Drugs / Butylphthalide
Butylphthalide
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02149875 | Jan → May 2010 | cerebral artery occlusion | Shanghai 6th People's Hospital | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07518810 | Apr 2026 → Apr 2027 expected | multiple system atrophy | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT02993367 | Jan 2017 → Jan 2019 | cognitive impairment with or without cerebellar ataxia | The Second Hospital of Hebei Medical University | Unknown | Met primary |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT07369999 | Feb 2026 → Mar 2029 expected | stroke disorder | Xiangya Hospital of Central South University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07230587 | Dec 2025 → Sep 2027 expected | ischemic stroke | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07252544 | Dec 2025 → Aug 2027 expected | ischemic stroke | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06704685 | Dec 2024 → Oct 2025 overdue | ST-elevation myocardial infarction | Xiangya Hospital of Central South University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03804229 | Oct 2019 → Oct 2024 overdue | vascular dementia | Capital Medical University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03539445 | Jul 2018 → May 2022 | ischemic stroke | Beijing Tiantan Hospital | Completed | Met primary |
| Phase 3 | NCT01405248 | Jul 2011 → Jan 2014 | coronary restenosis | Jinling Hospital, China | Completed | No outcome recorded |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT07528456 | Apr 2026 → Apr 2027 expected | ischemic stroke | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07193277 | Sep 2025 → Dec 2027 expected | cognitive impairment with or without cerebellar ataxia, focal epilepsy | First Affiliated Hospital of Wenzhou Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT06508671 | Jul 2024 → Dec 2025 overdue | chemotherapy-induced toxicity | First Hospital of China Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05068349 | May 2022 → Sep 2025 | brain ischemia, cerebral infarction | Qianfoshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06572085 | Jan 2022 → Dec 2027 expected | cardiac arrest | Tang Ziren | Recruiting | No outcome recorded |
| Phase 4 | NCT06353334 | Sep 2021 → Dec 2026 expected | cardiac arrest | Tang Ziren | Recruiting | No outcome recorded |
| Phase 4 | NCT04091412 | May 2019 → Jan 2020 | cerebral infarction, vascular occlusion disorder | The Second Hospital of Hebei Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03413202 | Feb 2018 → Mar 2022 | ischemic stroke | Yi Yang | Completed | Met primary |
| Phase 4 | NCT02594995 | Jul 2015 → Sep 2016 | anterior cerebral artery infarction, cerebral artery occlusion | Second Affiliated Hospital, School of Medicine, Zhejiang University | Completed | No outcome recorded |
| Phase 4 | NCT00724724 | Aug 2008 → Jun 2011 | transient ischemic attack | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT06968429 | May 2025 → Dec 2027 expected | migraine disorder | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06331494 | Mar 2024 → May 2026 overdue | cerebral atherosclerosis, ischemic stroke | First Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| — | NCT04664946 | Dec 2020 → May 2028 expected | ischemic stroke | Huisheng Chen | Recruiting | No outcome recorded |
| — | NCT04664933 | Dec 2020 → May 2028 expected | ischemic stroke, thrombotic disease | Huisheng Chen | Recruiting | No outcome recorded |
| — | NCT04078204 | Apr 2018 → Feb 2022 | cerebrovascular disorder | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT03906123 | Nov 2017 → Dec 2019 | vascular dementia | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04205578 Comparator | Jan 2020 → Dec 2022 | Moyamoya disease, cerebral infarction, transient ischemic attack | yuanli Zhao | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-12-28 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory INSIDE INFORMATION - ADJUSTMENT TO THE MEDICAL INSURANCE REIMBURSEMENT BASIS irasia.com ↗
the new reimbursement basis for Butylphthalide Soft Capsule and Butylphthalide and Sodium Chloride Injection will be RMB3.36 per capsule and RMB139 per injection respectively |
| 2018-03-11 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - THE GROUP'S DRUG "BUTYLPHTHALIDE" WAS GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
| 2016-04-20 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - THE GROUP'S CHEMICAL DRUG "BUTYLPHTHALIDE SOFT CAPSULES" WAS GRANTED CLINICAL TRIAL APPROVAL IN RELATION TO A NEW INDICATION FOR VASCULAR DEMENTIA irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries (the “ Group”)) is pleased to announce that the pre-clinical trial data of the Group’s chemical drug “ butylphthalide soft capsules” (the “ Product ”) in relation to the new indication for the treatment of vascular dementia caused by ischemic stroke (“ Vascular Dementia ”) has passed the technical assessment of the Centre for Drug Evaluation of China Food and Drug Administration (the “CFDA”) of the People’s Republic of China (“China”), and was recently granted clinical trial approval from the CFDA. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-12-28 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | INSIDE INFORMATION - ADJUSTMENT TO THE MEDICAL INSURANCE REIMBURSEMENT BASIS irasia.com ↗ |
| 2018-03-11 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - THE GROUP'S DRUG "BUTYLPHTHALIDE" WAS GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
| 2016-04-20 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - THE GROUP'S CHEMICAL DRUG "BUTYLPHTHALIDE SOFT CAPSULES" WAS GRANTED CLINICAL TRIAL APPROVAL IN RELATION TO A NEW INDICATION FOR VASCULAR DEMENTIA irasia.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | butylphthalide | “Tenecteplase (TNK), a novel thrombolytic agent with favorable pharmacokinetic profiles, and butylphthalide (NBP), a multi-targeted neuroprotective drug, have shown promising...” NCT07369999 ↗18“oral butylphthalide soft capsules for the prophylactic treatment of migraine in adults” NCT06968429 ↗ “Take 200 mg butylphthalide soft capsules (NBP) orally three times a day for 24 weeks” NCT06508671 ↗ |
| Known as | 3-N-butylphthalide | “Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min” NCT04664933 ↗2“Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.” NCT04664946 ↗ |
| Known as | Butylphthalide and Sodium Chloride Injection | “For patients in the butylphthalide group, Butylphthalide and Sodium Chloride Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice...” NCT07528456 ↗ |
| Known as | Butylphthalide Soft Capsules, En Bi Pu (NBP) | “Butylphthalide Soft Capsules, En Bi Pu (NBP)” NCT00724724 ↗ |
| Known as | celery seed oil extract | “3-n-Butylphthalide (NBP), also known as celery seed oil extract, is a lipid-soluble compound isolated from celery seeds.” NCT07518810 ↗ |
| Known as | Dl-3-n-butylphthalide | “Butylphthalide, as a well-known neuroprotective medication, is a family of compounds initially isolated from the seeds of Apium graveolens Linn, of which active ingredient is...” NCT03539445 ↗6“DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.” NCT02993367 ↗ “Dl-3-n-butylphthalide (NBP), isolated from the seeds of celery” NCT02594995 ↗ “DL-3-n-butylphthalide” NCT03906123 ↗ |
| Known as | NBP | “Our preliminary single-center study suggests that postoperative intravenous administration of dl-3-n-butylphthalide (NBP) may alleviate perioperative neurological deficits and...” NCT04205578 ↗10“Tenecteplase (TNK), a novel thrombolytic agent with favorable pharmacokinetic profiles, and butylphthalide (NBP), a multi-targeted neuroprotective drug, have shown promising...” NCT07369999 ↗ “This study is designed to evaluate the safety and efficacy of butylphthalide (NBP) in the treatment of cerebral small vessel disease through a multicenter,...” NCT04078204 ↗ “Cerebrolysin and DL-3-n-butylphthalide (NBP) have each shown neuroprotective efficacy in preclinical models of acute ischemic stroke (AIS) and passed clinical trials as...” PMID 27168844 ↗ Mar 2016 “Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain.” NCT06353334 ↗ “3-n-Butylphthalide (NBP), also known as celery seed oil extract, is a lipid-soluble compound isolated from celery seeds.” NCT07518810 ↗ “DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.” NCT02993367 ↗ “Take 200 mg butylphthalide soft capsules (NBP) orally three times a day for 24 weeks” NCT06508671 ↗ “25mg butylphthalide(NBP) injection, and 100ml 0.9% saline” NCT03413202 ↗ |
| Modality | Small molecule | “DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.” NCT02993367 ↗ |
| Route | Oral | “20 mg/time per os three times a day.” NCT01405248 ↗ |