{"id":"lefamulin","rwe":[{"pmid":"41823576","year":"2026","title":"Lefamulin versus omadacycline for community acquired bacterial pneumonia: a systematic review and anchored indirect treatment comparison using moxifloxacin as the common comparator.","finding":"","journal":"Journal of comparative effectiveness research","studyType":"Clinical Study"},{"pmid":"41820042","year":"2026","title":"[Annual review of community-acquired pneumonia (CAP) 2025].","finding":"","journal":"Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases","studyType":"Clinical Study"},{"pmid":"41760492","year":"2026","title":"In vitro activity of recently introduced Gram-positive-specific antimicrobial agents against Australian methicillin-resistant Staphylococcus aureus isolates.","finding":"","journal":"Pathology","studyType":"Clinical Study"},{"pmid":"41653190","year":"2026","title":"Electrostatic Trojan Horse: Charge-Anchored Pleuromutilin Breaches Anionic Barriers to Hijack Ribosomes in Antibiotic-Resistant Bacteria.","finding":"","journal":"ACS infectious diseases","studyType":"Clinical Study"},{"pmid":"41608681","year":"2025","title":"Molecular resistance mechanisms to newly approved antibiotics (2017-2025) in WHO priority pathogens.","finding":"","journal":"Frontiers in microbiology","studyType":"Clinical Study"}],"tags":[{"label":"Pleuromutilin Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01XX12","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Injection","category":"form"},{"label":"Tablet","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Bacterial pneumonia","category":"indication"},{"label":"Bronchopneumonia due to Haemophilus influenzae","category":"indication"},{"label":"Haemophilus influenzae pneumonia","category":"indication"},{"label":"Legionella pneumonia","category":"indication"},{"label":"Pneumonia caused by Chlamydia pneumoniae","category":"indication"},{"label":"Pneumonia due to Mycoplasma pneumoniae","category":"indication"},{"label":"Hong Kong","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Hepatic enzyme elevation","drugRate":"","severity":"common","organSystem":""},{"effect":"Administration site reactions","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypokalemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""}],"specialPopulations":{"Lactation":"Because of the potential for serious adverse reactions, including QT prolongation, woman should pump and discard human milk for the duration of treatment with XENLETA and for days after the final dose.","Pregnancy":"Based on findings from animal studies, lefamulin may cause fetal harm when administered to pregnant women. There are no available data on the use of XENLETA in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.","Geriatric use":"Of the 646 patients randomized to XENLETA in Trials and 2, 268 (41.5%) were >=65 years of age. Early clinical response (ECR) rates in the subgroup of patients >=65 were similar to ECR rates in subjects <65 years of age and comparable across treatment groups (XENLETA versus moxifloxacin).The adverse reaction profiles in patients >=65 years and in patients <65 years of age were similar. The percentage of patients in the XENLETA group who had at least one adverse reaction was 30%","Paediatric use":"The safety and effectiveness of XENLETA in patients less than 18 years of age has not yet been established."},"seriousAdverseEvents":[{"effect":"Serious adverse reactions (overall)","drugRate":"5.6%","severity":"serious"},{"effect":"Death within 28 days","drugRate":"1.2%","severity":"serious"},{"effect":"Clostridioides difficile colitis","drugRate":"","severity":"serious"},{"effect":"QT prolongation","drugRate":"","severity":"serious"},{"effect":"Atrial fibrillation","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Hong Kong","patents":[{"applNo":"N211673","source":"FDA Orange Book","status":"Active","expires":"Jun 14, 2036","useCode":"","territory":"US","drugProduct":true,"patentNumber":"12121582","drugSubstance":false},{"applNo":"N211673","source":"FDA Orange Book","status":"Active","expires":"Mar 25, 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the translocation of peptidyl-tRNA and thereby inhibiting protein synthesis, which is essential for bacterial growth and survival."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lefamulin","title":"Lefamulin","extract":"Lefamulin, sold under the brand name Xenleta, is an antibiotic medication used it to treat adults with community-acquired bacterial pneumonia. It is taken by mouth or by injection into a vein.","wiki_history":"==History==\nIt was developed by Nabriva Therapeutics and approved in the United States in 2019.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nLefamulin was approved for medical use in the United States in August 2019, and in the European Union in July 2020."},"commercial":{"launchDate":"2019","_launchSource":"DrugCentral (FDA 2019-08-19, NABRIVA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5348","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LEFAMULIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEFAMULIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lefamulin","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":"2026-03-30T12:16:53.942137","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:08:02.896751+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"fosfomycin","drugSlug":"fosfomycin","fdaApproval":"1996-12-19","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"spectinomycin","drugSlug":"spectinomycin","fdaApproval":"1971-06-30","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"methenamine","drugSlug":"methenamine","fdaApproval":"1967-07-05","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"linezolid","drugSlug":"linezolid","fdaApproval":"2000-04-18","genericCount":24,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"daptomycin","drugSlug":"daptomycin","fdaApproval":"2003-09-12","patentExpiry":"Sep 4, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"bacitracin","drugSlug":"bacitracin","fdaApproval":"1948-07-29","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"tedizolid phosphate","drugSlug":"tedizolid-phosphate","fdaApproval":"2014-06-20","patentExpiry":"Jun 20, 2028","patentStatus":"Patent protected","relationship":"same-class"}],"exclusivity":[{"code":"NCE","date":"Aug 19, 2024"},{"code":"GAIN","date":"Aug 19, 2029"}],"genericName":"lefamulin","indications":{"approved":[{"name":"Bacterial pneumonia","source":"DrugCentral","snomedId":53084003,"regulator":"FDA"},{"name":"Bronchopneumonia due to Haemophilus influenzae","source":"DrugCentral","snomedId":10625231000119106,"regulator":"FDA","eligibility":"Adults"},{"name":"Haemophilus influenzae pneumonia","source":"DrugCentral","snomedId":70036007,"regulator":"FDA","eligibility":"Adults"},{"name":"Legionella pneumonia","source":"DrugCentral","snomedId":195889001,"regulator":"FDA","eligibility":"Adults"},{"name":"Pneumonia caused by Chlamydia pneumoniae","source":"DrugCentral","snomedId":724498004,"regulator":"FDA","eligibility":"Adults"},{"name":"Pneumonia due to Mycoplasma pneumoniae","source":"DrugCentral","snomedId":46970008,"regulator":"FDA","eligibility":"Adults"},{"name":"Pneumonia due to Staphylococcus aureus","source":"DrugCentral","snomedId":441658007,"regulator":"FDA","eligibility":"Adults"},{"name":"Pneumonia due to Streptococcus","source":"DrugCentral","snomedId":34020007,"regulator":"FDA","eligibility":"Adults"}],"offLabel":[],"pipeline":[]},"currentOwner":"Hong Kong","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"fosfomycin","brandName":"fosfomycin","genericName":"fosfomycin","approvalYear":"1996","relationship":"same-class"},{"drugId":"spectinomycin","brandName":"spectinomycin","genericName":"spectinomycin","approvalYear":"1971","relationship":"same-class"},{"drugId":"methenamine","brandName":"methenamine","genericName":"methenamine","approvalYear":"1967","relationship":"same-class"},{"drugId":"linezolid","brandName":"linezolid","genericName":"linezolid","approvalYear":"2000","relationship":"same-class"},{"drugId":"daptomycin","brandName":"daptomycin","genericName":"daptomycin","approvalYear":"2003","relationship":"same-class"},{"drugId":"bacitracin","brandName":"bacitracin","genericName":"bacitracin","approvalYear":"1948","relationship":"same-class"},{"drugId":"tedizolid-phosphate","brandName":"tedizolid phosphate","genericName":"tedizolid phosphate","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05111002","phase":"PHASE1,PHASE2","title":"Lefamulin for M. 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