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 |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
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 |
|---|---|---|---|---|
| MONUROL | Zambon | N-050717 RX | 1996-12-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fosfomycin tromethamine | ANDA | 2023-02-06 |
| monurol | New Drug Application | 2019-10-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
| gram-positive bacterial infections | — | D016908 | — |
| klebsiella infections | EFO_1001353 | D007710 | — |
| proteus infections | EFO_1001130 | D011512 | — |
| serratia infections | EFO_1001421 | D016868 | — |
| urinary tract infections | EFO_0003103 | D014552 | N39.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
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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 infections | D014552 | EFO_0003103 | N39.0 | — | 4 | 5 | 8 | 3 | 19 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | — | — | 1 | 2 | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | 2 | |
| Asymptomatic diseases | D058070 | — | — | — | 2 | — | 2 | ||
| Endocarditis | D004696 | EFO_0000465 | I33 | — | — | — | 1 | — | 1 |
| Prostatic neoplasms | D011471 | C61 | — | — | — | 1 | — | 1 | |
| Hospitalization | D006760 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | 1 | — | — | 3 | ||
| Gonorrhea | D006069 | DOID_7551 | A54 | — | — | 1 | — | — | 1 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | — | 1 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | 1 | — | — | 1 |
| Febrile neutropenia | D064147 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Appendicitis | D001064 | EFO_0007149 | K37 | — | 2 | — | — | — | 2 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 2 | — | — | — | 2 |
| Urinary bladder neoplasms | D001749 | C67 | — | 1 | — | — | — | 1 | |
| Urologic surgical procedures | D013520 | — | 1 | — | — | — | 1 | ||
| Neonatal sepsis | D000071074 | HP_0040187 | — | 1 | — | — | — | 1 | |
| Pouchitis | D019449 | EFO_0003921 | K91.850 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pseudomonas infections | D011552 | EFO_0001076 | 1 | — | — | — | — | 1 | |
| Bacterial infections | D001424 | A49 | 1 | — | — | — | — | 1 | |
| Multiple drug resistance | D018432 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOSFOMYCIN |
| INN | fosfomycin |
| 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 class | phosphoro-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-ID | 23155-02-4 |
| RxCUI | 4550 |
| ChEMBL ID | CHEMBL1757 |
| ChEBI ID | 28915 |
| PubChem CID | 446987 |
| DrugBank | DB00828 |
| UNII ID | 2N81MY12TE (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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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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