Drugs / Fosfomycin
Fosfomycin
also known as
fosfomycin-trometamol · ZTI-01 · Monuril · fosfomycin tromethamine · Fosfomycin Calcium · Monural · Monurol · phosphomycin · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pyeloureteritis cystica 1 milestone | |||||
| Filed | US (FDA) | CONTEPO | pyeloureteritis cystica | — | “Meitheal has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for fosfomycin for injection.” meithealpharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | CONTEPO | — | 2025-10-22 | fda.gov ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03950544 | Jan 2019 → Aug 2020 | bacterial infectious disease | Shanghai 10th People's Hospital | Unknown | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT03910673 | Jun 2019 → Dec 2020 | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT03709914 | May 2018 → Dec 2025 | childhood acute lymphoblastic leukemia | Nabriva Therapeutics AG | Unknown | No outcome recorded |
| Phase 1 | NCT03709927 | Jan → Apr 2018 | — | Nabriva Therapeutics AG | Completed | No outcome recorded |
| Phase 1 | NCT02709265 | Apr → Jul 2016 | — | Cardeas Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02570074 | Jan → Sep 2016 | — | Vance Fowler, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT02178254 | Aug → Oct 2014 | Pseudomonas infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/22 trials · 1 missed | ||||||
| Phase 1/2 | NCT06017479 | Dec 2022 → Mar 2024 | urinary tract infection | Indonesia University | Completed | Missed primary |
| Phase 1/2 | NCT04979832 | Sep 2021 → Dec 2023 | pouchitis | Zealand University Hospital | Unknown | No outcome recorded |
| Phase 29 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04312360 | Jan 2020 → Apr 2022 | colon adenoma, malignant colon neoplasm | Zealand University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04209192 | Jan 2020 → Apr 2023 | urinary bladder cancer, urinary tract infection | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | No outcome recorded |
| Phase 2 | NCT03868969 | Apr 2019 → Apr 2021 | urinary tract infection | Centre Hospitalier Universitaire de Besancon | Unknown | No outcome recorded |
| Phase 2 | NCT03453177 | Mar 2018 → Mar 2019 | neonatal sepsis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2 | NCT03435900 | Feb → Jul 2018 | appendicitis | Herlev Hospital | Completed | Met primary |
| Phase 2 | NCT03046758 | Feb → Dec 2017 | appendicitis | Herlev Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02218359 | Oct 2014 → Dec 2015 | bacterial pneumonia | Cardeas Pharma | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01969799 | Dec 2013 → Mar 2016 | bacterial pneumonia | Cardeas Pharma | Completed | Missed primary |
| Phase 2 | NCT00794586 | Nov 2008 → Feb 2010 | cystic fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02753946 | Apr 2016 → Jan 2017 | acute pyelonephritis | Nabriva Therapeutics AG | Completed | Met primary |
| Phase 39 trials · 3 missed | ||||||
| Phase 3 | NCT07686055 | Jul 2026 → Feb 2027 expected | urinary tract infection | Megan Bradley | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07063095 | Aug 2025 → Dec 2026 expected | gram-negative bacterial infections, infectious disease with sepsis | Angela HUTTNER | Recruiting | No outcome recorded |
| Phase 3 | NCT05709028 | Aug 2023 → Aug 2027 expected | urinary tract infection | University of Sydney | Recruiting | No outcome recorded |
| Phase 3 | NCT07616635 | Mar 2022 → May 2024 | acute leukemia, disease related to hematopoietic stem cell transplant | Fundación para la Investigación Biosanitaria del Principado de Asturias | Completed | No outcome recorded |
| Phase 3 | NCT05311254 | Mar 2022 → Mar 2024 | neutropenia | Fundación para la Investigación Biosanitaria del Principado de Asturias | Unknown | Missed primary |
| Phase 3 | NCT05254808 | Sep 2021 → Feb 2022 | urinary tract infection | MJM Bonten | Terminated | No outcome recorded |
| Phase 3 | NCT03294395 | Sep 2017 → Jun 2020 | gonorrhea | Public Health Service of Amsterdam | Completed | Mixed |
| Phase 3 | NCT02142751 | Jul 2014 → Dec 2018 | escherichia coli infection | Andalusian Public Foundation for Health Research in Seville | Completed | Missed primary |
| Phase 3 | NCT01898338 | Dec 2013 → Jan 2018 | methicillin-resistant staphylococcus aureus infectious disease | Miquel Pujol | Completed | Missed primary |
| Phase 412 trials · 2 met primary · 4 missed | ||||||
| Phase 4 | NCT07618299 | Sep 2026 → Sep 2027 expected | — | Meitheal Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT03959345 | May 2019 → Feb 2022 | methicillin-susceptible staphylococcus aureus infectious disease | Miquel Pujol | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT03697993 | Nov 2018 → Oct 2019 | urinary tract infection | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT03228108 | Apr 2018 → Sep 2021 | infectious disease, prostate cancer | Radboud University Medical Center | Completed | Missed primary |
| Phase 4 | NCT05211011 | Jan 2018 → Apr 2022 | periprosthetic joint infection | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 4 | NCT03260010 | Jan 2018 → Apr 2020 | periprosthetic joint infection | Pro-Implant Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT03235947 | Sep 2016 → Nov 2017 | bacteriuria, urinary tract infection | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | Met primary |
| Phase 4 | NCT01820897 | Apr 2013 → Mar 2015 | bacteriuria, transplant rejection, urinary tract infection | JOSE MANUEL ARREOLA GUERRA | Completed | Missed primary |
| Phase 4 | NCT01803191 | Aug 2012 → Jan 2016 | urinary tract infection | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | No outcome recorded |
| Phase 4 | NCT01488955 | Feb 2012 → Feb 2014 | urinary tract infection | Institute of Application-oriented Research and Clinical Trials GmbH | Completed | Mixed |
| Phase 4 | NCT01388413 | Aug 2011 → Jan 2016 | urinary tract infection | University Hospital, Tours | Completed | Met primary |
| Phase 4 | NCT00871104 | Jul 2009 → Jul 2014 | infective endocarditis | Juan A. Arnaiz | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07557901 | Apr 2026 → Apr 2027 expected | prostate cancer | F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica | Enrolling by invitation | No outcome recorded |
| — | NCT00976963 | Sep 2009 → Dec 2016 | urinary tract infection | University of Washington | Completed | No outcome recorded |
| Comparator or background therapy22 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03548129 Comparator | Jul 2016 → Jul 2018 | urinary tract infection | Ain Shams University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01931592 Comparator | Jan 2014 → Oct 2016 | cancer | Maria J.G.T. Vehreschild | Terminated | No outcome recorded |
| 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 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 | Met primary |
| 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 | Mixed |
| Phase 4 | NCT02894684 Background | Jan 2017 → Feb 2019 | Pseudomonas infection, cystic fibrosis | Liverpool Heart and Chest Hospital NHS Foundation Trust | Completed | Met primary |
| 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 | Missed primary |
| — | 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 |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-10-06 | Xiromed LLC | Regulatory Xiromed LLC Announces the First Generic Launch of Fosfomycin Tromethamine Granules for Oral Solution, Generic to Monurol® xiromed.com ↗
Xiromed LLC today announced the approval and launch of Fosfomycin Tromethamine Granules for Oral Solution, the first AA-rated generic version of Monurol® approved by the U.S. Food and Drug Administration. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-18 | Meitheal Pharmaceuticals, Inc. | Meitheal Pharmaceuticals Expands Specialty Biopharmaceuticals Portfolio with Acquisition of CONTEPO™ (Fosfomycin for Injection) from Nabriva Therapeutics meithealpharma.com ↗ |
| 2020-10-06 | Xiromed LLC | Xiromed LLC Announces the First Generic Launch of Fosfomycin Tromethamine Granules for Oral Solution, Generic to Monurol® xiromed.com ↗ |
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 ↗ |
| Known as | Fosfomycin Calcium | “Drug: Fosfomycin Calcium” NCT05311254 ↗ |
| Known as | fosfomycin tromethamine | “Fosfomycin tromethamine sachet (Monurol™) was used in this study.” NCT02570074 ↗1“Drug: Fosfomycin tromethamine” NCT03697993 ↗ |
| 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 | 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 ↗ |