghai 10th People's Hospital
 2019-01-01 EARLY_PHASE1
NCT03294395 COMPLETED
Gonorrhea
Public Health Service of Amsterdam
 2017-09-18 PHASE3
NCT03260010 UNKNOWN
Prosthetic Joint Infection
Pro-Implant Foundation
 2018-01-15 PHASE4
NCT03697993 TERMINATED
Urinary Tract Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-11-07 PHASE4
NCT03151603 COMPLETED
Urinary Tract Infections
University Medical Center Goettingen
 2017-05-03 PHASE4
NCT03453177 COMPLETED
Neonatal SEPSIS
Drugs for Neglected Diseases
 2018-03-15 PHASE2
NCT02142751 COMPLETED
Infection Due to ESBL Escherichia Coli
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2014-07 PHASE3
NCT03435900 COMPLETED
Appendicitis Perforated
Herlev Hospital
 2018-02-14 PHASE2
NCT03548129 UNKNOWN
Urinary Tract Infection
Ain Shams University
 2016-07 PHASE2
NCT01898338 COMPLETED
Staph Aureus Methicillin Resistant Bacteremia
Miquel Pujol
 2013-12 PHASE3
NCT03046758 COMPLETED
Appendicitis
Herlev Hospital
 2017-02-24 PHASE2
NCT03235947 COMPLETED
Urinary Tract Infection; Asymptomatic Bacteriuria
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-09-07 PHASE4
NCT02639520 COMPLETED
Urinary Tract Infection
Bionorica SE
 2015-12 PHASE3
NCT01966653 UNKNOWN
Urinary Tract Infections; Cystitis
University Hospital, Geneva
 2013-10 PHASE4
NCT00976963 COMPLETED
Urinary Tract Infection
University of Washington
 2009-09-17
NCT02570074 COMPLETED
Healthy Subjects
Vance Fowler, M.D.
 2016-01 PHASE1
NCT02709265 COMPLETED
Healthy
Cardeas Pharma
 2016-04 PHASE1
NCT01969799 COMPLETED
Pneumonia, Bacterial
Cardeas Pharma
 2013-12 PHASE2
NCT01803191 COMPLETED
Urinary Tract Infections
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
 2012-08 PHASE4
NCT02218359 WITHDRAWN
Pneumonia, Bacterial
Cardeas Pharma
 2014-10 PHASE2
NCT01820897 COMPLETED
Urinary Tract Infection; Asymptomatic Bacteriuria; Allograft Rejection; Microbiologic Resistance; Hospitalization
JOSE MANUEL ARREOLA GUERRA
 2013-04 PHASE4
NCT02178254 COMPLETED
Pseudomonas Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-08 PHASE1
NCT00871104 COMPLETED
Infective Endocarditis
Juan A. Arnaiz
 2009-07 PHASE4
NCT01488955 COMPLETED
Urinary Tract Infection
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
 2012-02 PHASE4
NCT01297894 UNKNOWN
Drug Safety
Mahidol University
 2010-06 PHASE3
NCT00794586 COMPLETED
Cystic Fibrosis
Gilead Sciences
 2008-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the Fosfomycin Disodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fosfomycin acts by irreversibly inhibiting UDP-N-acetylglucosamine enolpyruvyl transferase (MurA), which blocks the first committed step of bacterial peptidoglycan synthesis and compromises cell wall integrity. This rapid bactericidal cell lysis provides the physiological foundation for its clinical utility in treating urinary tract infections, bacterial pneumonia, and multidrug-resistant Gram-negative bacterial sepsis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.