{"id":"gemifloxacin","rwe":[{"pmid":"41599179","year":"2026","title":"Self-Stabilizing Covalent Ligand Targets Bacterial Phosphatidylethanolamine and Enhances Antibiotic Efficacy.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"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":"40996191","year":"2025","title":"In-vitro microbiological evaluation of gemifloxacin derivatives: Synthesis, vibrational spectroscopy, molecular docking and DFT studies.","finding":"","journal":"Pakistan journal of pharmaceutical sciences","studyType":"Clinical Study"},{"pmid":"40742477","year":"2025","title":"Gemifloxacin ameliorates acetic acid-induced ulcerative colitis via modulation of inflammatory, oxidative, and adhesive biomarkers and histopathological changes in rats.","finding":"","journal":"Journal of molecular histology","studyType":"Clinical Study"},{"pmid":"40578080","year":"2025","title":"High-efficiency photocatalytic degradation of multiple quinolone antibiotics using a hybrid heterojunction with synergistic doping of boron and bismuth.","finding":"","journal":"Journal of colloid and interface science","studyType":"Clinical Study"}],"tags":[{"label":"Quinolone Antimicrobial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01MA15","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute bacterial bronchitis","category":"indication"},{"label":"Acute exacerbation of chronic bronchitis","category":"indication"},{"label":"Bacterial pneumonia","category":"indication"},{"label":"Chlamydial pneumonia","category":"indication"},{"label":"Haemophilus influenzae pneumonia","category":"indication"},{"label":"Moraxella Catarrhalis Pneumonia","category":"indication"},{"label":"Lg Chem Ltd","category":"company"},{"label":"Approved 2000s","category":"decade"},{"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":{"drugInteractions":[{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"},{"url":"/drug/dronedarone","drug":"dronedarone","action":"Monitor closely","effect":"May interact with Dronedarone","source":"DrugCentral","drugSlug":"dronedarone"},{"url":"/drug/hydrocortisone","drug":"hydrocortisone","action":"Monitor closely","effect":"May interact with Hydrocortisone","source":"DrugCentral","drugSlug":"hydrocortisone"},{"url":"/drug/methylprednisolone","drug":"methylprednisolone","action":"Monitor closely","effect":"May interact with Methylprednisolone","source":"DrugCentral","drugSlug":"methylprednisolone"},{"url":"/drug/prednisolone","drug":"prednisolone","action":"Monitor closely","effect":"May interact with Prednisolone","source":"DrugCentral","drugSlug":"prednisolone"},{"url":"/drug/prednisone","drug":"prednisone","action":"Monitor closely","effect":"May interact with Prednisone","source":"DrugCentral","drugSlug":"prednisone"}],"commonSideEffects":[{"effect":"Headache","drugRate":"4.2%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"3.7%","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"3.5%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"2.2%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"1.6%","severity":"common","organSystem":""},{"effect":"Increased ALT","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Increased platelets","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Increased AST","drugRate":"1.3%","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"0.8%","severity":"common","organSystem":""},{"effect":"Increased creatine phosphokinase","drugRate":"0.7%","severity":"common","organSystem":""},{"effect":"Decreased neutrophils","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Increased neutrophils","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Increased alkaline phosphatase","drugRate":"0.4%","severity":"common","organSystem":""},{"effect":"Increased total bilirubin","drugRate":"0.4%","severity":"common","organSystem":""},{"effect":"Decreased hematocrit","drugRate":"0.3%","severity":"common","organSystem":""},{"effect":"Increased potassium","drugRate":"0.3%","severity":"common","organSystem":""},{"effect":"Increased blood urea nitrogen","drugRate":"0.3%","severity":"common","organSystem":""},{"effect":"Decreased albumin","drugRate":"0.3%","severity":"common","organSystem":""}],"contraindications":["Bradycardia","Congenital long QT syndrome","Depressive disorder","Epilepsy","Hypokalemia","Hypomagnesemia","Impaired renal function disorder","Myasthenia gravis","Peripheral nerve disease","Prolonged QT interval","Pseudomembranous enterocolitis","Tendinitis","Torsades de pointes","Transplant of kidney","Transplant of lung","Transplantation of heart"],"specialPopulations":{"Pregnancy":"...","Geriatric use":"In adult subjects, the pharmacokinetics of gemifloxacin are not affected by age.","Paediatric use":"The pharmacokinetics of gemifloxacin in pediatric subjects have not been studied.","Renal impairment":"...","Hepatic impairment":"The pharmacokinetics following single 320 mg dose of gemifloxacin were studied in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) liver disease. There was mean increase in AUC (0-inf) of 34% and mean increase in Cmax of 25% in these patients with hepatic impairment compared to healthy volunteers.The pharmacokinetics of single 320 mg dose of gemifloxacin were also studied in patients with severe hepatic impairment (Child-Pugh Class C). There was mean increase in AUC (0-inf) of 45% and mean increase in Cmax of 41% in these subjects with hepatic impairment compared to healthy volunteers.These average pharmacokinetic increases are not considered to be clinically significant. There was no"},"seriousAdverseEvents":[{"effect":"Rash","drugRate":"0.8%","severity":"serious"},{"effect":"Nausea","drugRate":"0.3%","severity":"serious"},{"effect":"Diarrhea","drugRate":"0.3%","severity":"serious"},{"effect":"Urticaria","drugRate":"0.2%","severity":"serious"},{"effect":"Vomiting","drugRate":"0.2%","severity":"serious"},{"effect":"Photosensitivity/phototoxicity reactions","drugRate":"0.1%","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"0.1%","severity":"serious"},{"effect":"Granulocytopenia","drugRate":"0.1%","severity":"serious"},{"effect":"Eosinophilia","drugRate":"0.1%","severity":"serious"},{"effect":"Anemia","drugRate":"0.1%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Lg Chem Ltd","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GEMIFLOXACIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:40:40.356733+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Gemifloxacin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:40:47.931670+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:40:46.454461+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GEMIFLOXACIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:40:46.881807+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Topoisomerase IV inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:40:47.931621+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200621/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:40:47.594699+00:00"}},"allNames":"factive","offLabel":[],"synonyms":["gemifloxacin mesilate","gemifloxacin","gemifloxacin mesylate"],"timeline":[{"date":"2002-12-27","type":"positive","source":"DrugCentral","milestone":"Korean Food and Drug Administration (KFDA) approval"},{"date":"2003-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from LG LIFE SCIENCES to Lg Chem Ltd"},{"date":"2003-04-04","type":"positive","source":"DrugCentral","milestone":"FDA approval (Lg Life Sciences)"},{"date":"2015-06-15","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Factive (Gemifloxacin) is a quinolone antimicrobial small molecule developed by LG Life Sciences and currently owned by LG Chem Ltd. It was FDA-approved in 2003 for various respiratory infections, including acute bacterial bronchitis, pneumonia, and exacerbation of chronic bronchitis. Factive is off-patent and has a generic manufacturer. Its half-life is approximately 8.3 hours. Key safety considerations include potential side effects such as nausea, diarrhea, and liver enzyme elevations.","approvals":[{"date":"2002-12-27","orphan":false,"company":"","regulator":"Korean Food and Drug Administration (KFDA)"},{"date":"2003-04-04","orphan":false,"company":"LG LIFE SCIENCES","regulator":"FDA"}],"brandName":"Factive","ecosystem":[{"indication":"Acute bacterial bronchitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefixime","slug":"cefixime","company":""}],"globalPrevalence":null},{"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":"Bacterial pneumonia","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Chlamydial pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"clarithromycin","slug":"clarithromycin","company":"Abbvie"},{"name":"erythromycin","slug":"erythromycin","company":"Arbor Pharms Llc"}],"globalPrevalence":null},{"indication":"Haemophilus influenzae pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Moraxella Catarrhalis Pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefdinir","slug":"cefdinir","company":""}],"globalPrevalence":null},{"indication":"Pneumococcal pneumonia","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"benzathine benzylpenicillin","slug":"benzathine-benzylpenicillin","company":"King Pharms"}],"globalPrevalence":null},{"indication":"Pneumonia due to Klebsiella pneumoniae","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"clavulanic acid","slug":"clavulanic-acid","company":"Dr Reddys Labs Inc"},{"name":"moxifloxacin","slug":"moxifloxacin","company":"Bayer Hlthcare"},{"name":"norfloxacin","slug":"norfloxacin","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Quinolone Antimicrobial","explanation":"","oneSentence":"","technicalDetail":"Gemifloxacin exerts its antibacterial effects by binding to the A subunit of DNA gyrase and the B subunit of topoisomerase IV, thereby inhibiting the enzymes' ability to relax supercoiled DNA and resolve topological stress, which is essential for bacterial DNA replication and transcription."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Gemifloxacin","title":"Gemifloxacin","extract":"Gemifloxacin mesylate, sold under the brand name Factive among others, is a broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. It is taken by mouth. Vansen Pharma Inc. licensed the active ingredient from LG Life Sciences of Korea."},"commercial":{"launchDate":"2003","_launchSource":"DrugCentral (FDA 2003-04-04, LG LIFE SCIENCES)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1286","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=GEMIFLOXACIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GEMIFLOXACIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Gemifloxacin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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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":"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":"gemifloxacin","indications":{"approved":[{"name":"Acute bacterial bronchitis","source":"DrugCentral","snomedId":233598009,"regulator":"FDA","eligibility":null},{"name":"Acute exacerbation of chronic 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Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-11-20","conditions":["Retinal Detachment","Achilles Tendon","Aneurysm, Dissecting"],"enrollment":117911,"completionDate":"2018-06-04"},{"nctId":"NCT04692623","phase":"PHASE1","title":"EFFECTS OF MOXIFLOXACIN AND GEMIFLOXACIN ON BLOOD GLUCOSE AND ECG MORPHOLOGY OF EUGLYCEMICS:A CLINICAL STUDY","status":"COMPLETED","sponsor":"Shaheed Benazir Bhutto University Sheringal Dir Upper","startDate":"2021-03-01","conditions":["Blood Glucose, Low","Hypoglycemia"],"enrollment":25,"completionDate":"2021-04-01"},{"nctId":"NCT04168099","phase":"PHASE3","title":"Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis","status":"RECRUITING","sponsor":"Tanta University","startDate":"2018-12-01","conditions":["Spontaneous Bacterial Peritonitis"],"enrollment":60,"completionDate":"2028-12-30"},{"nctId":"NCT03535558","phase":"","title":"Fluoroquinolone Associated Disability","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-05-17","conditions":["Bronchitis","Sinusitis","Urinary Tract Infections"],"enrollment":239306,"completionDate":"2018-12-31"},{"nctId":"NCT03326050","phase":"EARLY_PHASE1","title":"Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2018-02","conditions":["Rhinoscleroma"],"enrollment":60,"completionDate":"2018-10"},{"nctId":"NCT00926796","phase":"PHASE4","title":"Efficacy of Combination Therapies for Gonorrhea Treatment","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2010-06","conditions":["Gonorrhoea"],"enrollment":614,"completionDate":"2013-05"},{"nctId":"NCT02368470","phase":"PHASE3","title":"Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection","status":"UNKNOWN","sponsor":"Samsung Medical Center","startDate":"2015-02","conditions":["Helicobacter Pylori Infection"],"enrollment":252,"completionDate":"2015-10"},{"nctId":"NCT01881438","phase":"","title":"An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2000-01","conditions":["Retinal Detachment"],"enrollment":119924,"completionDate":"2013-05"},{"nctId":"NCT01879007","phase":"PHASE1","title":"Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)","status":"COMPLETED","sponsor":"LG Life 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B, Analytical technologies in the biomedical and life sciences"},{"date":"2025 Sep-Oct","pmid":"40996191","title":"In-vitro microbiological evaluation of gemifloxacin derivatives: Synthesis, vibrational spectroscopy, molecular docking and DFT studies.","journal":"Pakistan journal of pharmaceutical sciences"},{"date":"2025 Jul 31","pmid":"40742477","title":"Gemifloxacin ameliorates acetic acid-induced ulcerative colitis via modulation of inflammatory, oxidative, and adhesive biomarkers and histopathological changes in rats.","journal":"Journal of molecular histology"},{"date":"2025 Dec","pmid":"40578080","title":"High-efficiency photocatalytic degradation of multiple quinolone antibiotics using a hybrid heterojunction with synergistic doping of boron and bismuth.","journal":"Journal of colloid and interface science"}],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Orbion Pharms"],"status":"approved","companyName":"Lg Chem Ltd","companyId":"lg-chem-ltd","modality":"Small molecule","firstApprovalDate":"2003","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"OTHER","regulator":"Korean Food and Drug Administration (KFDA)","status":"approved","approval_date":"2002-12-27T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG LIFE SCIENCES","brand_name_local":null,"application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG LIFE SCIENCES","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG LIFE SCIENCES","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG LIFE SCIENCES","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG LIFE SCIENCES","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG LIFE SCIENCES","brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:40:49.499892+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}