MedPath

Fosfomycin

Generic Name
Fosfomycin
Brand Names
Monurol
Drug Type
Small Molecule
Chemical Formula
C3H7O4P
CAS Number
23155-02-4
Unique Ingredient Identifier
2N81MY12TE

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.
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