{"id":"polymyxin-b","rwe":[{"pmid":"41894468","year":"2026","title":"Polymyxin heteroresistance in Klebsiella oxytoca.","finding":"","journal":"Journal of medical microbiology","studyType":"Clinical Study"},{"pmid":"41892426","year":"2026","title":"Impact of an Antimicrobial Stewardship Program on Antibiotic Consumption, Bacterial Susceptibility, and Costs in a High-Complexity Public Hospital.","finding":"","journal":"Antibiotics (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41887242","year":"2026","title":"Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial.","finding":"","journal":"The Lancet. Respiratory medicine","studyType":"Clinical Study"},{"pmid":"41884482","year":"2026","title":"A Multi-Center Study of Population Pharmacokinetics of Polymyxin B in Critically Ill Patients.","finding":"","journal":"Drug design, development and therapy","studyType":"Clinical Study"},{"pmid":"41880978","year":"2026","title":"First dose of cationic dendrimers determines the development of resistance or sensitivity to nanomaterials and antibiotics simultaneously in Pseudomonas aeruginosa.","finding":"","journal":"Colloids and surfaces. B, Biointerfaces","studyType":"Clinical Study"}],"_fda":{"id":"3aea3e3c-519b-7eb7-e063-6394a90a0c71","set_id":"0070ea5f-434d-53a7-e063-6294a90abf18","openfda":{"unii":["89Y4M234ES","057Y626693","19371312D4"],"route":["TOPICAL"],"rxcui":["204602"],"spl_id":["3aea3e3c-519b-7eb7-e063-6394a90a0c71"],"brand_name":["health and .beyond Triple Antibiotic"],"spl_set_id":["0070ea5f-434d-53a7-e063-6294a90abf18"],"package_ndc":["43473-050-01"],"product_ndc":["43473-050"],"generic_name":["BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BACITRACIN ZINC","NEOMYCIN SULFATE","POLYMYXIN B SULFATE"],"manufacturer_name":["Nantong Health & Beyond Hygienic Products Inc."],"application_number":["M004"],"is_original_packager":[true]},"purpose":["Purpose first aid antibiotic"],"version":"3","stop_use":["Stop use and ask a doctor if if the condition persists or gets worse a rash or other allergic reaction develops."],"warnings":["Warnings For external use only."],"ask_doctor":["Ask a doctor before use if you have deep or puncture wounds animal bites serious burns"],"do_not_use":["Do not use in eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor"],"effective_time":"20250727","active_ingredient":["Active Ingredients (in each gram) Bacitracin zinc (bacitracin 400 units) Neomycin sulfate（neomycin 3.5 mg） Polymyxin B sulfate (polymyxin B 5,000 units)"],"inactive_ingredient":["Inactive Ingredients White petrolatum"],"storage_and_handling":["Other Information Store at room temperature"],"indications_and_usage":["Uses First aid to help prevent infection in minor cuts, scrapes and burns"],"dosage_and_administration":["Directions Clean the affected area Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily May be covered with a sterile bandage."],"spl_product_data_elements":["health and .beyond Triple Antibiotic Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate PETROLATUM BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B"],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["image description"]},"tags":[{"label":"Polymyxin-class Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A07AA05","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Bacterial conjunctivitis","category":"indication"},{"label":"Bacterial keratitis","category":"indication"},{"label":"Bacterial septicemia","category":"indication"},{"label":"Blepharoconjunctivitis","category":"indication"},{"label":"Corneal abrasion","category":"indication"},{"label":"H. Influenzae Meningitis","category":"indication"},{"label":"Monarch Pharms","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"541 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"344 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"276 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"275 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"273 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"269 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"268 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"243 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"219 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"201 reports"}],"commonSideEffects":[{"effect":"Allergic contact dermatitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Itching","drugRate":"","severity":"common","organSystem":""},{"effect":"Burning","drugRate":"","severity":"common","organSystem":""},{"effect":"Irritation","drugRate":"","severity":"common","organSystem":""},{"effect":"Dryness","drugRate":"","severity":"common","organSystem":""},{"effect":"Folliculitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypertrichosis","drugRate":"","severity":"common","organSystem":""},{"effect":"Acneiform eruptions","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypopigmentation","drugRate":"","severity":"common","organSystem":""},{"effect":"Perioral dermatitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Maceration of the skin","drugRate":"","severity":"common","organSystem":""},{"effect":"Secondary infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Skin atrophy","drugRate":"","severity":"common","organSystem":""},{"effect":"Striae","drugRate":"","severity":"common","organSystem":""},{"effect":"Miliaria","drugRate":"","severity":"common","organSystem":""},{"effect":"Allergic sensitization","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Neomycin-induced allergic skin reactions","drugRate":"0.09%","severity":"common","organSystem":""},{"effect":"Skin sensitization","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Adrenal cortical hypofunction","Atrophoderma","Bacterial infection of eye","Bullous myringitis","Dehydration","Diabetes mellitus","Eye infection","Fungal ear infection","Fungal infection of eye","Hearing disorder","Herpes simplex","Herpes simplex dendritic keratitis","Herpes simplex keratitis","Herpes zoster auricularis","Injury of eye region","Kidney disease","Krukenberg spindle","Myasthenia gravis","Neuromuscular block, function","Ocular hypertension","Oliguria","Open wound","Open-angle glaucoma","Perforation of tympanic membrane","Peripheral vascular disease"],"specialPopulations":{"Pregnancy":"Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin sulfate, or bacitracin. It is also not known whether neomycin and polymyxin sulfates and bacitracin zinc ophthalmic ointment can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Neomycin and polymyxin sulfates and bacitracin zinc ophthalmic ointment should be given to pregnant woman only if clearly needed.","Geriatric use":"No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."},"seriousAdverseEvents":[{"effect":"Ototoxicity","drugRate":"","severity":"serious"},{"effect":"Nephrotoxicity","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=POLYMYXIN B","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:12:24.722385+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Polymyxin B","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:12:40.058768+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:12:37.719700+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:12:23.354257+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=POLYMYXIN B","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:12:38.696174+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:12:20.881991+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:12:20.882150+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:12:40.977146+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5314354/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:12:39.852898+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M004","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:12:20.882181+00:00"}},"allNames":"cortisporin","offLabel":[],"synonyms":["Polymyxin B sulfate","aerosporin","mastimyxin","Polymyxin B"],"timeline":[{"date":"1957-03-26","type":"positive","source":"DrugCentral","milestone":"FDA approval (Monarch Pharms)"}],"aiSummary":"Cortisporin (POLYMYXIN B) is a polymyxin-class antibacterial small molecule developed by Monarch Pharms in 1957. It is used to treat various bacterial infections, including conjunctivitis, keratitis, septicemia, and meningitis. Cortisporin is off-patent and has multiple generic manufacturers. As a polymyxin-class antibacterial, it works by disrupting bacterial cell membranes. Key safety considerations include potential nephrotoxicity and ototoxicity.","brandName":"Cortisporin","ecosystem":[{"indication":"Bacterial conjunctivitis","otherDrugs":[{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"besifloxacin","slug":"besifloxacin","company":"Bausch And Lomb"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"gatifloxacin","slug":"gatifloxacin","company":"Allergan"}],"globalPrevalence":null},{"indication":"Bacterial keratitis","otherDrugs":[{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"gentamicin","slug":"gentamicin","company":"Schering"}],"globalPrevalence":6000000},{"indication":"Bacterial septicemia","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azlocillin","slug":"azlocillin","company":"Bayer Pharmaceuticals Corp"},{"name":"cefalotin","slug":"cefalotin","company":"Lilly"}],"globalPrevalence":null},{"indication":"Blepharoconjunctivitis","otherDrugs":[{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"gentamicin","slug":"gentamicin","company":"Schering"}],"globalPrevalence":null},{"indication":"Corneal abrasion","otherDrugs":[{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"fluorometholone","slug":"fluorometholone","company":"Allergan"}],"globalPrevalence":null},{"indication":"H. Influenzae Meningitis","otherDrugs":[{"name":"cefotaxime","slug":"cefotaxime","company":"Sanofi Aventis Us"},{"name":"ceftazidime","slug":"ceftazidime","company":"Covis Injectables"},{"name":"ceftizoxime","slug":"ceftizoxime","company":""},{"name":"ceftriaxone","slug":"ceftriaxone","company":""}],"globalPrevalence":null},{"indication":"Infective blepharitis","otherDrugs":[{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"gentamicin","slug":"gentamicin","company":"Schering"}],"globalPrevalence":null},{"indication":"Keratitis","otherDrugs":[{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"}],"globalPrevalence":6000000}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Polymyxin-class Antibacterial","explanation":"","oneSentence":"","technicalDetail":"Cortisporin exerts its antibacterial effects by interacting with the bacterial cell membrane's lipid bilayer, specifically binding to the phosphate groups of the lipopolysaccharides, which disrupts the membrane's integrity and ultimately leads to bacterial cell lysis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Neomycin%2Fpolymyxin_B%2Fhydrocortisone","title":"Neomycin/polymyxin B/hydrocortisone","extract":"Neomycin/polymyxin B/hydrocortisone, sold under the brand Otosporin among others, is a medication used to treat otitis externa and certain eye disorders. It consists of the antibiotics neomycin and polymyxin B, and the steroid hydrocortisone. It is used as an ear drop or eye drop.","wiki_history":"==History==\nCortisporin was developed by Glaxo Wellcome and was approved by the US Food and Drug Administration in 1975.  In 1997, the rights were sold to Monarch Pharmaceuticals, a division of King Pharmaceuticals.  In 2007, King sold it to JHP Pharmaceuticals.  Par Pharmaceutical acquired JHP in 2014. In 2015, Endo International purchased Par.","wiki_society_and_culture":"== Society and culture ==\n=== Economics ===\nIn 2015, the price was $100, and in 2016, it reportedly was selling for $195. A generic version is priced at $144. The drug is owned by Dublin, Ireland-based Endo International.."},"commercial":{"launchDate":"1957","_launchSource":"DrugCentral (FDA 1957-03-26, MONARCH PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4246","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=POLYMYXIN%20B","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=POLYMYXIN B","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Neomycin%2Fpolymyxin_B%2Fhydrocortisone","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 Book"}],"_enrichedAt":"2026-03-30T07:25:56.638144","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:12:42.702330+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"neomycin","drugSlug":"neomycin","fdaApproval":"1957-03-26","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"nystatin","drugSlug":"nystatin","fdaApproval":"1964-07-08","genericCount":48,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"natamycin","drugSlug":"natamycin","fdaApproval":"1978-10-30","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"streptomycin","drugSlug":"streptomycin","fdaApproval":"1946-02-18","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"paromomycin","drugSlug":"paromomycin","fdaApproval":"1969-03-24","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amphotericin B","drugSlug":"amphotericin-b","fdaApproval":"1964-11-12","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"kanamycin","drugSlug":"kanamycin","fdaApproval":"1973-02-13","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"vancomycin","drugSlug":"vancomycin","fdaApproval":"1964-11-06","patentExpiry":"Nov 6, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"colistin","drugSlug":"colistin","fdaApproval":"1962-05-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"rifaximin","drugSlug":"rifaximin","fdaApproval":"2004-05-25","patentExpiry":"Sep 2, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fidaxomicin","drugSlug":"fidaxomicin","fdaApproval":"2011-05-27","patentExpiry":"Sep 4, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"rifamycin","drugSlug":"rifamycin","fdaApproval":"2018-11-16","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"polymyxin b","indications":{"approved":[{"name":"Bacterial conjunctivitis","source":"DrugCentral","snomedId":128350005,"regulator":"FDA","eligibility":"Adults and children 1 year of age and older"},{"name":"Bacterial keratitis","source":"DrugCentral","snomedId":314557000,"regulator":"FDA","eligibility":"Adults and children 1 year of age and older","usPrevalence":null,"globalPrevalence":6000000,"prevalenceMethod":"curated","prevalenceSource":"Cochrane Database Syst Rev, 2025 (PMID:40728038)"},{"name":"Bacterial septicemia","source":"DrugCentral","snomedId":10001005,"regulator":"FDA","eligibility":"Not specified"},{"name":"Blepharoconjunctivitis","source":"DrugCentral","snomedId":68659002,"regulator":"FDA","eligibility":"Not specified"},{"name":"Corneal abrasion","source":"DrugCentral","snomedId":85848002,"regulator":"FDA","eligibility":"Not specified"},{"name":"H. Influenzae Meningitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Children 3 months to 5 years of age"},{"name":"Infective blepharitis","source":"DrugCentral","snomedId":312219000,"regulator":"FDA","eligibility":"Not specified"},{"name":"Keratitis","source":"DrugCentral","snomedId":5888003,"regulator":"FDA","eligibility":"Not specified","usPrevalence":null,"globalPrevalence":6000000,"prevalenceMethod":"curated","prevalenceSource":"Cochrane Database Syst Rev, 2025 (PMID:40728038)"},{"name":"Mastoidectomy Cavity Infections","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Not specified"},{"name":"Minor Bacterial Skin Infections","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children 2 months of age and older"},{"name":"Minor Skin Wound Pain","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Otitis externa","source":"DrugCentral","snomedId":3135009,"regulator":"FDA"},{"name":"Superficial Ocular Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","usPrevalence":null,"globalPrevalence":6000000,"prevalenceMethod":"curated","prevalenceSource":"Cochrane Database Syst Rev, 2025 (PMID:40728038)"},{"name":"Urinary tract infectious disease","source":"DrugCentral","snomedId":68566005,"regulator":"FDA"},{"name":"Uveitis","source":"DrugCentral","snomedId":128473001,"regulator":"FDA","usPrevalence":null,"globalPrevalence":3040000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (8407119[PMID])"}],"offLabel":[{"name":"Chronic purulent otitis media","source":"DrugCentral","drugName":"POLYMYXIN B","evidenceCount":19,"evidenceLevel":"moderate"},{"name":"Corneal ulcer","source":"DrugCentral","drugName":"POLYMYXIN B","evidenceCount":38,"evidenceLevel":"moderate"},{"name":"Dacryocystitis","source":"DrugCentral","drugName":"POLYMYXIN B","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Meibomianitis","source":"DrugCentral","drugName":"POLYMYXIN B","evidenceCount":1,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"neomycin","brandName":"neomycin","genericName":"neomycin","approvalYear":"1957","relationship":"same-class"},{"drugId":"nystatin","brandName":"nystatin","genericName":"nystatin","approvalYear":"1964","relationship":"same-class"},{"drugId":"natamycin","brandName":"natamycin","genericName":"natamycin","approvalYear":"1978","relationship":"same-class"},{"drugId":"streptomycin","brandName":"streptomycin","genericName":"streptomycin","approvalYear":"1946","relationship":"same-class"},{"drugId":"paromomycin","brandName":"paromomycin","genericName":"paromomycin","approvalYear":"1969","relationship":"same-class"},{"drugId":"amphotericin-b","brandName":"amphotericin B","genericName":"amphotericin B","approvalYear":"1964","relationship":"same-class"},{"drugId":"kanamycin","brandName":"kanamycin","genericName":"kanamycin","approvalYear":"1973","relationship":"same-class"},{"drugId":"vancomycin","brandName":"vancomycin","genericName":"vancomycin","approvalYear":"1964","relationship":"same-class"},{"drugId":"colistin","brandName":"colistin","genericName":"colistin","approvalYear":"1962","relationship":"same-class"},{"drugId":"rifaximin","brandName":"rifaximin","genericName":"rifaximin","approvalYear":"2004","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07495150","phase":"NA","title":"Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis","status":"NOT_YET_RECRUITING","sponsor":"yilong Wang","startDate":"2026-04-01","conditions":["Blood-Brain Barrier","Bacterial Meningitis"],"enrollment":86,"completionDate":"2027-07-01"},{"nctId":"NCT06966284","phase":"","title":"A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection","status":"RECRUITING","sponsor":"TTY Biopharm","startDate":"2025-11-26","conditions":["Bacteremia Caused by Gram-Negative Bacteria","Bacterial Pneumonia"],"enrollment":480,"completionDate":"2028-11-30"},{"nctId":"NCT07431307","phase":"PHASE2","title":"Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","status":"NOT_YET_RECRUITING","sponsor":"BioVersys AG","startDate":"2026-07","conditions":["Ventilator Associated Bacterial Pneumonia (VABP)","Hospital Acquired Bacterial Pneumonia (HABP)","Blood Stream Infection","Meningitis, Bacterial","Ventriculitis, Infectious"],"enrollment":120,"completionDate":"2028-07"},{"nctId":"NCT03901807","phase":"NA","title":"Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Spectral Diagnostics (US) Inc.","startDate":"2020-01-09","conditions":["Septic Shock","Endotoxemia"],"enrollment":150,"completionDate":"2026-04-30"},{"nctId":"NCT06522945","phase":"PHASE1","title":"To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects","status":"COMPLETED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2024-07-24","conditions":["Multi-resistant Gram-negative Bacteria Cause Infection"],"enrollment":48,"completionDate":"2025-12-18"},{"nctId":"NCT07326540","phase":"PHASE3","title":"Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","status":"NOT_YET_RECRUITING","sponsor":"BioVersys SAS","startDate":"2026-03-20","conditions":["Hospital Acquired Bacterial Pneumonia (HABP)","Ventilator Associated Bacterial Pneumonia (VABP)","Colistin Resistanrt ABC","Acinetobacter Baumannii-calcoaceticus Complex"],"enrollment":248,"completionDate":"2028-03-30"},{"nctId":"NCT07086391","phase":"","title":"Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.","status":"RECRUITING","sponsor":"Fujian Medical University Union Hospital","startDate":"2023-02-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection","Pneumonia - Bacterial"],"enrollment":144,"completionDate":"2026-02-01"},{"nctId":"NCT05157113","phase":"PHASE4","title":"Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2022-05-31","conditions":["Cataract","Surgery","Compliance, Patient","Compliance, Medication","Satisfaction, Patient"],"enrollment":70,"completionDate":"2026-06-01"},{"nctId":"NCT05331664","phase":"PHASE4","title":"Dropless Pars Plana Vitrectomy Study","status":"RECRUITING","sponsor":"Massachusetts Eye and Ear Infirmary","startDate":"2022-07-25","conditions":["Rhegmatogenous Retinal Detachment"],"enrollment":168,"completionDate":"2027-01-30"},{"nctId":"NCT07004049","phase":"PHASE4","title":"Optimising TREATment for Severe Gram-Negative Bacterial Infections","status":"RECRUITING","sponsor":"National University of Singapore","startDate":"2025-04-21","conditions":["Bloodstream Infection","Ventilator Associated Bacterial Pneumonia","Hospital Acquired Bacterial Pneumonia","Carbapenem Resistant Bacterial Infection","Multidrug Resistance"],"enrollment":600,"completionDate":"2028-12-31"},{"nctId":"NCT05685615","phase":"PHASE2","title":"PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB","status":"COMPLETED","sponsor":"BioVersys AG","startDate":"2023-04-20","conditions":["Ventilator Associated Pneumonia"],"enrollment":39,"completionDate":"2024-12-11"},{"nctId":"NCT06739382","phase":"PHASE3","title":"Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center","status":"COMPLETED","sponsor":"Beni-Suef University","startDate":"2021-01-01","conditions":["Ventilation Acquired Pneumonia"],"enrollment":64,"completionDate":"2022-01-01"},{"nctId":"NCT02682355","phase":"","title":"Optimizing Clinical Use of Polymyxin B","status":"COMPLETED","sponsor":"Rutgers, The State University of New Jersey","startDate":"2016-02","conditions":["Pneumonia","Blood Stream Infection","Urinary Tract Infections","Respiratory Tract Infection (Including Tracheobronchitis)","Sepsis"],"enrollment":155,"completionDate":"2022-08-03"},{"nctId":"NCT04920565","phase":"NA","title":"Efficacy and Safety of Hemoperfusion With Polymyxin B in Septic Shock Associated With Severe Endotoxemia in Cardiac Surgery Patients (РМХ vs SS)","status":"RECRUITING","sponsor":"Petrovsky National Research Centre of Surgery","startDate":"2021-11-01","conditions":["Multiple Organ Dysfunction With Severe Endotoxemia"],"enrollment":20,"completionDate":"2025-12"},{"nctId":"NCT06670872","phase":"","title":"A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia","status":"NOT_YET_RECRUITING","sponsor":"Peking University Third Hospital","startDate":"2024-10","conditions":["Pneumonitis","Acinetobacter Baumannii"],"enrollment":50,"completionDate":"2026-10"},{"nctId":"NCT06595979","phase":"","title":"Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2024-06-25","conditions":["Intracranial Infections"],"enrollment":222,"completionDate":"2026-12"},{"nctId":"NCT05386810","phase":"PHASE3","title":"Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2020-11-05","conditions":["Poliomyelitis"],"enrollment":1572,"completionDate":"2023-07-20"},{"nctId":"NCT05063422","phase":"PHASE1","title":"Retentive Strength of Denture Adhesives on Various RR Ridges","status":"COMPLETED","sponsor":"Altamash Institute of Dental Medicine","startDate":"2022-08-18","conditions":["Retentive Strength of Denture Adhesives"],"enrollment":24,"completionDate":"2023-08-17"},{"nctId":"NCT03920007","phase":"PHASE1,PHASE2","title":"Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D","status":"ACTIVE_NOT_RECRUITING","sponsor":"Atsena Therapeutics Inc.","startDate":"2019-09-12","conditions":["Leber Congenital Amaurosis","LCA","LCA1"],"enrollment":15,"completionDate":"2027-05-19"},{"nctId":"NCT06180265","phase":"NA","title":"The Diagnostic and Prognostic Value of Presepsin in Sepsis","status":"COMPLETED","sponsor":"University of Foggia","startDate":"2020-02-01","conditions":["Septic Shock"],"enrollment":90,"completionDate":"2023-07-19"},{"nctId":"NCT06076603","phase":"","title":"Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients","status":"UNKNOWN","sponsor":"Southeast University, China","startDate":"2023-07-01","conditions":["Polymyxin B","Ventilator-associated Pneumonia","Multidrug Resistant Bacterial Infection","Pharmacogenomic Drug Interaction"],"enrollment":30,"completionDate":"2024-08-01"},{"nctId":"NCT05449392","phase":"PHASE1","title":"Topical Antibacterial Agents for Prevention of COVID-19","status":"COMPLETED","sponsor":"Yale University","startDate":"2022-09-01","conditions":["COVID-19","SARS-CoV2 Infection"],"enrollment":67,"completionDate":"2023-09-22"},{"nctId":"NCT02641236","phase":"PHASE2","title":"Gut Decontamination In Pediatric Allogeneic Hematopoietic","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2016-03","conditions":["Hematopoietic Stem Cell Transplantation (HSCT)","Acute GVH Disease"],"enrollment":24,"completionDate":"2021-10-28"},{"nctId":"NCT04649541","phase":"PHASE1","title":"Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts","status":"COMPLETED","sponsor":"MicuRx","startDate":"2020-11-29","conditions":["Safety"],"enrollment":69,"completionDate":"2021-12-01"},{"nctId":"NCT04335370","phase":"","title":"Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2019-01-09","conditions":["Cystic Fibrosis","Polymyxin B"],"enrollment":9,"completionDate":"2021-07-01"},{"nctId":"NCT05359627","phase":"PHASE1","title":"A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency","status":"COMPLETED","sponsor":"TTY Biopharm","startDate":"2022-07-26","conditions":["Antibiotic Toxicity"],"enrollment":22,"completionDate":"2023-03-03"},{"nctId":"NCT03894046","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex","status":"COMPLETED","sponsor":"Entasis Therapeutics","startDate":"2019-09-05","conditions":["Acinetobacter Baumannii-calcoaceticus Complex","Hospital-acquired Bacterial Pneumonia","Ventilator-associated Bacterial Pneumonia","Bacteremia","Colistin Resistant ABC"],"enrollment":207,"completionDate":"2021-07-26"},{"nctId":"NCT02873806","phase":"PHASE4","title":"Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents","status":"COMPLETED","sponsor":"Glaukos Corporation","startDate":"2013-03","conditions":["Open-angle Glaucoma"],"enrollment":53,"completionDate":"2019-11-08"},{"nctId":"NCT04876430","phase":"PHASE2,PHASE3","title":"Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems","status":"TERMINATED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2021-05-04","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection","Bloodstream Infection"],"enrollment":13,"completionDate":"2022-03-07"},{"nctId":"NCT02186457","phase":"NA","title":"Antibiotic Irrigation for Pancreatoduodenectomy","status":"COMPLETED","sponsor":"Indiana University","startDate":"2014-11","conditions":["Surgery","Infection"],"enrollment":190,"completionDate":"2019-08"},{"nctId":"NCT00000635","phase":"NA","title":"Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":["Herpes Simplex","HIV Infections"],"enrollment":25,"completionDate":"1992-04"},{"nctId":"NCT04352985","phase":"","title":"Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19","status":"NO_LONGER_AVAILABLE","sponsor":"Spectral Diagnostics (US) Inc.","startDate":"","conditions":["Septic Shock","Endotoxemia","COVID","Corona Virus Infection","Sepsis, Severe"],"enrollment":0,"completionDate":""},{"nctId":"NCT02825329","phase":"","title":"Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock","status":"TEMPORARILY_NOT_AVAILABLE","sponsor":"Spectral Diagnostics (US) Inc.","startDate":"","conditions":["Septic Shock","Endotoxemia"],"enrollment":0,"completionDate":""},{"nctId":"NCT03725267","phase":"PHASE2","title":"Melatonin for Renal Protection in Patients Receiving Polymyxin B","status":"TERMINATED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2018-10-01","conditions":["Acute Kidney Injury","Melatonin","Polymyxin B Adverse Reaction"],"enrollment":88,"completionDate":"2021-07-01"},{"nctId":"NCT04970537","phase":"","title":"Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection","status":"UNKNOWN","sponsor":"Xiangya Hospital of Central South University","startDate":"2017-07-23","conditions":["Tigecycline","Polymyxin B","Intensive Care Unit"],"enrollment":800,"completionDate":"2021-07-31"},{"nctId":"NCT04839653","phase":"NA","title":"Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria","status":"UNKNOWN","sponsor":"MEDSI Clinical Hospital 1, ICU","startDate":"2021-05-01","conditions":["Pneumonia, Ventilator-Associated","Pneumonia","Bloodstream Infection","Sepsis","Respiratory Distress Syndrome","Respiratory Tract Infections","Critical Illness"],"enrollment":60,"completionDate":"2023-04"},{"nctId":"NCT02099240","phase":"EARLY_PHASE1","title":"Patients Response to Early Switch To Oral:Osteomyelitis Study","status":"TERMINATED","sponsor":"Julio Ramirez","startDate":"2014-03-06","conditions":["Osteomyelitis"],"enrollment":11,"completionDate":"2018-11-07"},{"nctId":"NCT02413541","phase":"NA","title":"The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis","status":"COMPLETED","sponsor":"Chulalongkorn University","startDate":"2015-01","conditions":["Severe Sepsis"],"enrollment":90,"completionDate":"2017-08-30"},{"nctId":"NCT01429701","phase":"PHASE3","title":"Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous","status":"COMPLETED","sponsor":"EMS","startDate":"2012-05","conditions":["Eczema"],"enrollment":76,"completionDate":"2012-08"},{"nctId":"NCT04208763","phase":"NA","title":"A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.","status":"UNKNOWN","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2019-12-20","conditions":["Spontaneous Bacterial Peritonitis"],"enrollment":90,"completionDate":"2021-12-31"},{"nctId":"NCT01950598","phase":"NA","title":"Frozen Versus Fresh Corneal Carriers for the Boston KPro Type I Donor Carriers","status":"COMPLETED","sponsor":"Marie-Claude Robert","startDate":"2013-09","conditions":["Corneal Blindness","Boston Keratoprosthesis Type I Candidate"],"enrollment":37,"completionDate":"2020-11"},{"nctId":"NCT03397914","phase":"PHASE4","title":"Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections","status":"COMPLETED","sponsor":"National Cancer Institute, Egypt","startDate":"2017-01","conditions":["Gram-Negative Bacterial Infections","Pediatric Cancer","Colistin","Colistin Adverse Reaction","MIC"],"enrollment":70,"completionDate":"2019-03"},{"nctId":"NCT04489459","phase":"PHASE4","title":"Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae","status":"UNKNOWN","sponsor":"Al-Azhar University","startDate":"2019-09-21","conditions":["Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae"],"enrollment":60,"completionDate":"2020-07"},{"nctId":"NCT02792036","phase":"PHASE1","title":"Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma","status":"COMPLETED","sponsor":"St. Jude Children's Research Hospital","startDate":"2016-11-01","conditions":["Retinoblastoma"],"enrollment":8,"completionDate":"2019-10-04"},{"nctId":"NCT02582255","phase":"PHASE4","title":"A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania","status":"COMPLETED","sponsor":"Fidec Corporation","startDate":"2015-11","conditions":["Poliomyelitis"],"enrollment":100,"completionDate":"2016-12-22"},{"nctId":"NCT02134106","phase":"PHASE2,PHASE3","title":"Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria","status":"WITHDRAWN","sponsor":"Tan Tock Seng Hospital","startDate":"2015-01","conditions":["Bacteremia","Healthcare-associated Pneumonia","Ventilator-associated Pneumonia"],"enrollment":0,"completionDate":"2015-12"},{"nctId":"NCT01948778","phase":"NA","title":"The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study (ENDoX-study)","status":"COMPLETED","sponsor":"University of Zurich","startDate":"2013-08","conditions":["Patients in Septic Shock"],"enrollment":38,"completionDate":"2019-07"},{"nctId":"NCT01756755","phase":"NA","title":"Endotoxin Adsorber Hemoperfusion and Microcirculation","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2012-12","conditions":["Sepsis"],"enrollment":29,"completionDate":"2019-06"},{"nctId":"NCT03950544","phase":"EARLY_PHASE1","title":"The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae","status":"UNKNOWN","sponsor":"Shanghai 10th People's Hospital","startDate":"2019-01-01","conditions":["Antibiotic Resistant Infection"],"enrollment":80,"completionDate":"2020-12-31"},{"nctId":"NCT01646229","phase":"NA","title":"Impact of Early Peri-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery","status":"COMPLETED","sponsor":"University Hospital, Geneva","startDate":"2012-01","conditions":["Abdominal Sepsis","Peritonitis","Colon Perforation"],"enrollment":28,"completionDate":"2015-02"},{"nctId":"NCT02871024","phase":"NA","title":"Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection","status":"TERMINATED","sponsor":"National Taiwan University Hospital","startDate":"2016-08","conditions":["Sepsis"],"enrollment":1,"completionDate":"2019-03-26"},{"nctId":"NCT01046669","phase":"NA","title":"Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock","status":"COMPLETED","sponsor":"Spectral Diagnostics (US) Inc.","startDate":"2010-06","conditions":["Septic Shock","Endotoxemia"],"enrollment":450,"completionDate":"2017-06"},{"nctId":"NCT03159078","phase":"PHASE3","title":"Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens","status":"UNKNOWN","sponsor":"University of Puerto Rico","startDate":"2017-05-25","conditions":["Trauma","Resistant Infection","Critical Illness"],"enrollment":40,"completionDate":"2019-12-01"},{"nctId":"NCT02515656","phase":"PHASE3","title":"Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis","status":"COMPLETED","sponsor":"Laboratoire Innotech International","startDate":"2015-09","conditions":["Vaginitis"],"enrollment":661,"completionDate":"2016-08"},{"nctId":"NCT00695578","phase":"PHASE4","title":"Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy","status":"COMPLETED","sponsor":"Wake Forest University","startDate":"2006-10","conditions":["Actinic Keratosis"],"enrollment":20,"completionDate":"2008-02"},{"nctId":"NCT01740947","phase":"PHASE4","title":"Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?","status":"TERMINATED","sponsor":"H. Jaap Bonjer, PhD","startDate":"2013-01","conditions":["Colorectal Cancer"],"enrollment":485,"completionDate":"2017-03"},{"nctId":"NCT03715387","phase":"PHASE2,PHASE3","title":"Tacrolimus for Malar Edema","status":"UNKNOWN","sponsor":"University of British Columbia","startDate":"2018-10-10","conditions":["Edema Face"],"enrollment":100,"completionDate":"2019-07-01"},{"nctId":"NCT01843920","phase":"NA","title":"The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble","status":"COMPLETED","sponsor":"Jason Hsu, MD","startDate":"2011-06","conditions":["Scleral Buckling"],"enrollment":21,"completionDate":"2013-04"},{"nctId":"NCT03177330","phase":"","title":"Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2017-05-15","conditions":["Septic Shock","Polymyxin B Hemoperfusion"],"enrollment":30,"completionDate":"2017-07"},{"nctId":"NCT01431170","phase":"PHASE1","title":"Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children","status":"COMPLETED","sponsor":"Rutgers, The State University of New Jersey","startDate":"2011-09","conditions":["Congenital Nasolacrimal Duct Obstruction"],"enrollment":24,"completionDate":"2014-06"},{"nctId":"NCT00581542","phase":"PHASE4","title":"Moxifloxacin vs. Polytrim for Conjunctivitis","status":"COMPLETED","sponsor":"University of Rochester","startDate":"2007-03","conditions":["Conjunctivitis"],"enrollment":124,"completionDate":"2012-03"},{"nctId":"NCT02320695","phase":"NA","title":"Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer and Personal Products Worldwide","startDate":"2015-03","conditions":["Sting"],"enrollment":60,"completionDate":"2015-03"},{"nctId":"NCT02328183","phase":"PHASE4","title":"Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria","status":"UNKNOWN","sponsor":"Mahidol University","startDate":"2014-12","conditions":["Hospital Infection"],"enrollment":100,"completionDate":"2015-11"},{"nctId":"NCT02497326","phase":"NA","title":"Heparin for the Treatment of Burn Wound Pain","status":"UNKNOWN","sponsor":"King Edward Medical University","startDate":"2015-04","conditions":["Second Degree Burns"],"enrollment":36,"completionDate":"2015-12"},{"nctId":"NCT02344732","phase":"NA","title":"Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy","status":"COMPLETED","sponsor":"Universiti Sains Malaysia","startDate":"2013-10","conditions":["Corneal Diseases"],"enrollment":32,"completionDate":"2014-10"},{"nctId":"NCT00752375","phase":"PHASE3","title":"Antibiotic Prophylaxis in Children With Pyelonephritis","status":"WITHDRAWN","sponsor":"University of Alberta","startDate":"2009-02","conditions":["Pyelonephritis"],"enrollment":0,"completionDate":"2014-12"},{"nctId":"NCT00997139","phase":"NA","title":"Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2009-09","conditions":["Nasal Carriers of Staphylococcus Aureus"],"enrollment":216,"completionDate":"2010-11"},{"nctId":"NCT01222663","phase":"PHASE3","title":"Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock","status":"COMPLETED","sponsor":"Meditor SAS","startDate":"2010-10","conditions":["Peritonitis","Septic Shock"],"enrollment":243,"completionDate":"2013-12"},{"nctId":"NCT01584271","phase":"PHASE2","title":"Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)","status":"UNKNOWN","sponsor":"Assuta Hospital Systems","startDate":"2011-07","conditions":["Acute Otitis Externa"],"enrollment":75,"completionDate":"2013-12"},{"nctId":"NCT01809483","phase":"PHASE3","title":"Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients","status":"COMPLETED","sponsor":"Udayana University","startDate":"2012-09","conditions":["Erosion; Cornea, Traumatic"],"enrollment":32,"completionDate":"2013-02"},{"nctId":"NCT00674999","phase":"PHASE2,PHASE3","title":"Use of Amnion on Partial Thickness Burns","status":"WITHDRAWN","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2005-06","conditions":["Burn"],"enrollment":0,"completionDate":"2008-09"},{"nctId":"NCT00534391","phase":"PHASE3","title":"Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage","status":"UNKNOWN","sponsor":"Chulalongkorn University","startDate":"2007-09","conditions":["Hordeolum"],"enrollment":120,"completionDate":"2008-12"},{"nctId":"NCT01227863","phase":"PHASE3","title":"Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis","status":"UNKNOWN","sponsor":"Azidus Brasil","startDate":"2011-02","conditions":["Bacterial Conjunctivitis","Acute"],"enrollment":70,"completionDate":""},{"nctId":"NCT00490477","phase":"PHASE3","title":"The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial","status":"COMPLETED","sponsor":"University of Turin, Italy","startDate":"2006-05","conditions":["Gram-Negative Bacterial Infections","Sepsis"],"enrollment":16,"completionDate":"2007-12"},{"nctId":"NCT00645723","phase":"PHASE3","title":"Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii","status":"UNKNOWN","sponsor":"Hospitales Universitarios Virgen del Rocío","startDate":"2008-04","conditions":["Cross Infection","Pneumonia, Bacterial"],"enrollment":67,"completionDate":"2011-04"},{"nctId":"NCT00629382","phase":"PHASE4","title":"Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis","status":"COMPLETED","sponsor":"St. Bortolo Hospital","startDate":"2004-12","conditions":["Gram-Negative Bacterial Infections","Sepsis","Septic Shock"],"enrollment":70,"completionDate":"2008-04"},{"nctId":"NCT00704977","phase":"NA","title":"Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods","status":"UNKNOWN","sponsor":"Soroka University Medical Center","startDate":"2008-06","conditions":["Pterygium"],"enrollment":150,"completionDate":"2010-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Cream","formulations":[{"form":"CREAM","route":"TOPICAL","productName":"Cortisporin"},{"form":"CREAM","route":"TOPICAL","productName":"Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"CAREONE Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"Equate Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"Equate Antibiotic Plus Pain, Itch, Scar Relief"},{"form":"CREAM","route":"TOPICAL","productName":"Equate First Aid Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"GoodSense Antibiotic plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"LiveBetter Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"Publix antibiotic plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"Shopko Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"TopCare Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"equaline antibiotic plus pain relief for kids"},{"form":"CREAM","route":"TOPICAL","productName":"meijer Antibiotic Plus Pain Relief"},{"form":"CREAM","route":"TOPICAL","productName":"sunmark antibiotic plus pain relief"},{"form":"CREAM","route":"TOPICAL","productName":"Antibiotic and Pain ReliefMaximum Strength"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146438","MMSL":"1703","NDDF":"002803","UNII":"J2VZ07J96K","VUID":"4018100","CHEBI":"CHEBI:8310","VANDF":"4018100","INN_ID":"490","RXNORM":"202404","UMLSCUI":"C0032535","chemblId":"CHEMBL5314354","ChEMBL_ID":"CHEMBL3989738","KEGG_DRUG":"D08401","DRUGBANK_ID":"DB00781","PUBCHEM_CID":"4868","SNOMEDCT_US":"372824005","IUPHAR_LIGAND_ID":"10338","SECONDARY_CAS_RN":"1404-26-8","MESH_DESCRIPTOR_UI":"D011112"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1957-","companyName":"Monarch Pharms","relationship":"Original Developer"}],"publicationCount":7073,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"A07AA05","allCodes":["A07AA05","J01XB02","S01AA18","S02AA11","S03AA03"]},"biosimilarFilings":[],"originalDeveloper":"Monarch Pharms","recentPublications":[{"date":"2026 Mar","pmid":"41894468","title":"Polymyxin heteroresistance in Klebsiella oxytoca.","journal":"Journal of medical microbiology"},{"date":"2026 Mar 3","pmid":"41892426","title":"Impact of an Antimicrobial Stewardship Program on Antibiotic Consumption, Bacterial Susceptibility, and Costs in a High-Complexity Public Hospital.","journal":"Antibiotics (Basel, Switzerland)"},{"date":"2026 Mar 23","pmid":"41887242","title":"Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial.","journal":"The Lancet. Respiratory medicine"},{"date":"2026","pmid":"41884482","title":"A Multi-Center Study of Population Pharmacokinetics of Polymyxin B in Critically Ill Patients.","journal":"Drug design, development and therapy"},{"date":"2026 Mar 18","pmid":"41880978","title":"First dose of cationic dendrimers determines the development of resistance or sensitivity to nanomaterials and antibiotics simultaneously in Pseudomonas aeruginosa.","journal":"Colloids and surfaces. B, Biointerfaces"}],"companionDiagnostics":[],"genericManufacturers":10,"_genericFilersChecked":true,"genericManufacturerList":["Eugia Pharma","Fresenius Kabi Usa","Gland","Glaxosmithkline","Hikma","Paddock Llc","Pharmobedient","Rising","X Gen Pharms","Xellia Pharms Aps"],"status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Recombinant protein","firstApprovalDate":"1957","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1993-12-03T00:00:00.000Z","mah":"SANDOZ","brand_name_local":null,"application_number":"ANDA062423"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1997-07-23T00:00:00.000Z","mah":"BAUSCH AND LOMB","brand_name_local":null,"application_number":"ANDA064063"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1999-06-07T00:00:00.000Z","mah":"BAUSCH AND LOMB","brand_name_local":null,"application_number":"ANDA064053"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2000-06-27T00:00:00.000Z","mah":"BAUSCH AND LOMB","brand_name_local":null,"application_number":"ANDA064046"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2001-03-07T00:00:00.000Z","mah":"BAUSCH AND LOMB","brand_name_local":null,"application_number":"ANDA064047"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"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":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"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":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"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":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:12:42.702330+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}