Fosfomycin tromethamine
Fosfomycin Tromethamine (fosfomycin tromethamine) is a small molecule pharmaceutical. Fosfomycin tromethamine 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
Fosfomycin tromethamine (discontinued: Monurol)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fosfomycin tromethamine | ANDA | 2025-03-17 |
Indications
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EMA
Agency Specific
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Clinical
Clinical Trials
85 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 | 1 | 6 | 6 | 15 | 7 | 33 |
| Infections | D007239 | EFO_0000544 | — | — | 3 | 5 | 13 | 9 | 29 |
| Communicable diseases | D003141 | — | — | — | 2 | 4 | 9 | 7 | 21 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 2 | 2 | 3 | 3 | 9 |
| Bacterial infections | D001424 | — | A49 | 1 | — | — | 2 | 5 | 8 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 2 | — | 1 | 3 | 7 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | 2 | 4 | 7 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | — | 2 | 2 | 3 | 7 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 2 | — | 1 | 1 | 4 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | 2 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gram-negative bacterial infections | D016905 | — | — | — | — | 1 | — | 3 | 4 |
| Neutropenia | D009503 | — | D70 | — | 1 | 2 | — | 1 | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | 1 | — | — | 3 |
| Escherichia coli infections | D004927 | EFO_1001318 | B96.20 | — | — | 1 | — | 1 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 1 | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 1 | — | 1 | 2 |
| Gonorrhea | D006069 | DOID_7551 | A54 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 1 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | — | 1 | — | — | 1 |
Show 6 more
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 |
| Toxemia | D014115 | — | — | — | 1 | — | — | 1 | 2 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Urologic surgical procedures | D013520 | — | — | — | 1 | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | — | 1 | — | — | — | 1 |
| Adenoma | D000236 | — | — | — | 1 | — | — | — | 1 |
| Neonatal sepsis | D000071074 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | 1 | 2 |
| Disease resistance | D060467 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Staphylococcal infections | D013203 | — | A49.01 | — | — | — | — | 3 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 2 | 2 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 2 | 2 |
| Hypokalemia | D007008 | — | E87.6 | — | — | — | — | 2 | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fosfomycin tromethamine |
| INN | — |
| 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.NC(CO)(CO)CO |
Identifiers
| PDB | — |
| CAS-ID | 23155-02-4 |
| RxCUI | 4550 |
| ChEMBL ID | CHEMBL1200331 |
| ChEBI ID | — |
| PubChem CID | 446987 |
| DrugBank | DB00828 |
| UNII ID | — |
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Safety
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Adverse Events
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1,024 adverse events reported
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