Overview
Fosfomycin was discovered in 1969 by scientists at the Spanish Penicillin and Antibiotics Company and is produced by Streptomyces fradiae. It may also be produced synthetically and is commercially available as the disodium salt for intravenous administration and as the calcium or trometamol salt for oral administration. In terms of chemical structure, fosfomycin is a phosphoenolpyruvate analog and contains a phosphonic group and an epoxide ring. Due to its ease of administration as a single 3-gram oral dose and desirable safety profile, fosfomycin has largely become a first-line therapeutic option for the treatment of uncomplicated urinary tract infections (UTIs) in females. Despite being FDA approved only for urinary tract infections, fosfomycin actually has a broad spectrum of activity and is active against both gram-positive and gram-negative bacteria. As such there is great interest in exploring the usefulness of fosfomycin for indications beyond the treatment of UTIs.
Background
Fosfomycin was discovered in 1969 by scientists at the Spanish Penicillin and Antibiotics Company and is produced by Streptomyces fradiae. It may also be produced synthetically and is commercially available as the disodium salt for intravenous administration and as the calcium or trometamol salt for oral administration. In terms of chemical structure, fosfomycin is a phosphoenolpyruvate analog and contains a phosphonic group and an epoxide ring. Due to its ease of administration as a single 3-gram oral dose and desirable safety profile, fosfomycin has largely become a first-line therapeutic option for the treatment of uncomplicated urinary tract infections (UTIs) in females. Despite being FDA approved only for urinary tract infections, fosfomycin actually has a broad spectrum of activity and is active against both gram-positive and gram-negative bacteria. As such there is great interest in exploring the usefulness of fosfomycin for indications beyond the treatment of UTIs.
Indication
Fosfomycin is indicated for the treatment of uncomplicated cases of cystitis caused by susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin is not officially indicated for the treatment of pyelonephritis or perinephric abscess, although there have been reported cases of off-label usage in these situations.
Associated Conditions
- Complicated Urinary Tract Infection
- Uncomplicated Urinary Tract Infections caused by E. coli
- Uncomplicated Urinary Tract Infections caused by Enterococcus faecalis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/02/07 | N/A | Recruiting | Azienda Ospedaliera di Lecco | ||
2024/10/26 | Phase 4 | Completed | |||
2024/07/24 | Phase 4 | Not yet recruiting | Shalamar Institute of Health Sciences | ||
2024/06/03 | Phase 4 | Recruiting | Clinical Hospital Centre Zagreb | ||
2023/08/30 | Phase 1 | Completed | |||
2023/02/01 | Phase 3 | Recruiting | |||
2022/09/19 | Phase 3 | Completed | Benova (Tianjin) Innovative medicine Research Co., Ltd. | ||
2022/04/05 | Phase 3 | Recruiting | Fundación para la Investigación Biosanitaria del Principado de Asturias | ||
2022/03/02 | N/A | Completed | |||
2022/02/24 | Phase 3 | Terminated | MJM Bonten |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Amneal Pharmaceuticals NY LLC | 60219-3955 | ORAL | 3 g in 1 1 | 4/2/2024 | |
Bryant Ranch Prepack | 63629-9470 | ORAL | 3 g in 1 1 | 9/1/2022 | |
A-S Medication Solutions | 50090-5826 | ORAL | 3 g in 1 1 | 11/11/2020 | |
Cipla USA Inc. | 69097-579 | ORAL | 3 g in 1 1 | 1/28/2022 | |
XIROMED LLC | 70700-268 | ORAL | 3 g in 1 1 | 11/11/2020 | |
A-S Medication Solutions | 50090-6130 | ORAL | 3 g in 1 1 | 9/1/2022 | |
Ascend Laboratories, LLC | 67877-749 | ORAL | 3 g in 1 1 | 9/1/2022 | |
Zambon USA, Ltd | 82036-4274 | ORAL | 3 g in 1 1 | 10/3/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
MONUROL SACHET 3 g/sachet | SIN11013P | GRANULE, FOR SUSPENSION | 3 g/sachet | 7/7/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Fosfomycin Sodium for Injection | 国药准字H20247324 | 化学药品 | 注射剂 | 12/20/2024 | |
Fosfomycin Sodium for Injection | 国药准字H20247323 | 化学药品 | 注射剂 | 12/20/2024 | |
Fosfomycin Sodium for Injection | 国药准字H44023267 | 化学药品 | 注射剂 | 8/14/2020 | |
Fosfomycin Sodium for Injection | 国药准字H20058179 | 化学药品 | 注射剂 | 7/8/2020 | |
Fosfomycin Sodium for Injection | 国药准字H19993360 | 化学药品 | 注射剂 | 3/9/2020 | |
Fosfomycin Sodium for Injection | 国药准字H20013341 | 化学药品 | 注射剂 | 9/23/2020 | |
Fosfomycin Sodium for Injection | 国药准字H43020769 | 化学药品 | 注射剂 | 12/18/2020 | |
Fosfomycin Sodium for Injection | 国药准字H20054163 | 化学药品 | 注射剂(无菌分装粉针剂) | 4/13/2020 | |
Fosfomycin Sodium for Injection | 国药准字H20057067 | 化学药品 | 注射剂 | 7/8/2020 | |
Fosfomycin Sodium for Injection | 国药准字H20053395 | 化学药品 | 注射剂 | 10/23/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |