{"id":"sitafloxacin","rwe":[{"pmid":"41887154","year":"2026","title":"Killing of stationary staphylococcus aureus within microaggregates and macrophages by free sitafloxacin and sugar, or as carrier-free nanodrug.","finding":"","journal":"Colloids and surfaces. B, Biointerfaces","studyType":"Clinical Study"},{"pmid":"41834726","year":"2026","title":"Successful treatment with clofazimine for macrolide-resistant Mycobacterium abscessus infection in a peritoneal dialysis patient: A case report and literature review.","finding":"","journal":"Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis","studyType":"Clinical Study"},{"pmid":"41783235","year":"2026","title":"Effects of hydroxybisphosphonates-conjugated sitafloxacin on fracture healing and skeletal growth in mice.","finding":"","journal":"JBMR plus","studyType":"Clinical Study"},{"pmid":"41770319","year":"2026","title":"[Superbugs Neisseria gonorrhoeae und Mycoplasma genitalium : Therapeutic challenges driven by antimicrobial resistance].","finding":"","journal":"Dermatologie (Heidelberg, Germany)","studyType":"Clinical Study"},{"pmid":"41657899","year":"2026","title":"A single-center culture-based study of Helicobacter pylori in Kazakhstan with regional meta-analysis of prevalence and antibiotic resistance.","finding":"","journal":"Frontiers in microbiology","studyType":"Clinical Study"}],"tags":[{"label":"sitafloxacin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01MA21","category":"atc"},{"label":"Active","category":"status"},{"label":"Respiratory tract infection","category":"indication"},{"label":"Urinary tract infectious disease","category":"indication"},{"label":"Daiichi Sankyo","category":"company"},{"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":"marketed","safety":{},"trials":[],"aliases":[],"company":"Daiichi Sankyo","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SITAFLOXACIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:54:32.721309+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:54:38.364054+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SITAFLOXACIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:54:38.902835+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Topoisomerase IV inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:54:39.982128+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989504/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:54:39.612246+00:00"}},"allNames":"gracevit","offLabel":[],"synonyms":["DU-6859a","sitafloxacin sesquihydrate","sitafloxacin","gracevit","sitafloxacin hydrate","DU-6859"],"timeline":[{"date":"2008-01-25","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Daiichi Sankyo)"}],"approvals":[{"date":"2008-01-25","orphan":false,"company":"Daiichi Sankyo","regulator":"PMDA"}],"brandName":"Gracevit","ecosystem":[{"indication":"Respiratory tract infection","otherDrugs":[],"globalPrevalence":890552},{"indication":"Urinary tract infectious disease","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"acetohydroxamic acid","slug":"acetohydroxamic-acid","company":"Mission Pharma"},{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"sitafloxacin","explanation":"","oneSentence":"","technicalDetail":"Sitafloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription, thereby preventing bacterial DNA replication and transcription, and ultimately leading to bacterial cell death."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2449","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SITAFLOXACIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SITAFLOXACIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:38:01.324983","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:54:41.362391+00:00","fieldsConflicting":1,"overallConfidence":0.8},"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":"sitafloxacin","indications":{"approved":[{"name":"Respiratory tract infection","source":"DrugCentral","snomedId":275498002,"regulator":"FDA","usPrevalence":null,"globalPrevalence":890552,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (ORPHANET)"},{"name":"Urinary tract infectious disease","source":"DrugCentral","snomedId":68566005,"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":"NCT06905522","phase":"PHASE3","title":"A PAN-USR TB Multi-Center Trial","status":"RECRUITING","sponsor":"Shenzhen Third People's Hospital","startDate":"2025-06-18","conditions":["Pulmonary Tuberculosis"],"enrollment":610,"completionDate":"2029-12"},{"nctId":"NCT07076225","phase":"PHASE3","title":"Ultra-Short Regimen for Elderly DS-TB","status":"NOT_YET_RECRUITING","sponsor":"Shenzhen Third People's Hospital","startDate":"2025-07-25","conditions":["Pulmonary Tuberculosis"],"enrollment":300,"completionDate":"2030-07-31"},{"nctId":"NCT06809413","phase":"PHASE2","title":"Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease","status":"ENROLLING_BY_INVITATION","sponsor":"Beijing Chest Hospital","startDate":"2025-01-28","conditions":["Fluoroquinolone","Mycobacterium"],"enrollment":12,"completionDate":"2025-05-31"},{"nctId":"NCT05400369","phase":"PHASE4","title":"A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2022-08-10","conditions":["COPD Exacerbation Acute"],"enrollment":140,"completionDate":"2024-09-25"},{"nctId":"NCT02729116","phase":"PHASE2,PHASE3","title":"Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients","status":"UNKNOWN","sponsor":"Khon Kaen University","startDate":"2016-07","conditions":["Anti-Infective Agents, Urinary","Escherichia Coli Infections","Klebsiella Infections","Kidney Transplantation","Urinary Tract Infections"],"enrollment":30,"completionDate":"2024-01"},{"nctId":"NCT05454345","phase":"PHASE3","title":"Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2022-10-01","conditions":["Tuberculosis, Pulmonary"],"enrollment":620,"completionDate":"2026-06-30"},{"nctId":"NCT05313750","phase":"PHASE4","title":"Efficacy and Safety of Sitafloxacin in the Treatment of Acute Exacerbation of Bronchiectasis in Adults","status":"UNKNOWN","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2021-06-30","conditions":["Acute Exacerbation of Bronchiectasis"],"enrollment":256,"completionDate":"2024-06-30"},{"nctId":"NCT02537847","phase":"PHASE2","title":"Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli","status":"UNKNOWN","sponsor":"Mahidol University","startDate":"2012-11","conditions":["Infection Due to Escherichia Coli","Acute Pyelonephritis"],"enrollment":96,"completionDate":"2016-05"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"9TD681796G","CHEBI":"CHEBI:4304","UMLSCUI":"C0171447","chemblId":"CHEMBL3989504","ChEMBL_ID":"CHEMBL3989504","KEGG_DRUG":"D02475","DRUGBANK_ID":"DB13261","PUBCHEM_CID":"461399","IUPHAR_LIGAND_ID":"11040","SECONDARY_CAS_RN":"163253-35-8","MESH_SUPPLEMENTAL_RECORD_UI":"C076246"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Daiichi Sankyo","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"6.6 hours","clearance":"3.7 mL/min/kg","bioavailability":"89%","fractionUnbound":"0.51%","volumeOfDistribution":"1.5 L/kg"},"publicationCount":400,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J01MA21","allCodes":["J01MA21"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 24","pmid":"41887154","title":"Killing of stationary staphylococcus aureus within microaggregates and macrophages by free sitafloxacin and sugar, or as carrier-free nanodrug.","journal":"Colloids and surfaces. B, Biointerfaces"},{"date":"2026 Mar 16","pmid":"41834726","title":"Successful treatment with clofazimine for macrolide-resistant Mycobacterium abscessus infection in a peritoneal dialysis patient: A case report and literature review.","journal":"Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis"},{"date":"2026 Feb","pmid":"41783235","title":"Effects of hydroxybisphosphonates-conjugated sitafloxacin on fracture healing and skeletal growth in mice.","journal":"JBMR plus"},{"date":"2026 Apr","pmid":"41770319","title":"[Superbugs Neisseria gonorrhoeae und Mycoplasma genitalium : Therapeutic challenges driven by antimicrobial resistance].","journal":"Dermatologie (Heidelberg, Germany)"},{"date":"2026","pmid":"41657899","title":"A single-center culture-based study of Helicobacter pylori in Kazakhstan with regional meta-analysis of prevalence and antibiotic resistance.","journal":"Frontiers in microbiology"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Daiichi Sankyo","companyId":"daiichi-sankyo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sitafloxacin is a small molecule bacterial DNA gyrase inhibitor, classified as an inhibitor. It is being studied in a clinical trial (NCT05400369) for the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD).","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2008-01-25T00:00:00.000Z","mah":"Daiichi Sankyo","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:54:41.362391+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}