{"id":"butylphthalide","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Potassium channel subfamily K member 2","category":"target"},{"label":"KCNK2","category":"gene"},{"label":"Active","category":"status"},{"label":"Ischemic stroke","category":"indication"},{"label":"CSPC Ouyi Pharmaceutical","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":["3-n-Butylphthalide","NBP","DL-3-n-butylphthalide","dl-NBP","Blank"],"company":"CSPC Ouyi Pharmaceutical","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Butylphthalide","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:23:19.196691+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Butylphthalide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:23:27.359770+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:23:25.807543+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Butylphthalide","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:23:26.769352+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL248594/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:23:27.251721+00:00"}},"allNames":"3-butylphthalide","offLabel":[],"synonyms":["butylphthalide","3-Butylphthalide","N-Butylphthalide"],"timeline":[{"date":"2002-09-30","type":"positive","source":"DrugCentral","milestone":"China Food and Drug Administration (CFDA) approval (CSPC Ouyi Pharmaceutical)"}],"brandName":"3-Butylphthalide","ecosystem":[{"indication":"Ischemic stroke","otherDrugs":[{"name":"alteplase","slug":"alteplase","company":"Genentech"},{"name":"edaravone","slug":"edaravone","company":"Mitsubishi Tanabe Pharma Development America Inc"},{"name":"edoxaban","slug":"edoxaban","company":"Daiichi Sankyo"}],"globalPrevalence":null}],"mechanism":{"target":"Potassium channel subfamily K member 2","targets":[{"gene":"KCNK2","source":"DrugCentral","target":"Potassium channel subfamily K member 2","protein":"Potassium channel subfamily K member 2"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Butylphthalide acts as a selective blocker of the KCNK2 potassium channel, which plays a crucial role in the regulation of neuronal excitability and inflammation. By inhibiting this channel, Butylphthalide reduces the release of excitatory neurotransmitters and decreases the expression of pro-inflammatory cytokines, ultimately leading to neuroprotection and improved outcomes in ischemic stroke patients."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Butylphthalide","title":"Butylphthalide","extract":"Butylphthalide is one of the chemical constituents in celery oil, along with sedanolide, which is primarily responsible for the aroma and taste of celery."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5257","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Butylphthalide","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Butylphthalide","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Butylphthalide","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T09:09:58.295491","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:23:29.111854+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"amlodipine","drugSlug":"amlodipine","fdaApproval":"1992-07-31","patentExpiry":"Feb 24, 2041","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"carvedilol","drugSlug":"carvedilol","fdaApproval":"1995-09-14","genericCount":17,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"chlorpromazine","drugSlug":"chlorpromazine","fdaApproval":"1957-09-18","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"desflurane","drugSlug":"desflurane","fdaApproval":"1992-09-18","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"dofetilide","drugSlug":"dofetilide","fdaApproval":"1999-10-01","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"enflurane","drugSlug":"enflurane","fdaApproval":"1972-08-28","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"fluoxetine","drugSlug":"fluoxetine","fdaApproval":"1987-12-29","genericCount":49,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"fluphenazine","drugSlug":"fluphenazine","fdaApproval":"1959-09-09","genericCount":26,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"haloperidol","drugSlug":"haloperidol","fdaApproval":"1967-04-12","genericCount":20,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"halothane","drugSlug":"halothane","fdaApproval":"1958-03-12","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"}],"genericName":"butylphthalide","indications":{"approved":[{"name":"Ischemic stroke","source":"DrugCentral","snomedId":422504002,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"amlodipine","brandName":"amlodipine","genericName":"amlodipine","approvalYear":"1992","relationship":"same-target"},{"drugId":"carvedilol","brandName":"carvedilol","genericName":"carvedilol","approvalYear":"1995","relationship":"same-target"},{"drugId":"chlorpromazine","brandName":"chlorpromazine","genericName":"chlorpromazine","approvalYear":"1957","relationship":"same-target"},{"drugId":"desflurane","brandName":"desflurane","genericName":"desflurane","approvalYear":"1992","relationship":"same-target"},{"drugId":"dofetilide","brandName":"dofetilide","genericName":"dofetilide","approvalYear":"1999","relationship":"same-target"},{"drugId":"enflurane","brandName":"enflurane","genericName":"enflurane","approvalYear":"1972","relationship":"same-target"},{"drugId":"fluoxetine","brandName":"fluoxetine","genericName":"fluoxetine","approvalYear":"1987","relationship":"same-target"},{"drugId":"fluphenazine","brandName":"fluphenazine","genericName":"fluphenazine","approvalYear":"1959","relationship":"same-target"},{"drugId":"haloperidol","brandName":"haloperidol","genericName":"haloperidol","approvalYear":"1967","relationship":"same-target"},{"drugId":"halothane","brandName":"halothane","genericName":"halothane","approvalYear":"1958","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT03804229","phase":"PHASE3","title":"Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Capital Medical University","startDate":"2019-10-29","conditions":["Vascular Dementia"],"enrollment":707,"completionDate":"2026-06-07"},{"nctId":"NCT07369999","phase":"PHASE3","title":"Effects of Butylphthalide Enhanced With Tenecteplase on Neurological Function in Mild Disabling Acute Ischemic Stroke","status":"NOT_YET_RECRUITING","sponsor":"Xiangya Hospital of Central South University","startDate":"2026-02-01","conditions":["Mild Disabling Acute Ischemic Stroke"],"enrollment":1062,"completionDate":"2029-06-30"},{"nctId":"NCT07252544","phase":"PHASE3","title":"Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-12-01","conditions":["Stroke, Lacunar","Stroke, Acute Ischemic","Cerebral Small Vessel Diseases"],"enrollment":3156,"completionDate":"2028-02-29"},{"nctId":"NCT06472921","phase":"PHASE2","title":"Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.","status":"COMPLETED","sponsor":"Xiangya Hospital of Central South University","startDate":"2024-07-29","conditions":["Acute Ischemic Stroke"],"enrollment":204,"completionDate":"2025-11-20"},{"nctId":"NCT07230587","phase":"PHASE3","title":"Butylphthalide for Long-term Efficacy in Minor Stroke Study","status":"NOT_YET_RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2025-12-01","conditions":["Ischemic Stroke","Minor Stroke"],"enrollment":1200,"completionDate":"2028-10-01"},{"nctId":"NCT07193277","phase":"PHASE4","title":"Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy","status":"RECRUITING","sponsor":"First Affiliated Hospital of Wenzhou Medical University","startDate":"2025-09-01","conditions":["Focal Epilepsy","Cognitive Impairment"],"enrollment":220,"completionDate":"2028-09-01"},{"nctId":"NCT07138014","phase":"PHASE2","title":"FHND1002 for ALS Treatment: Phase 2","status":"NOT_YET_RECRUITING","sponsor":"Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.","startDate":"2025-10-01","conditions":["Amyotrophic Lateral Sclerosis (ALS)"],"enrollment":180,"completionDate":"2028-03-01"},{"nctId":"NCT04664933","phase":"NA","title":"Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)","status":"RECRUITING","sponsor":"Hui-Sheng Chen","startDate":"2020-12-01","conditions":["Stroke, Ischemic","Intravascular Thrombosis","Mechanical Thrombectomy"],"enrollment":30,"completionDate":"2026-05-31"},{"nctId":"NCT04664946","phase":"NA","title":"Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)","status":"RECRUITING","sponsor":"Hui-Sheng Chen","startDate":"2020-12-01","conditions":["Ischemic Stroke","Neuroprotection"],"enrollment":30,"completionDate":"2026-05-01"},{"nctId":"NCT06572085","phase":"PHASE4","title":"Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients","status":"RECRUITING","sponsor":"Tang Ziren","startDate":"2022-01-01","conditions":["Butylphthalide","Cardiac Arrest","Neuroprotective Drugs"],"enrollment":350,"completionDate":"2027-12-31"},{"nctId":"NCT06353334","phase":"PHASE4","title":"Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)","status":"RECRUITING","sponsor":"Tang Ziren","startDate":"2021-09-01","conditions":["Butylphthalide","Cardiac Arrest","Neuroprotective Drugs"],"enrollment":100,"completionDate":"2026-12-31"},{"nctId":"NCT06704685","phase":"PHASE3","title":"A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI","status":"NOT_YET_RECRUITING","sponsor":"Xiangya Hospital of Central South University","startDate":"2024-12-01","conditions":["ST-segment Elevation Myocardial Infarction (STEMI)"],"enrollment":40,"completionDate":"2025-12-31"},{"nctId":"NCT06508671","phase":"PHASE4","title":"Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment","status":"NOT_YET_RECRUITING","sponsor":"First Hospital of China Medical University","startDate":"2024-07","conditions":["Chemotherapy-Related Cognitive Impairment","DL-3-n-butylphthalide"],"enrollment":100,"completionDate":"2026-12"},{"nctId":"NCT05976152","phase":"PHASE3","title":"Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)","status":"RECRUITING","sponsor":"Fudan University","startDate":"2024-04","conditions":["Stroke","Post-stroke Cognitive Impairment (PSCI)"],"enrollment":3200,"completionDate":"2026-12"},{"nctId":"NCT05068349","phase":"PHASE4","title":"For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.","status":"RECRUITING","sponsor":"Qianfoshan Hospital","startDate":"2022-05-07","conditions":["Stroke","Cerebral Infarction","Brain Infarction","Brain Ischemia","Nervous System Diseases","Central Nervous System Diseases","Vascular Diseases"],"enrollment":300,"completionDate":"2025-12"},{"nctId":"NCT05086874","phase":"","title":"Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients","status":"COMPLETED","sponsor":"Xin Huang","startDate":"2022-05-07","conditions":["Stroke","Cerebral Infarction","Brain Infarction","Brain Ischemia","Nervous System Diseases","Central Nervous System Diseases","Vascular Diseases","Cardiovascular Diseases"],"enrollment":81292,"completionDate":"2023-03-01"},{"nctId":"NCT06331494","phase":"NA","title":"Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital, Sun Yat-Sen University","startDate":"2024-03-15","conditions":["Ischemic Stroke, Acute","Intracranial Atherosclerosis"],"enrollment":140,"completionDate":"2026-08-31"},{"nctId":"NCT05920902","phase":"","title":"Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)","status":"UNKNOWN","sponsor":"Ruijin Hospital","startDate":"2021-10-01","conditions":["Acute Ischemic Stroke"],"enrollment":200,"completionDate":"2024-12-31"},{"nctId":"NCT04675450","phase":"PHASE2","title":"NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy","status":"WITHDRAWN","sponsor":"Conjupro Biotherapeutics, Inc.","startDate":"2023-06-30","conditions":["Breast Cancer","Peripheral Neuropathy"],"enrollment":0,"completionDate":"2025-01-30"},{"nctId":"NCT03539445","phase":"PHASE3","title":"Efficacy and Safety of Butylphthalide for Acute Ischemic Stroke Patients Receiving Intravenous Thrombolysis or Endovascular Treatment","status":"COMPLETED","sponsor":"Beijing Tiantan Hospital","startDate":"2018-07-01","conditions":["Acute Ischemic Stroke"],"enrollment":1216,"completionDate":"2022-07-31"},{"nctId":"NCT03413202","phase":"PHASE4","title":"Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Acute Ischemic Stroke.","status":"COMPLETED","sponsor":"Yi Yang","startDate":"2018-02-28","conditions":["Acute Ischemic Stroke"],"enrollment":99,"completionDate":"2022-05-25"},{"nctId":"NCT02905565","phase":"PHASE2","title":"NBP in Adult Patients With Acute Ischemic Stroke (AIS)","status":"COMPLETED","sponsor":"CSPC-NBP Pharmaceutical Co., Ltd.","startDate":"2018-02-28","conditions":["AIS"],"enrollment":177,"completionDate":"2020-08-07"},{"nctId":"NCT02149875","phase":"PHASE1,PHASE2","title":"Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke","status":"COMPLETED","sponsor":"Shanghai 6th People's Hospital","startDate":"2010-01","conditions":["Acute Cerebral Stroke Within 12 Hours for the First Time"],"enrollment":84,"completionDate":"2010-05"},{"nctId":"NCT02711683","phase":"","title":"DL-3-n-butylphthalide Treatment in Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil","status":"COMPLETED","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2016-03","conditions":["Alzheimer's Disease"],"enrollment":92,"completionDate":"2019-12"},{"nctId":"NCT04205578","phase":"PHASE3","title":"NBP in Patients With Moyamoya Disease of High Risk for Ischemic Cerebrovascular Events","status":"UNKNOWN","sponsor":"yuanli Zhao","startDate":"2020-01","conditions":["Moyamoya Disease","Ischemic Cerebral Infarction","Ischemic Stroke","Ischemic Cerebrovascular Accident","Transient Ischemic Attack"],"enrollment":450,"completionDate":"2022-12-31"},{"nctId":"NCT04091412","phase":"PHASE4","title":"Study of Collateral Circulation in Patients With Symptomatic Intracranial Anterior Circulation Occlusion","status":"UNKNOWN","sponsor":"The Second Hospital of Hebei Medical University","startDate":"2019-05-05","conditions":["Collateral Circulation","Large-artery Occlusion","Cerebral Infarction"],"enrollment":500,"completionDate":"2020-05-01"},{"nctId":"NCT04078204","phase":"NA","title":"A Clinical Study on the Treatment of Cerebral Small Vascular Disease","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2018-04-25","conditions":["Cerebral Small Vessel Diseases"],"enrollment":300,"completionDate":"2022-06"},{"nctId":"NCT03906123","phase":"NA","title":"The Efficacy of DL-NBP in Patients With Mild Subcortical Ischemic Vascular Dementia","status":"UNKNOWN","sponsor":"Tianjin Medical University General Hospital","startDate":"2017-11-18","conditions":["Subcortical Vascular Dementia","Cerebral Small Vessel Diseases"],"enrollment":64,"completionDate":"2020-01-31"},{"nctId":"NCT02993367","phase":"PHASE2,PHASE3","title":"The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND","status":"UNKNOWN","sponsor":"The Second Hospital of Hebei Medical University","startDate":"2017-01","conditions":["Vascular Cognitive Impairment no Dementia"],"enrollment":200,"completionDate":"2019-07"},{"nctId":"NCT01405248","phase":"PHASE3","title":"Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting","status":"COMPLETED","sponsor":"Jinling Hospital, China","startDate":"2011-07","conditions":["Restenosis"],"enrollment":100,"completionDate":"2014-01"},{"nctId":"NCT01556854","phase":"","title":"Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke","status":"UNKNOWN","sponsor":"yongjun wang","startDate":"2011-07","conditions":["Acute Ischemic Stroke"],"enrollment":20000,"completionDate":"2014-06"},{"nctId":"NCT00724724","phase":"PHASE4","title":"The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2008-08","conditions":["Stroke","Transient Ischemic Attack"],"enrollment":1000,"completionDate":"2011-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"822Q956KGM","INN_ID":"9914","RXNORM":"1484499","UMLSCUI":"C0047625","chemblId":"CHEMBL248594","ChEMBL_ID":"CHEMBL248594","DRUGBANK_ID":"DB12749","PUBCHEM_CID":"61361"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"CSPC Ouyi Pharmaceutical","relationship":"Current Owner"}],"publicationCount":753,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"CSPC Ouyi Pharmaceutical","companyId":"cspc-ouyi-pharmaceutical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"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":14,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:23:29.111854+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}