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Compound · clinical trials

Fosfomycin clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 3 trials in our Australia, China, Spain, Turkey, Singapore and Italy registers that name Fosfomycin as an intervention. Synced 27 Sep 2026
3Current trials
3Recruiting now
3Lead sponsors
6Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Fosfomycin is named as an intervention in 3 current clinical trials in our Australia, China, Spain, Turkey, Singapore and Italy registers. 3 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is National University of Singapore (1). The most-studied condition is Bloodstream Infection. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.

Where Fosfomycin is approved

All regulators →

Fosfomycin was first approved in Canada on 1 May 2019. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
22 Oct 2025
Contepo
NDA212271 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
1 May 2019
Ivozfo
Notice of Compliance 22103
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Trials by status

  • Recruiting3100%

Trials by phase

  • Phase 4133%
  • Observational133%
  • Phase 3133%
01

Clinical trials of Fosfomycin

3 trials
StudyPhaseStatusLead sponsorRegisters
Optimising TREATment for Severe Gram-Negative Bacterial Infections
NCT07004049 · ClinicalTrials.gov ↗ · Bloodstream Infection, Ventilator Associated Bacterial Pneumonia, Hospital Acquired Bacterial Pneumonia
Phase 4 Recruiting National University of Singapore China, Spain, Turkey, Singapore, Australia
Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections
NCT05709028 · ClinicalTrials.gov ↗ · Urinary Tract Infections
Phase 3 Recruiting University of Sydney Australia
Use of Fosfomycin in the Treatment of Bacterial Infections
NCT06814899 · ClinicalTrials.gov ↗ · Analyze the Medical Records of Patients Admitted At ASST Lecco from 01/04/2020 to 31/12/2023 Treated with Fosfomycin IV
Observational Recruiting Azienda Ospedaliera di Lecco Italy

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Fosfomycin in the EU trials register (CTIS)

3 trials

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Fosfomycin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
FOSFORMEN : Randomized, multicenter, non-inferiority trial comparing the efficacy of fosfomycin versus fluoroquinolones or cotrimoxazole as oral follow-up treatment in febrile urinary tract infections in men caused by susceptible enterobacteria
2026-525972-25-00 · Male Urogenital Diseases
Phase 3 Authorised Assistance Publique Hopitaux De Paris France
Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci
2026-526149-91-00 · CTIS ↗ · Cardiovascular Diseases
Phase 3 Authorised Friedrich-Schiller-Universitaet Jena Germany
Multicentre, randomised, double-blind, placebo-controlled clinical trial to confirm the efficacy, safety, and clinical impact of the mucosal bacterial therapeutic vaccine MV140 in women with non-complicated recurrent urinary tract infections (rUTIs).
2025-524377-16-00 · CTIS ↗ · Bacterial Infections and Mycoses
Phase 3 Authorised Inmunotek S.L Portugal
03

Fosfomycin across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Fosfomycin on the HPRA medicines list.

All 1 Irish product →

Supply shortages

No entry for Fosfomycin in the EMA, FDA or German BfArM shortage lists we track.

04

Conditions studied with Fosfomycin

6 conditions
Bloodstream Infection1Ventilator Associated Bacterial Pneumonia1Hospital Acquired Bacterial Pneumonia1Carbapenem Resistant Bacterial Infection1Analyze the Medical Records of Patients Admitted At ASST Lecco from 01/04/2020 to 31/12/2023 Treated with Fosfomycin IV1Urinary Tract Infections1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
National University of Singapore1
Azienda Ospedaliera di Lecco1
University of Sydney1
06

By country register

RegisterTrialsRecruiting
Clinical trials in Australia22
Clinical trials in China11
Clinical trials in Spain11
Clinical trials in Turkey11
Clinical trials in Singapore11
Clinical trials in Italy11
EU register (CTIS)3—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Fosfomycin trials

How many clinical trials are testing Fosfomycin?

3 current trials in our Australia, China, Spain, Turkey, Singapore and Italy registers name Fosfomycin as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Fosfomycin trials recruiting patients?

Yes. 3 of the 3 trials are recruiting: 2 with sites in Australia, 1 with sites in China, 1 with sites in Spain, 1 with sites in Turkey, 1 with sites in Singapore and 1 with sites in Italy. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Fosfomycin clinical trials?

National University of Singapore (1), Azienda Ospedaliera di Lecco (1) and University of Sydney (1). The number in brackets is how many trials each organisation leads.

Is Fosfomycin licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Fosfomycin, for example Fomicyt 40 mg/ml Powder for solution for infusion (InfectoPharm Arzneimittel und Consilium GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Fosfomycin shortage?

Not in the lists we track: Fosfomycin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Fosfomycin works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Fosfomycin works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Fosfomycin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.