{"id":"astodrimer","rwe":[{"pmid":"39339209","year":"2024","title":"Astodrimer Sodium Nasal Spray versus Placebo in Non-Hospitalised Patients with COVID-19: A Randomised, Double-Blinded, Placebo-Controlled Trial.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"39261670","year":"2024","title":"Astodrimer sodium nasal spray forms a barrier to SARS-CoV-2 in vitro and preserves normal mucociliary function in human nasal epithelium.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"35715644","year":"2022","title":"Astodrimer sodium antiviral nasal spray for reducing respiratory infections is safe and well tolerated in a randomized controlled trial.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"35246717","year":"2022","title":"Astodrimer sodium and bacterial vaginosis: a mini review.","finding":"","journal":"Archives of gynecology and obstetrics","studyType":"Clinical Study"},{"pmid":"34452519","year":"2021","title":"Protective Effects of Astodrimer Sodium 1% Nasal Spray Formulation against SARS-CoV-2 Nasal Challenge in K18-hACE2 Mice.","finding":"","journal":"Viruses","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Antimicrobial substance","category":"indication"}],"phase":"phase_3","safety":{"commonSideEffects":[{"effect":"Vulvovaginal candidiasis","drugRate":"16.0%","placeboRate":"","totalAtRisk":294,"totalAffected":47,"trialsReporting":1},{"effect":"UTI","drugRate":"9.5%","placeboRate":"","totalAtRisk":294,"totalAffected":28,"trialsReporting":1},{"effect":"Headache","drugRate":"5.8%","placeboRate":"","totalAtRisk":294,"totalAffected":17,"trialsReporting":1},{"effect":"Vulvovaginal mycotic infection","drugRate":"4.8%","placeboRate":"","totalAtRisk":294,"totalAffected":14,"trialsReporting":1},{"effect":"Nasopharyngitis","drugRate":"3.1%","placeboRate":"","totalAtRisk":294,"totalAffected":9,"trialsReporting":1}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:33:02.006320","allNames":["astodrimer","astodrimer sodium","SPL7013","SPL 7013","SPL-7013","BRI7013","BRI-7013"],"offLabel":[],"synonyms":["astodrimer","astodrimer sodium","SPL7013","SPL 7013","SPL-7013","BRI7013","BRI-7013"],"timeline":[],"ecosystem":[{"indication":"Antimicrobial substance","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"Imagine your body is like a garden, and microorganisms are like weeds. ASTODRIMER is like a special kind of herbicide that helps to kill or prevent the growth of these weeds, keeping your body healthy and free from infection.","oneSentence":"ASTODRIMER works by interfering with the growth and replication of microorganisms.","technicalDetail":"ASTODRIMER's exact mechanism of action is not well-documented, but it is thought to involve the inhibition of certain cellular processes that are essential for microorganism growth and replication."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5050","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ASTODRIMER","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ASTODRIMER","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:46:26.954028","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:42:11.144259+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"astodrimer","indications":{"approved":[{"name":"Antimicrobial substance","source":"DrugCentral","snomedId":250428009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(11)"],"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02237950","phase":"PHASE3","title":"Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2014-10-13","conditions":["Bacterial Vaginosis"],"enrollment":586,"completionDate":"2017-02-22"},{"nctId":"NCT01577238","phase":"PHASE3","title":"A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2012-03-28","conditions":["Bacterial Vaginosis"],"enrollment":250,"completionDate":"2012-07-20"},{"nctId":"NCT01577537","phase":"PHASE3","title":"A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2012-04-17","conditions":["Bacterial Vaginosis"],"enrollment":251,"completionDate":"2012-10-05"},{"nctId":"NCT01201057","phase":"PHASE2","title":"Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2010-08","conditions":["Bacterial Vaginosis"],"enrollment":132,"completionDate":"2011-05"},{"nctId":"NCT00740584","phase":"PHASE1,PHASE2","title":"Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2008-08","conditions":["HIV Infections","HSV-2 Genital Herpes"],"enrollment":12,"completionDate":"2009-03"},{"nctId":"NCT02236156","phase":"PHASE3","title":"Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2014-10-03","conditions":["Bacterial Vaginosis"],"enrollment":637,"completionDate":"2016-10-04"},{"nctId":"NCT00490152","phase":"","title":"Microbicides Acceptability Among Sexually Active Young Women","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2007-08","conditions":["HIV Infections"],"enrollment":59,"completionDate":"2009-11"},{"nctId":"NCT01437722","phase":"PHASE2","title":"Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2011-08","conditions":["Recurrent Bacterial Vaginosis (BV)"],"enrollment":205,"completionDate":""},{"nctId":"NCT00331032","phase":"PHASE1","title":"VivaGel™ in Healthy Young Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2006-12","conditions":["Herpes Simplex II"],"enrollment":56,"completionDate":"2007-11"},{"nctId":"NCT00442910","phase":"PHASE1","title":"Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2007-07","conditions":["Healthy"],"enrollment":61,"completionDate":"2009-12"},{"nctId":"NCT00370357","phase":"PHASE1","title":"SPL7013 Gel - Male Tolerance Study","status":"COMPLETED","sponsor":"Starpharma Pty Ltd","startDate":"2006-08","conditions":["Human Immunodeficiency Virus (HIV)"],"enrollment":36,"completionDate":"2007-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"F8H3J9KSY9","INN_ID":"9770","UMLSCUI":"C4490518","ChEMBL_ID":"CHEMBL2364665","DRUGBANK_ID":"DB11854","MESH_SUPPLEMENTAL_RECORD_UI":"C480351"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":11,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"recentPublications":[{"date":"2024 Sep 6","pmid":"39339209","title":"Astodrimer Sodium Nasal Spray versus Placebo in Non-Hospitalised Patients with COVID-19: A Randomised, Double-Blinded, Placebo-Controlled Trial.","journal":"Pharmaceutics"},{"date":"2024 Sep 11","pmid":"39261670","title":"Astodrimer sodium nasal spray forms a barrier to SARS-CoV-2 in vitro and preserves normal mucociliary function in human nasal epithelium.","journal":"Scientific reports"},{"date":"2022 Jun 17","pmid":"35715644","title":"Astodrimer sodium antiviral nasal spray for reducing respiratory infections is safe and well tolerated in a randomized controlled trial.","journal":"Scientific reports"},{"date":"2022 Jul","pmid":"35246717","title":"Astodrimer sodium and bacterial vaginosis: a mini review.","journal":"Archives of gynecology and obstetrics"},{"date":"2021 Aug 20","pmid":"34452519","title":"Protective Effects of Astodrimer Sodium 1% Nasal Spray Formulation against SARS-CoV-2 Nasal Challenge in K18-hACE2 Mice.","journal":"Viruses"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"ASTODRIMER","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ASTODRIMER is a small molecule drug with antimicrobial properties. Its exact mechanism of action is not well-documented, but it is known to be effective against certain microorganisms. ASTODRIMER is approved for use as an antimicrobial substance, but its target and drug class are unknown. The commercial status of ASTODRIMER is unclear, and it is not known whether it is patented or available as a generic product. Further research is needed to fully understand the safety and efficacy of ASTODRIMER.","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":4,"withResults":3},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:42:11.144259+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}