{"id":"mirodenafil","rwe":[{"pmid":"41352712","year":"2026","title":"Protective effects of phosphodiesterase 5 inhibitor, mirodenafil, on traumatic brain injury-induced neuronal death.","finding":"","journal":"Neuropharmacology","studyType":"Clinical Study"},{"pmid":"40912996","year":"2025","title":"A phase 2 randomized, placebo-controlled study on the efficacy and safety of AR1001, a phosphodiesterase-5 inhibitor, in patients with mild-to-moderate Alzheimer's disease.","finding":"","journal":"The journal of prevention of Alzheimer's disease","studyType":"Clinical Study"},{"pmid":"40443793","year":"2025","title":"Mirodenafil improves cognitive function by reducing microglial activation and blood-brain barrier permeability in ApoE4 KI mice.","finding":"","journal":"Frontiers in aging neuroscience","studyType":"Clinical Study"},{"pmid":"39393981","year":"2025","title":"Therapeutic effects of mirodenafil, a phosphodiesterase 5 inhibitor, on stroke models in rats.","finding":"","journal":"Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics","studyType":"Clinical Study"},{"pmid":"39096237","year":"2024","title":"An overview of conventional and investigational phosphodiesterase 5 inhibitors for treating erectile dysfunction and other conditions.","finding":"","journal":"Expert opinion on investigational drugs","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"cGMP-specific 3',5'-cyclic phosphodiesterase","category":"target"},{"label":"PDE5A","category":"gene"},{"label":"Active","category":"status"},{"label":"Impotence","category":"indication"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Phosphodiesterase 5 Inhibitors","category":"pharmacology"},{"label":"Phosphodiesterase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MIRODENAFIL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:59:41.160441+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:59:57.410647+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:59:47.861498+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MIRODENAFIL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:59:48.627428+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297518/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:59:49.121645+00:00"}},"allNames":"mvix","offLabel":[],"synonyms":["mirodenafil","mvix","SK3530","mirodenafil dihydrochloride"],"timeline":[{"date":"2007-07-18","type":"positive","source":"DrugCentral","milestone":"Korean Food and Drug Administration (KFDA) approval"}],"aiSummary":"Mirodenafil (Mvix) is a marketed drug indicated for impotence, operating through the inhibition of an enzyme that allows for increased blood flow. Its key competitive advantage lies in its unique mechanism of action and the protection offered by its key composition patent, which does not expire until 2028. The primary risk to Mirodenafil's market position is the presence of off-patent competitors such as avanafil and dipyridamole, which are already available as generics.","approvals":[{"date":"2007-07-18","orphan":false,"company":"","regulator":"Korean Food and Drug Administration (KFDA)"}],"brandName":"Mvix","ecosystem":[{"indication":"Impotence","otherDrugs":[{"name":"alprostadil","slug":"alprostadil","company":"Pharmacia And Upjohn"},{"name":"avanafil","slug":"avanafil","company":"Vivus"},{"name":"sildenafil","slug":"sildenafil","company":"Pfizer Ireland"},{"name":"tadalafil","slug":"tadalafil","company":"Lilly"}],"globalPrevalence":null}],"mechanism":{"target":"cGMP-specific 3',5'-cyclic phosphodiesterase","targets":[{"gene":"PDE5A","source":"DrugCentral","target":"cGMP-specific 3',5'-cyclic phosphodiesterase","protein":"cGMP-specific 3',5'-cyclic phosphodiesterase"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Mvix specifically targets the phosphodiesterase type 5 (PDE5) enzyme, which is responsible for breaking down cGMP in the smooth muscle cells of the corpus cavernosum, leading to increased blood flow and penile erection."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5005","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MIRODENAFIL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MIRODENAFIL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T14:32:28.526111","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T01:59:57.411021+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"avanafil","drugSlug":"avanafil","fdaApproval":"2012-04-27","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"celecoxib","drugSlug":"celecoxib","fdaApproval":"1998-12-31","patentExpiry":"May 27, 2036","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"dipyridamole","drugSlug":"dipyridamole","fdaApproval":"1961-12-06","genericCount":17,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"milrinone","drugSlug":"milrinone","fdaApproval":"1987-12-31","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"papaverine","drugSlug":"papaverine","fdaApproval":"","relationship":"same-target"},{"drugName":"pentoxifylline","drugSlug":"pentoxifylline","fdaApproval":"1984-08-30","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"sildenafil","drugSlug":"sildenafil","fdaApproval":"1998-03-27","patentExpiry":"Dec 24, 2038","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"tadalafil","drugSlug":"tadalafil","fdaApproval":"2003-11-21","patentExpiry":"Dec 24, 2038","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"tannic acid","drugSlug":"tannic-acid","fdaApproval":"1980-02-02","relationship":"same-target"},{"drugName":"vardenafil","drugSlug":"vardenafil","fdaApproval":"2003-08-19","patentExpiry":"Jul 23, 2027","patentStatus":"Patent protected","relationship":"same-target"}],"genericName":"mirodenafil","indications":{"approved":[{"name":"Impotence","source":"DrugCentral","snomedId":397803000,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"avanafil","brandName":"avanafil","genericName":"avanafil","approvalYear":"2012","relationship":"same-target"},{"drugId":"celecoxib","brandName":"celecoxib","genericName":"celecoxib","approvalYear":"1998","relationship":"same-target"},{"drugId":"dipyridamole","brandName":"dipyridamole","genericName":"dipyridamole","approvalYear":"1961","relationship":"same-target"},{"drugId":"milrinone","brandName":"milrinone","genericName":"milrinone","approvalYear":"1987","relationship":"same-target"},{"drugId":"papaverine","brandName":"papaverine","genericName":"papaverine","approvalYear":"","relationship":"same-target"},{"drugId":"pentoxifylline","brandName":"pentoxifylline","genericName":"pentoxifylline","approvalYear":"1984","relationship":"same-target"},{"drugId":"sildenafil","brandName":"sildenafil","genericName":"sildenafil","approvalYear":"1998","relationship":"same-target"},{"drugId":"tadalafil","brandName":"tadalafil","genericName":"tadalafil","approvalYear":"2003","relationship":"same-target"},{"drugId":"tannic-acid","brandName":"tannic acid","genericName":"tannic acid","approvalYear":"1980","relationship":"same-target"},{"drugId":"vardenafil","brandName":"vardenafil","genericName":"vardenafil","approvalYear":"2003","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT01802359","phase":"","title":"A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction","status":"TERMINATED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2011-11-07","conditions":["Erectile Dysfunction"],"enrollment":379,"completionDate":"2012-05-31"},{"nctId":"NCT02485028","phase":"PHASE1","title":"Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg","status":"COMPLETED","sponsor":"SK Chemicals Co., Ltd.","startDate":"2013-10","conditions":["Drug Interaction Potentiation"],"enrollment":36,"completionDate":"2013-11"},{"nctId":"NCT02485041","phase":"PHASE1","title":"Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg","status":"COMPLETED","sponsor":"SK Chemicals Co., Ltd.","startDate":"2014-11","conditions":["Drug Interaction Potentiation"],"enrollment":36,"completionDate":"2014-12"},{"nctId":"NCT01232010","phase":"PHASE1","title":"Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients","status":"COMPLETED","sponsor":"Asan Medical Center","startDate":"2009-11","conditions":["Renal Insufficiency","Kidney Diseases","Urologic Diseases"],"enrollment":12,"completionDate":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"504G362H0H","CHEBI":"CHEBI:136049","INN_ID":"8776","UMLSCUI":"C2353244","chemblId":"CHEMBL4297518","ChEMBL_ID":"CHEMBL4297518","DRUGBANK_ID":"DB11792","PUBCHEM_CID":"135497803","IUPHAR_LIGAND_ID":"11738","SECONDARY_CAS_RN":"862189-96-6","MESH_SUPPLEMENTAL_RECORD_UI":"C528396"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":65,"therapeuticAreas":["Hematology"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 1","pmid":"41352712","title":"Protective effects of phosphodiesterase 5 inhibitor, mirodenafil, on traumatic brain injury-induced neuronal death.","journal":"Neuropharmacology"},{"date":"2025 Nov","pmid":"40912996","title":"A phase 2 randomized, placebo-controlled study on the efficacy and safety of AR1001, a phosphodiesterase-5 inhibitor, in patients with mild-to-moderate Alzheimer's disease.","journal":"The journal of prevention of Alzheimer's disease"},{"date":"2025","pmid":"40443793","title":"Mirodenafil improves cognitive function by reducing microglial activation and blood-brain barrier permeability in ApoE4 KI mice.","journal":"Frontiers in aging neuroscience"},{"date":"2025 Jan","pmid":"39393981","title":"Therapeutic effects of mirodenafil, a phosphodiesterase 5 inhibitor, on stroke models in rats.","journal":"Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics"},{"date":"2024 Sep","pmid":"39096237","title":"An overview of conventional and investigational phosphodiesterase 5 inhibitors for treating erectile dysfunction and other conditions.","journal":"Expert opinion on investigational drugs"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"OTHER","regulator":"Korean Food and Drug Administration (KFDA)","status":"approved","approval_date":"2007-07-18T00:00:00.000Z","mah":"","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":"2026-04-20T01:59:57.411021+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}