{"id":"retapamulin","rwe":[],"tags":[{"label":"Pleuromutilin Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D06AX13","category":"atc"},{"label":"Topical","category":"route"},{"label":"Ointment","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Impetigo","category":"indication"},{"label":"Superficial bacterial infection of skin","category":"indication"},{"label":"Almirall","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":103.468,"date":"","count":14,"signal":"Application site irritation","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=103)"}],"commonSideEffects":[{"effect":"Headache","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Application site irritation","drugRate":"1.6%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"1.2%","severity":"common","organSystem":""},{"effect":"Nasopharyngitis","drugRate":"1.5%","severity":"common","organSystem":""},{"effect":"Application site pruritus","drugRate":"1.9%","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"1.5%","severity":"common","organSystem":""},{"effect":"Eczema","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"1.2%","severity":"common","organSystem":""}],"contraindications":["Skin irritation"],"specialPopulations":{"Lactation":"There are no data available on the presence of retapamulin in human milk, its effects on the breastfed infant or its effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the negligible systemic absorption of retapamulin in humans following topical administration of ALTABAX.","Pregnancy":"There are no available data on ALTABAX use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Retapamulin is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the retapamulin. Animal reproduction studies were not conducted with ALTABAX.","Geriatric use":"Of the total number of subjects in the adequate and well-controlled trials of ALTABAX, 234 subjects were aged 65 years and older, of whom 114 subjects were aged 75 years and older. No overall differences in effectiveness or safety were observed between these subjects and younger adult subjects.","Paediatric use":"The safety and effectiveness of ALTABAX in the treatment of impetigo have been established in pediatric patients aged 9 months to 17 years."},"seriousAdverseEvents":[{"effect":"Creatinine phosphokinase increased","drugRate":"1%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Almirall","patents":[{"applNo":"N022055","source":"FDA Orange Book","status":"Active","expires":"Feb 14, 2027","useCode":"","territory":"US","drugProduct":false,"patentNumber":"7875630","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=RETAPAMULIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:14:35.866925+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:14:35.866830+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:14:42.163424+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:14:35.889499+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=RETAPAMULIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:14:42.976407+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: 70S ribosome inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:14:43.544085+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1658/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:14:43.440097+00:00"}},"allNames":"altabax","offLabel":[],"synonyms":["retapamulin","altabax","altargo","mutilin","retpamulin","SB275833","SB-275833"],"timeline":[{"date":"2007-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from GLAXO GRP LTD to Almirall"},{"date":"2007-04-12","type":"positive","source":"DrugCentral","milestone":"FDA approval (Glaxo Grp Ltd)"},{"date":"2007-05-24","type":"positive","source":"DrugCentral","milestone":"EMA approval"},{"date":"2027-02-14","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 7875630 expires"}],"aiSummary":"Altabax (Retapamulin) is a pleuromutilin antibacterial small molecule developed by Glaxo Group Ltd and currently owned by Almirall. It was FDA-approved in 2007 for the treatment of impetigo and superficial bacterial skin infections. Altabax works by inhibiting protein synthesis in bacteria, ultimately leading to bacterial cell death. It is a patented medication with no generic manufacturers available. Key safety considerations include potential skin irritation and allergic reactions.","approvals":[{"date":"2007-04-12","orphan":false,"company":"GLAXO GRP LTD","regulator":"FDA"},{"date":"2007-05-24","orphan":false,"company":"","regulator":"EMA"}],"brandName":"Altabax","ecosystem":[{"indication":"Impetigo","otherDrugs":[{"name":"cefuroxime","slug":"cefuroxime","company":"Covis Injectables"},{"name":"cefuroxime axetil","slug":"cefuroxime-axetil","company":"Glaxosmithkline"},{"name":"mupirocin","slug":"mupirocin","company":"Glaxosmithkline"}],"globalPrevalence":null},{"indication":"Superficial bacterial infection of skin","otherDrugs":[{"name":"ozenoxacin","slug":"ozenoxacin","company":"Ferrer Internacional S.A."}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Pleuromutilin Antibacterial","explanation":"","oneSentence":"","technicalDetail":"Altabax binds to the 50S subunit of the bacterial ribosome, specifically targeting the L16 protein, and inhibits the translocation step of protein synthesis, ultimately leading to the degradation of the bacterial mRNA and the inhibition of protein synthesis."},"commercial":{"launchDate":"2007","_launchSource":"DrugCentral (FDA 2007-04-12, GLAXO GRP LTD)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2371","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=RETAPAMULIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=RETAPAMULIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"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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