{"id":"spiramycin","rwe":[],"tags":[{"label":"spiramycin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01FA02","category":"atc"},{"label":"Active","category":"status"},{"label":"Prophylaxis of congenital toxoplasmosis","category":"indication"},{"label":"Sanofi KK","category":"company"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiprotozoal Agents","category":"pharmacology"},{"label":"Coccidiostats","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":260.043,"date":"","count":84,"signal":"Hepatocellular injury","source":"DrugCentral FAERS","actionTaken":"Reported 84 times (LLR=260)"},{"llr":234.223,"date":"","count":80,"signal":"Cholestasis","source":"DrugCentral FAERS","actionTaken":"Reported 80 times (LLR=234)"},{"llr":168.191,"date":"","count":64,"signal":"Rash maculo-papular","source":"DrugCentral FAERS","actionTaken":"Reported 64 times (LLR=168)"},{"llr":159.544,"date":"","count":58,"signal":"Toxic epidermal necrolysis","source":"DrugCentral FAERS","actionTaken":"Reported 58 times (LLR=160)"},{"llr":97.787,"date":"","count":45,"signal":"Drug reaction with eosinophilia and systemic symptoms","source":"DrugCentral FAERS","actionTaken":"Reported 45 times (LLR=98)"},{"llr":95.5,"date":"","count":31,"signal":"Acute generalised exanthematous pustulosis","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=96)"},{"llr":91.256,"date":"","count":39,"signal":"Eosinophilia","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=91)"},{"llr":84.972,"date":"","count":26,"signal":"Hypertransaminasaemia","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=85)"},{"llr":66.287,"date":"","count":41,"signal":"Rhabdomyolysis","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=66)"},{"llr":62.254,"date":"","count":43,"signal":"Septic shock","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=62)"},{"llr":49.77,"date":"","count":33,"signal":"Lung disorder","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=50)"},{"llr":47.788,"date":"","count":17,"signal":"Rash pustular","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=48)"},{"llr":47.653,"date":"","count":28,"signal":"Respiratory distress","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=48)"},{"llr":45.657,"date":"","count":13,"signal":"Premature rupture of membranes","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=46)"},{"llr":43.854,"date":"","count":20,"signal":"Hepatic cytolysis","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=44)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Sanofi KK","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SPIRAMYCIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:19:34.891863+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:19:58.228192+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:19:48.368317+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SPIRAMYCIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:19:49.275909+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial 70S ribosome inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:19:49.864924+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL453514/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:19:49.753581+00:00"}},"allNames":"rovamycin","offLabel":[],"synonyms":["spiramycin","espiramicin","foromacidin","provamycin","rovamicina","rovamycin","rovamycine","selectomycin","sequamycin","spiramycins","stomamycin"],"timeline":[{"date":"2018-07-02","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Sanofi KK)"}],"aiSummary":"Spiramycin (Rovamycin), marketed by Sanofi KK, is positioned in the niche but critical area of prophylaxis for congenital toxoplasmosis. Its key strength lies in its unique mechanism of action, inhibiting bacterial protein synthesis, which differentiates it from other macrolides such as erythromycin and clarithromycin. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.","approvals":[{"date":"2018-07-02","orphan":true,"company":"Sanofi KK","regulator":"PMDA"}],"brandName":"Rovamycin","ecosystem":[{"indication":"Prophylaxis of congenital toxoplasmosis","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"spiramycin","explanation":"","oneSentence":"","technicalDetail":"Spiramycin is a macrolide antibiotic that binds to the 50S subunit of the bacterial ribosome, inhibiting peptide bond formation and thus preventing protein synthesis."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4711","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SPIRAMYCIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SPIRAMYCIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:42:59.554131","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:19:58.229144+00:00","fieldsConflicting":2,"overallConfidence":0.8},"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"}],"genericName":"spiramycin","indications":{"approved":[{"name":"Prophylaxis of congenital toxoplasmosis","source":"DrugCentral","snomedId":73893000,"regulator":"FDA"}],"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":"NCT03641690","phase":"","title":"Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2013-09-01","conditions":["H1N1 Influenza"],"enrollment":97,"completionDate":"2017-12-01"},{"nctId":"NCT01189448","phase":"PHASE3","title":"Prevention of Congenital Toxoplasmosis With Pyrimethamine + Sulfadiazine Versus Spiramycine During Pregnancy","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2010-11","conditions":["Congenital Toxoplasmosis"],"enrollment":149,"completionDate":"2016-04"},{"nctId":"NCT00004317","phase":"PHASE4","title":"Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2000-07","conditions":["Toxoplasmosis"],"enrollment":600,"completionDate":"2030-12"},{"nctId":"NCT00002062","phase":"NA","title":"Open-Label \"Compassionate\" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients","status":"COMPLETED","sponsor":"Rhone-Poulenc Rorer","startDate":"","conditions":["Cryptosporidiosis","HIV Infections"],"enrollment":0,"completionDate":""},{"nctId":"NCT00000980","phase":"PHASE1","title":"A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea","status":"COMPLETED","sponsor":"Rhone-Poulenc Rorer","startDate":"","conditions":["Cryptosporidiosis","HIV Infections"],"enrollment":25,"completionDate":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000168428","NDDF":"002766","UNII":"71ODY0V87H","CHEBI":"CHEBI:85260","INN_ID":"478","RXNORM":"9991","UMLSCUI":"C0037962","chemblId":"CHEMBL453514","ChEMBL_ID":"CHEMBL453514","KEGG_DRUG":"D05908","DRUGBANK_ID":"DB06145","PUBCHEM_CID":"6440717","SNOMEDCT_US":"302007","MESH_DESCRIPTOR_UI":"D015572"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Sanofi KK","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"5.2 hours","clearance":"12.8 mL/min/kg","bioavailability":"35%","fractionUnbound":"0.26%","volumeOfDistribution":"5.4 L/kg"},"publicationCount":1509,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J01FA02","allCodes":["J01FA02","J01RA04"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Sanofi KK","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2018-07-02T00:00:00.000Z","mah":"Sanofi KK","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:19:58.229144+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}