{"id":"prulifloxacin","rwe":[{"pmid":"41468662","year":"2026","title":"Chiral separation of fluoroquinolones by capillary electrophoresis using glucosamine-functionalized carbon quantum dots as a Pseudostationary phase.","finding":"","journal":"Journal of chromatography. B, Analytical technologies in the biomedical and life sciences","studyType":"Clinical Study"},{"pmid":"40784488","year":"2025","title":"In vitro inhibition effect of various pharmacologically relevant drugs on recombinant paraoxonase 1.","finding":"","journal":"Chemico-biological interactions","studyType":"Clinical Study"},{"pmid":"40495004","year":"2025","title":"Structural insight in understanding the impact of mutation at position 88 and 94 of DNA gyrase A of Mycobacterium tuberculosis in developing resistance against delafloxacin.","finding":"","journal":"Journal of biological physics","studyType":"Clinical Study"},{"pmid":"40261681","year":"2025","title":"Medoxomil Prodrug Strategies.","finding":"","journal":"Journal of medicinal chemistry","studyType":"Clinical Study"},{"pmid":"39875945","year":"2025","title":"Comparison of treatments for preventing lower urinary tract symptoms after BCG immunotherapy of bladder tumors : a systematic review and network meta-analysis.","finding":"","journal":"BMC urology","studyType":"Clinical Study"}],"tags":[{"label":"prulifloxacin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01MA17","category":"atc"},{"label":"Active","category":"status"},{"label":"Acute exacerbation of chronic bronchitis","category":"indication"},{"label":"Lower urinary tract infectious disease","category":"indication"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Topoisomerase II Inhibitors","category":"pharmacology"},{"label":"Topoisomerase Inhibitors","category":"pharmacology"}],"phase":"phase_3","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":["prulifloxacin","NM441"],"offLabel":[],"synonyms":["prulifloxacin","NM441"],"timeline":[],"approvals":[],"ecosystem":[{"indication":"Acute exacerbation of chronic bronchitis","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefditoren pivoxil","slug":"cefditoren-pivoxil","company":"Vansen Pharma"}],"globalPrevalence":null},{"indication":"Lower urinary tract infectious disease","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"prulifloxacin","explanation":"Imagine your body's cells are like factories that make copies of themselves. Bacteria are like tiny factories that make copies of themselves too, but they can be bad for you. Prulifloxacin stops these bacterial factories from making copies of themselves by blocking the machines that help them replicate their DNA.","oneSentence":"Prulifloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication.","technicalDetail":"Prulifloxacin exerts its antibacterial effects by competitively inhibiting the ATP-binding sites of DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2325","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PRULIFLOXACIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PRULIFLOXACIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:31:13.605163","biosimilars":[],"competitors":[{"drugName":"ofloxacin","drugSlug":"ofloxacin","fdaApproval":"1990-12-28","genericCount":20,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ciprofloxacin","drugSlug":"ciprofloxacin","fdaApproval":"1987-10-22","patentExpiry":"Nov 27, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"enoxacin","drugSlug":"enoxacin","fdaApproval":"1991-12-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"norfloxacin","drugSlug":"norfloxacin","fdaApproval":"1986-10-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"lomefloxacin","drugSlug":"lomefloxacin","fdaApproval":"1992-02-21","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"sparfloxacin","drugSlug":"sparfloxacin","fdaApproval":"1996-12-19","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"grepafloxacin","drugSlug":"grepafloxacin","fdaApproval":"1997-11-06","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"levofloxacin","drugSlug":"levofloxacin","fdaApproval":"1996-12-20","genericCount":36,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"trovafloxacin","drugSlug":"trovafloxacin","fdaApproval":"1997-12-18","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"moxifloxacin","drugSlug":"moxifloxacin","fdaApproval":"1999-12-10","patentExpiry":"May 29, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"gemifloxacin","drugSlug":"gemifloxacin","fdaApproval":"2003-04-04","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"gatifloxacin","drugSlug":"gatifloxacin","fdaApproval":"2003-03-28","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"delafloxacin","drugSlug":"delafloxacin","fdaApproval":"2017-06-19","patentExpiry":"Sep 23, 2029","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"prulifloxacin","indications":{"approved":[{"name":"Acute exacerbation of chronic bronchitis","source":"DrugCentral","snomedId":425748003,"regulator":"FDA"},{"name":"Lower urinary tract infectious disease","source":"DrugCentral","snomedId":4009004,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"ofloxacin","brandName":"ofloxacin","genericName":"ofloxacin","approvalYear":"1990","relationship":"same-class"},{"drugId":"ciprofloxacin","brandName":"ciprofloxacin","genericName":"ciprofloxacin","approvalYear":"1987","relationship":"same-class"},{"drugId":"enoxacin","brandName":"enoxacin","genericName":"enoxacin","approvalYear":"1991","relationship":"same-class"},{"drugId":"norfloxacin","brandName":"norfloxacin","genericName":"norfloxacin","approvalYear":"1986","relationship":"same-class"},{"drugId":"lomefloxacin","brandName":"lomefloxacin","genericName":"lomefloxacin","approvalYear":"1992","relationship":"same-class"},{"drugId":"sparfloxacin","brandName":"sparfloxacin","genericName":"sparfloxacin","approvalYear":"1996","relationship":"same-class"},{"drugId":"grepafloxacin","brandName":"grepafloxacin","genericName":"grepafloxacin","approvalYear":"1997","relationship":"same-class"},{"drugId":"levofloxacin","brandName":"levofloxacin","genericName":"levofloxacin","approvalYear":"1996","relationship":"same-class"},{"drugId":"trovafloxacin","brandName":"trovafloxacin","genericName":"trovafloxacin","approvalYear":"1997","relationship":"same-class"},{"drugId":"moxifloxacin","brandName":"moxifloxacin","genericName":"moxifloxacin","approvalYear":"1999","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01710488","phase":"PHASE4","title":"Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD","status":"COMPLETED","sponsor":"Fadoi Foundation, Italy","startDate":"2009-05","conditions":["COPD Exacerbation"],"enrollment":258,"completionDate":"2013-11"},{"nctId":"NCT03201796","phase":"PHASE2","title":"Prulifloxacin in Chronic Bacterial Prostatitis (CBP)","status":"COMPLETED","sponsor":"Aziende Chimiche Riunite Angelini Francesco S.p.A","startDate":"2016-02-02","conditions":["Chronic Bacterial Prostatitis"],"enrollment":168,"completionDate":"2020-05-19"},{"nctId":"NCT02439632","phase":"PHASE3","title":"A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control","status":"COMPLETED","sponsor":"Lee's Pharmaceutical Limited","startDate":"2014-02","conditions":["Acute Lower Urinary Tract Infection"],"enrollment":216,"completionDate":"2015-07"},{"nctId":"NCT00392574","phase":"PHASE3","title":"Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-08","conditions":["Acute Gastroenteritis in Adult Travelers"],"enrollment":282,"completionDate":"2008-03"},{"nctId":"NCT02157571","phase":"PHASE3","title":"A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control","status":"UNKNOWN","sponsor":"Lee's Pharmaceutical Limited","startDate":"2013-06","conditions":["Acute Exacerbations of Chronic Bronchitis"],"enrollment":360,"completionDate":"2014-09"},{"nctId":"NCT02130713","phase":"PHASE4","title":"Treatment of Chronic Bacterial Prostatitis","status":"COMPLETED","sponsor":"University of Roma La Sapienza","startDate":"2012-01","conditions":["Chronic Bacterial Prostatitis"],"enrollment":210,"completionDate":"2013-01"},{"nctId":"NCT01231737","phase":"PHASE2","title":"Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)","status":"UNKNOWN","sponsor":"University Of Perugia","startDate":"2010-11","conditions":["Urinary Tract Infection"],"enrollment":96,"completionDate":"2012-02"},{"nctId":"NCT00448422","phase":"PHASE3","title":"Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers","status":"COMPLETED","sponsor":"Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","startDate":"2006-12","conditions":["Acute Bacterial Gastroenteritis"],"enrollment":268,"completionDate":"2008-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"015857","UNII":"J42298IESW","CHEBI":"CHEBI:32071","INN_ID":"7249","UMLSCUI":"C0527129","ChEMBL_ID":"CHEMBL422648","KEGG_DRUG":"D01144","DRUGBANK_ID":"DB11892","PUBCHEM_CID":"65947","SNOMEDCT_US":"703590007","SECONDARY_CAS_RN":"112984-60-8","MESH_SUPPLEMENTAL_RECORD_UI":"C074191"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":157,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J01MA17","allCodes":["J01MA17"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Feb 1","pmid":"41468662","title":"Chiral separation of fluoroquinolones by capillary electrophoresis using glucosamine-functionalized carbon quantum dots as a Pseudostationary phase.","journal":"Journal of chromatography. B, Analytical technologies in the biomedical and life sciences"},{"date":"2025 Oct 22","pmid":"40784488","title":"In vitro inhibition effect of various pharmacologically relevant drugs on recombinant paraoxonase 1.","journal":"Chemico-biological interactions"},{"date":"2025 Jun 10","pmid":"40495004","title":"Structural insight in understanding the impact of mutation at position 88 and 94 of DNA gyrase A of Mycobacterium tuberculosis in developing resistance against delafloxacin.","journal":"Journal of biological physics"},{"date":"2025 May 8","pmid":"40261681","title":"Medoxomil Prodrug Strategies.","journal":"Journal of medicinal chemistry"},{"date":"2025 Jan 29","pmid":"39875945","title":"Comparison of treatments for preventing lower urinary tract symptoms after BCG immunotherapy of bladder tumors : a systematic review and network meta-analysis.","journal":"BMC urology"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"PRULIFLOXACIN","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Prulifloxacin is a small molecule that inhibits bacterial DNA gyrase, a mechanism consistent with its classification as a third-generation fluoroquinolone. It has been studied for the treatment of various urinary tract infections, including urinary tract infection, acute lower urinary tract infection, and chronic bacterial prostatitis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}