{"id":"fosfomycin-tromethamine-granules","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Vaginitis"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":{"chemblId":"CHEMBL1200331","moleculeType":"Small molecule","molecularWeight":"259.19"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fosfomycin is a broad-spectrum antibiotic that acts as a phosphoenolpyruvate (PEP) analog, irreversibly inhibiting MurA (UDP-N-acetylglucosamine enolpyruvyl transferase), a key enzyme in bacterial peptidoglycan biosynthesis. This disrupts the early stages of cell wall formation, leading to bacterial cell lysis and death. The tromethamine salt formulation enhances solubility and bioavailability for oral administration.","oneSentence":"Fosfomycin inhibits bacterial cell wall synthesis by inactivating the enzyme enolpyruvate transferase, preventing peptidoglycan cross-linking.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:47:04.217Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Uncomplicated urinary tract infections (acute cystitis)"},{"name":"Bacterial infections susceptible to fosfomycin"}]},"trialDetails":[{"nctId":"NCT06822751","phase":"PHASE3","title":"FOsfomycin for Male Urinary Tract Infection","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Rouen","startDate":"2026-03","conditions":"Urinary Tract Infection, Prostatitis, Cystitis","enrollment":138},{"nctId":"NCT05709028","phase":"PHASE3","title":"Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections","status":"RECRUITING","sponsor":"University of Sydney","startDate":"2023-08-02","conditions":"Urinary Tract Infections","enrollment":300},{"nctId":"NCT05545137","phase":"PHASE3","title":"Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection","status":"COMPLETED","sponsor":"Benova (Tianjin) Innovative medicine Research Co., Ltd.","startDate":"2022-09-29","conditions":"Uncomplicated Urinary Tract Infection","enrollment":299},{"nctId":"NCT05254808","phase":"PHASE3","title":"EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care","status":"TERMINATED","sponsor":"MJM Bonten","startDate":"2021-09-06","conditions":"Urinary Tract Infections","enrollment":13},{"nctId":"NCT03151603","phase":"PHASE4","title":"Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial","status":"COMPLETED","sponsor":"University Medical Center Goettingen","startDate":"2017-05-03","conditions":"Urinary Tract Infections","enrollment":398},{"nctId":"NCT02639520","phase":"PHASE3","title":"Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs","status":"COMPLETED","sponsor":"Bionorica SE","startDate":"2015-12","conditions":"Urinary Tract Infection","enrollment":659},{"nctId":"NCT01931592","phase":"PHASE2, PHASE3","title":"Controling Intestinal Colonization With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae ESBL-E","status":"TERMINATED","sponsor":"Maria J.G.T. Vehreschild","startDate":"2014-01","conditions":"Cancer","enrollment":29}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Monurol®"],"phase":"phase_3","status":"active","brandName":"Fosfomycin Tromethamine Granules","genericName":"Fosfomycin Tromethamine Granules","companyName":"Benova (Tianjin) Innovative medicine Research Co., Ltd.","companyId":"benova-tianjin-innovative-medicine-research-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fosfomycin inhibits bacterial cell wall synthesis by inactivating the enzyme enolpyruvate transferase, preventing peptidoglycan cross-linking. Used for Uncomplicated urinary tract infections (acute cystitis), Bacterial infections susceptible to fosfomycin.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}