Fosfomycin tromethamine
Monurol (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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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
No data
HCPCS
No data
Clinical
Clinical Trials
173 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | HP_0002013 | R11.1 | 8 | 20 | 23 | 10 | 10 | 70 |
| Nausea | D009325 | HP_0002018 | R11.0 | 2 | 12 | 6 | 6 | 5 | 31 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | 2 | 2 | 3 | 12 | 7 | 25 | |
| Neoplasms | D009369 | C80 | 2 | 2 | 2 | 2 | 3 | 10 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | 3 | 2 | 1 | 8 |
| Lymphoma | D008223 | C85.9 | — | 1 | — | 2 | 3 | 6 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | 1 | 3 | 5 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 2 | — | 1 | 1 | 4 |
| Healthy volunteers/patients | — | 3 | — | — | 1 | — | 4 | ||
| Leukemia | D007938 | C95 | — | — | — | 2 | 2 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | 9 | — | — | 9 |
| Non-small-cell lung carcinoma | D002289 | — | 2 | 1 | — | 1 | 4 | ||
| Myeloproliferative disorders | D009196 | D47.1 | — | — | 1 | — | 2 | 3 | |
| Myeloid leukemia acute | D015470 | C92.0 | — | 2 | 1 | — | — | 3 | |
| Colorectal neoplasms | D015179 | — | 1 | 1 | — | 1 | 3 | ||
| Multiple myeloma | D009101 | C90.0 | 1 | 1 | 1 | — | — | 3 | |
| Gastrointestinal neoplasms | D005770 | C26.9 | — | — | 1 | — | 1 | 2 | |
| Female genital neoplasms | D005833 | — | — | 1 | — | — | 1 | ||
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | — | — | 1 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 3 | — | — | — | 3 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | 1 | 2 | — | — | — | 3 |
| Myelodysplastic syndromes | D009190 | D46 | — | 1 | — | — | 2 | 3 | |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | 1 | 2 |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | — | 1 | |
| Analgesia | D000698 | — | 1 | — | — | — | 1 | ||
| Head and neck neoplasms | D006258 | — | 1 | — | — | — | 1 | ||
| Glioblastoma | D005909 | EFO_0000515 | 1 | 1 | — | — | — | 1 | |
| Lung neoplasms | D008175 | C34.90 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | — | — | — | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 2 | — | — | — | — | 2 |
| Tobacco use disorder | D014029 | F17 | 1 | — | — | — | — | 1 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Heroin dependence | D006556 | EFO_0004240 | 1 | — | — | — | — | 1 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 2 | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | — | 2 | 2 | ||
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
| Genetic polymorphism | D011110 | — | — | — | — | 1 | 1 | ||
| Brenner tumor | D001948 | — | — | — | — | 1 | 1 | ||
| Endometrioid carcinoma | D018269 | — | — | — | — | 1 | 1 | ||
| Fallopian tube neoplasms | D005185 | — | — | — | — | 1 | 1 | ||
| Cystadenocarcinoma | D003536 | — | — | — | — | 1 | 1 | ||
| Narcotic-related disorders | D000079524 | — | — | — | — | 1 | 1 | ||
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOSFOMYCIN TROMETHAMINE |
| 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.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 | 2N81MY12TE (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,899 adverse events reported
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