{"id":"roxithromycin","rwe":[{"pmid":"41883371","year":"2026","title":"Antibiotic Exposure and Early Reproductive Outcomes of In Vitro Fertilization (IVF) in a Chinese Couple-Based Preconception Cohort.","finding":"","journal":"Environment & health (Washington, D.C.)","studyType":"Clinical Study"},{"pmid":"41873606","year":"2026","title":"Target-Induced DNA Nanodevice as Efficient Signal Amplification Strategy Coupled with a Regenerable SERS Substrate HOF@Au for Ultrasensitive Detection of Roxithromycin.","finding":"","journal":"Analytical chemistry","studyType":"Clinical Study"},{"pmid":"41843962","year":"2026","title":"Ultrahigh performance liquid chromatography mass spectrometry for the determination of azithromycin in canine serum and skin tissue.","finding":"","journal":"Journal of chromatography. B, Analytical technologies in the biomedical and life sciences","studyType":"Clinical Study"},{"pmid":"41839799","year":"2026","title":"Comparative evaluation of zein and gliadin as encapsulant materials for antimicrobial delivery: A thermokinetic study.","finding":"","journal":"Journal of the science of food and agriculture","studyType":"Clinical Study"},{"pmid":"41808863","year":"2026","title":"Network meta-analysis of pharmacological treatments for idiopathic pulmonary fibrosis: evaluating effects on lung function.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"}],"tags":[{"label":"roxithromycin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Motilin receptor","category":"target"},{"label":"MLNR","category":"gene"},{"label":"J01FA06","category":"atc"},{"label":"Active","category":"status"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":42.889,"date":"","count":20,"signal":"Jaundice","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=43)"},{"llr":36.201,"date":"","count":19,"signal":"Drug-induced liver injury","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=36)"},{"llr":35.699,"date":"","count":39,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=36)"},{"llr":30.969,"date":"","count":12,"signal":"Myopathy","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=31)"}],"commonSideEffects":[{"effect":"Jaundice","drugRate":"LLR 43","severity":"common"},{"effect":"Drug-induced liver injury","drugRate":"LLR 36","severity":"common"},{"effect":"Drug interaction","drugRate":"LLR 36","severity":"common"},{"effect":"Myopathy","drugRate":"LLR 31","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"roxacin","offLabel":[],"synonyms":["roxithromycin","rotramin","claramid","roxacin","roxeptin","Roxithromycin A"],"timeline":[{"date":"1987-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"aiSummary":"Roxithromycin, also known as Roxacin, is a small molecule antibiotic drug that targets the motilin receptor. It belongs to the macrolide class of antibiotics and is used to treat various bacterial infections. However, its commercial status and approved indications are unknown. As a macrolide antibiotic, roxithromycin works by inhibiting protein synthesis in bacteria, ultimately leading to their death. Further information on its pharmacokinetics and safety profile is needed.","approvals":[{"date":"1987-01-01","orphan":false,"company":"","regulator":"YEAR INTRODUCED"}],"brandName":"Roxacin","ecosystem":[],"mechanism":{"target":"Motilin receptor, 50S ribosomal protein L10, Alpha-1B adrenergic receptor","targets":[{"gene":"MLNR","source":"DrugCentral","target":"Motilin receptor","protein":"Motilin receptor"}],"modality":"Small Molecule","drugClass":"roxithromycin","explanation":"Imagine your body's cells are like factories that make proteins to keep you healthy. Bacteria are like tiny factories that make proteins to harm you. Roxithromycin is like a key that locks the bacterial factory, preventing it from making proteins and ultimately killing the bacteria.","oneSentence":"Roxithromycin works by binding to the bacterial ribosome and inhibiting protein synthesis.","technicalDetail":"Roxithromycin binds to the 50S subunit of the bacterial ribosome, specifically to the motilin receptor, and inhibits the translocation step of protein synthesis, leading to the accumulation of misfolded proteins and ultimately bacterial cell death."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2410","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ROXITHROMYCIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ROXITHROMYCIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:34:23.883830","biosimilars":[],"competitors":[{"drugName":"erythromycin","drugSlug":"erythromycin","fdaApproval":"1964-06-24","genericCount":39,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"troleandomycin","drugSlug":"troleandomycin","fdaApproval":"1969-05-27","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"clarithromycin","drugSlug":"clarithromycin","fdaApproval":"1991-10-31","genericCount":20,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"azithromycin","drugSlug":"azithromycin","fdaApproval":"1991-11-01","genericCount":31,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"dirithromycin","drugSlug":"dirithromycin","fdaApproval":"1995-06-19","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"telithromycin","drugSlug":"telithromycin","fdaApproval":"2004-04-01","patentStatus":"Unknown","relationship":"same-class"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"roxithromycin","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"erythromycin","brandName":"erythromycin","genericName":"erythromycin","approvalYear":"1964","relationship":"same-class"},{"drugId":"troleandomycin","brandName":"troleandomycin","genericName":"troleandomycin","approvalYear":"1969","relationship":"same-class"},{"drugId":"clarithromycin","brandName":"clarithromycin","genericName":"clarithromycin","approvalYear":"1991","relationship":"same-class"},{"drugId":"azithromycin","brandName":"azithromycin","genericName":"azithromycin","approvalYear":"1991","relationship":"same-class"},{"drugId":"dirithromycin","brandName":"dirithromycin","genericName":"dirithromycin","approvalYear":"1995","relationship":"same-class"},{"drugId":"telithromycin","brandName":"telithromycin","genericName":"telithromycin","approvalYear":"2004","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06798051","phase":"PHASE1","title":"Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects","status":"COMPLETED","sponsor":"The Affiliated Hospital Of Guizhou Medical University","startDate":"2019-06-03","conditions":["Bioequivalence of Roxithromycin Tablets From Two Different Manufacturers"],"enrollment":39,"completionDate":"2019-09-03"},{"nctId":"NCT02735707","phase":"PHASE3","title":"Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia","status":"RECRUITING","sponsor":"UMC Utrecht","startDate":"2016-04-11","conditions":["Community-acquired Pneumonia, Influenza, COVID-19"],"enrollment":20000,"completionDate":"2028-02"},{"nctId":"NCT04122040","phase":"PHASE3","title":"Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis","status":"COMPLETED","sponsor":"Prince of Songkla University","startDate":"2011-03-01","conditions":["Quality of Life","Respiratory Function Tests"],"enrollment":40,"completionDate":"2011-09-30"},{"nctId":"NCT03571230","phase":"PHASE4","title":"Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.","status":"UNKNOWN","sponsor":"Shandong University","startDate":"2018-07-01","conditions":["Helicobacter Pylori Infection","Antimicrobial Susceptibility Testing"],"enrollment":400,"completionDate":"2020-01-30"},{"nctId":"NCT03414918","phase":"NA","title":"Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA)","status":"UNKNOWN","sponsor":"University Hospital Padova","startDate":"2018-03","conditions":["Hyperaldosteronism"],"enrollment":342,"completionDate":"2020-01"},{"nctId":"NCT03148444","phase":"PHASE4","title":"Impact of Antibiotic Treatment Following Implantation of Cardiac Electronic Device on Patient's Outcome","status":"UNKNOWN","sponsor":"Kaplan Medical Center","startDate":"2017-06-01","conditions":["Infection, Bacterial","Pacemaker Complication"],"enrollment":400,"completionDate":"2020-06-01"},{"nctId":"NCT02819570","phase":"PHASE4","title":"Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes","status":"UNKNOWN","sponsor":"Western Galilee Hospital-Nahariya","startDate":"2015-11","conditions":["Premature Rupture of Membrane"],"enrollment":400,"completionDate":"2017-12"},{"nctId":"NCT01843946","phase":"","title":"Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome","status":"COMPLETED","sponsor":"The Catholic University of Korea","startDate":"2011-03","conditions":["Chronic Prostatitis","Chronic Pelvic Pain Syndrome"],"enrollment":75,"completionDate":"2012-07"},{"nctId":"NCT00197379","phase":"NA","title":"The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia","status":"UNKNOWN","sponsor":"Hamamatsu University","startDate":"2005-05","conditions":["Alopecia"],"enrollment":20,"completionDate":"2007-01"},{"nctId":"NCT00621387","phase":"NA","title":"Study of Long-Term Antibiotic Treatment in Reactive Arthritis","status":"COMPLETED","sponsor":"University of Helsinki","startDate":"1993-11","conditions":["Reactive Arthritis"],"enrollment":56,"completionDate":"1998-06"},{"nctId":"NCT00439062","phase":"PHASE4","title":"Treatment of Rheumatoid Arthritis With Roxithromycin","status":"COMPLETED","sponsor":"Nazilli State Hospital","startDate":"2006-06","conditions":["Rheumatoid Arthritis"],"enrollment":100,"completionDate":"2006-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"NUI":"N0000168422","NDDF":"004199","UNII":"21KOF230FA","CHEBI":"CHEBI:48935","INN_ID":"5815","RXNORM":"9478","UMLSCUI":"C0035891","ChEMBL_ID":"CHEMBL1214185","KEGG_DRUG":"D01710","DRUGBANK_ID":"DB00778","PDB_CHEM_ID":" ROX","PUBCHEM_CID":"6915744","SNOMEDCT_US":"713769006","IUPHAR_LIGAND_ID":"1465","MESH_DESCRIPTOR_UI":"D015575"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"50%"},"publicationCount":1611,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J01FA06","allCodes":["J01FA06"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 20","pmid":"41883371","title":"Antibiotic Exposure and Early Reproductive Outcomes of In Vitro Fertilization (IVF) in a Chinese Couple-Based Preconception Cohort.","journal":"Environment & health (Washington, D.C.)"},{"date":"2026 Mar 24","pmid":"41873606","title":"Target-Induced DNA Nanodevice as Efficient Signal Amplification Strategy Coupled with a Regenerable SERS Substrate HOF@Au for Ultrasensitive Detection of Roxithromycin.","journal":"Analytical chemistry"},{"date":"2026 Mar 11","pmid":"41843962","title":"Ultrahigh performance liquid chromatography mass spectrometry for the determination of azithromycin in canine serum and skin tissue.","journal":"Journal of chromatography. 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