Fosfomycin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CONTEPO | — | 2025-10-22 | fda.gov ↗ |
Trials 42 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 22 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03548129 Comparator | Jul 2016 → Jul 2018 | urinary tract infection | Ain Shams University | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01931592 Comparator | Jan 2014 → Oct 2016 | cancer | Maria J.G.T. Vehreschild | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05545137 Comparator | Sep 2022 → Feb 2024 | urinary tract infection | Benova (Tianjin) Innovative medicine Research Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01297894 Comparator | Jun 2010 → May 2012 | — | Mahidol University | Unknown | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT07004049 Comparator | Apr 2025 → Dec 2028 expected | bacterial pneumonia, infectious disease with sepsis | National University of Singapore | Recruiting | No outcome recorded |
| Phase 4 | NCT06440304 Comparator | Jan 2025 → Dec 2026 expected | bacterial infectious disease with sepsis | Clinical Hospital Centre Zagreb | Recruiting | No outcome recorded |
| Phase 4 | NCT06518291 Comparator | Jan → Jun 2025 overdue | urinary tract infection | Shalamar Institute of Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06570850 Comparator | Apr 2023 → Mar 2025 overdue | Acinetobacter infectious disease | Chiang Mai University | Recruiting | No outcome recorded |
| Phase 4 | NCT05726318 Background | Feb 2023 → Aug 2024 | urinary tract infection | Megan Bradley | Completed | No outcome recorded |
| Phase 4 | NCT06659016 Comparator | Feb 2023 → Feb 2024 | urinary tract infection | University of Campania Luigi Vanvitelli | Completed | No outcome recorded |
| Phase 4 | NCT05206500 Background | May 2022 → Dec 2028 expected | urinary tract infection | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT04959331 Comparator | Nov 2021 → Dec 2024 | urinary tract infection | Jordi Gol Institute for Primary Care Research | Completed | No outcome recorded |
| Phase 4 | NCT04882085 Comparator | Aug 2021 → Aug 2023 | acute pyelonephritis, bacterial pneumonia, infectious peritonitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT04285320 Comparator | Mar 2021 → Apr 2023 | urinary tract infection | Atlantic Health System | Unknown | No outcome recorded |
| Phase 4 | NCT03151603 Comparator | May 2017 → May 2019 | urinary tract infection | University Medical Center Goettingen | Completed | No outcome recorded |
| Phase 4 | NCT02894684 Background | Jan 2017 → Feb 2019 | Pseudomonas infection, cystic fibrosis | Liverpool Heart and Chest Hospital NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT01966653 Comparator | Oct 2013 → May 2017 | cystitis, urinary tract infection | University Hospital, Geneva | Unknown | No outcome recorded |
| Phase 4 | NCT01039545 Background | Feb 2012 → Dec 2014 | urinary tract infection | Insel Gruppe AG, University Hospital Bern | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05055544 Comparator | Oct 2021 → Oct 2025 | cystitis | University of Pecs | Unknown | No outcome recorded |
| — | NCT05945667 Background | Jun → Dec 2021 | cystitis | PharmaLinea Ltd. | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fosfomycin | “Gilead is developing a broad spectrum combination antibiotic (FTI) consisting of fosfomycin (an antibiotic with activity against gram-positive and gram-negative bacteria) and...” NCT00794586 ↗62“The antibiotics that were chosen (efficient for urinary tract infection, well tolerated, low selection pressure) included : Amoxicillin 6000 mg, Amoxicillin/clavulanic acid...” NCT01388413 ↗ “Given the additional convenience of an available oral formulation - a prerequisite not given for most other ESBL-E active treatments - fosfomycin was chosen for combination...” NCT01931592 ↗ “ZTI-01 (fosfomycin for injection) is an epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis.” PMID 30861061 ↗ Nov 2019 “Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women” NCT07618299 ↗ “main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem” NCT04882085 ↗ “Control group will receive standard therapy, Monural (fosfomycin trometamol) 3 g, at the first day of the trial.” NCT05945667 ↗ “patients will receive intravenous cloxacillin 2g/4h and fosfomycin 3 g/6h for the duration of 7 days treatment.” NCT03959345 ↗ “optional delayed antibiotic treatment with single dose of 3g fosfomycin if deemed necessary by the patient” NCT01039545 ↗ “trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral” NCT07686055 ↗ “14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin” NCT02894684 ↗ “Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach” NCT03548129 ↗ “6) other; fosfomycin. Oral antibiotics” NCT07236944 ↗ “Fosfomycin every 10 days (3 grams)” NCT04285320 ↗ “ZTI-01 (fosfomycin for injection)” NCT03709914 ↗ “fosfomycin 3g once oral” NCT05726318 ↗ “Fosfomycin” NCT02099240 ↗ “Fosfomycin” NCT05206500 ↗ |
| Known as | Fosfomycin Calcium | “Drug: Fosfomycin Calcium” NCT05311254 ↗ |
| Known as | fosfomycin trometamol | “The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections...” NCT03868969 ↗5“Fosfomycin trometamol (Monuril) is approved in numerous countries worldwide, including various European countries and the USA, mainly for the treatment of uncomplicated UTIs” NCT03548129 ↗ “Control group will receive standard therapy, Monural (fosfomycin trometamol) 3 g, at the first day of the trial.” NCT05945667 ↗ “Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.” NCT07557901 ↗ “In the Netherlands, Fosfomycin is orally available as fosfomycin-trometamol (Monuril).” NCT05254808 ↗ “with the option to switch to oral fosfomycin trometamol for the fosfomycin group” PMID 35024838 ↗ Jan 2022 |
| Known as | Fosfomycin tromethamine | “Fosfomycin tromethamine sachet (Monurol™) was used in this study.” NCT02570074 ↗1“Drug: Fosfomycin tromethamine” NCT03697993 ↗ |
| Known as | Monural | “Control group will receive standard therapy, Monural (fosfomycin trometamol) 3 g, at the first day of the trial.” NCT05945667 ↗ |
| Known as | Monuril | “Fosfomycin trometamol (Monuril) is approved in numerous countries worldwide, including various European countries and the USA, mainly for the treatment of uncomplicated UTIs” NCT03548129 ↗2“In the Netherlands, Fosfomycin is orally available as fosfomycin-trometamol (Monuril).” NCT05254808 ↗ “fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0)” NCT03151603 ↗ |
| Known as | Monurol | “Fosfomycin tromethamine sachet (Monurol™) was used in this study.” NCT02570074 ↗ |
| Known as | phosphomycin | “Nature: also known as phosphomycin, phosphonomycin, is a broad-spectrum antibiotic, produced by certain Streptomyces species, although it can now be made by chemical synthesis.” NCT03548129 ↗ |
| Known as | phosphonomycin | “Nature: also known as phosphomycin, phosphonomycin, is a broad-spectrum antibiotic, produced by certain Streptomyces species, although it can now be made by chemical synthesis.” NCT03548129 ↗ |
| Known as | ZTI-01 | “Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women” NCT07618299 ↗ |
| Action | Inhibit | “Fosfomycin (FOS) is a wall antibiotic (pyruvyl-transferase inhibitor)” NCT03235947 ↗ |
| Modality | Small molecule | “Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt.” NCT03910673 ↗ |
| Route | Inhaled | “fosfomycin and tobramycin inhaled twice daily” NCT00794586 ↗ |