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Fosfomycin
Monurol (fosfomycin) is a small molecule pharmaceutical. Fosfomycin was first approved as Monurol on 1996-12-19. It is used to treat escherichia coli infections, gram-positive bacterial infections, klebsiella infections, proteus infections, and serratia infections amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Monurol (generic drugs available since 2020-10-06)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosfomycin tromethamine
Tradename
Company
Number
Date
Products
MONUROLZambonN-050717 RX1996-12-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fosfomycin tromethamineANDA2023-02-06
monurolNew Drug Application2019-10-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
escherichia coli infectionsEFO_1001318D004927B96.20
gram-positive bacterial infectionsD016908
klebsiella infectionsEFO_1001353D007710
proteus infectionsEFO_1001130D011512
serratia infectionsEFO_1001421D016868
urinary tract infectionsEFO_0003103D014552N39.0
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01X: Other antibacterials in atc
J01XX: Other antibacterials in atc
J01XX01: Fosfomycin
HCPCS
No data
Clinical
Clinical Trials
44 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary tract infectionsD014552EFO_0003103N39.0458319
CystitisD003556EFO_1000025N30123
InfectionsD007239EFO_0000544112
Asymptomatic diseasesD05807022
EndocarditisD004696EFO_0000465I3311
Prostatic neoplasmsD011471C6111
HospitalizationD00676011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients213
GonorrheaD006069DOID_7551A5411
BacteremiaD016470EFO_0003033R78.8111
PyelonephritisD011704EFO_1001141N10-N16111
Febrile neutropeniaD06414711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AppendicitisD001064EFO_0007149K3722
Bacterial pneumoniaD018410EFO_1001272J15.922
Urinary bladder neoplasmsD001749C6711
Urologic surgical proceduresD01352011
Neonatal sepsisD000071074HP_004018711
PouchitisD019449EFO_0003921K91.850111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pseudomonas infectionsD011552EFO_000107611
Bacterial infectionsD001424A4911
Multiple drug resistanceD01843211
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic diseasesD014570N39.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFOSFOMYCIN
INNfosfomycin
Description
Fosfomycin is a phosphonic acid having an (R,S)-1,2-epoxypropyl group attached to phosphorus. It has a role as an antimicrobial agent and an EC 2.5.1.7 (UDP-N-acetylglucosamine 1-carboxyvinyltransferase) inhibitor. It is an epoxide and a member of phosphonic acids. It is functionally related to a phosphonic acid. It is a conjugate acid of a (1R,2S)-epoxypropylphosphonate(1-).
Classification
Small molecule
Drug classphosphoro-derivatives; antibiotics (Streptomyces strain)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1O[C@@H]1P(=O)(O)O
Identifiers
PDB
CAS-ID23155-02-4
RxCUI4550
ChEMBL IDCHEMBL1757
ChEBI ID28915
PubChem CID446987
DrugBankDB00828
UNII ID2N81MY12TE (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,204 adverse events reported
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