Overview
Butylphthalide has been used in trials studying the prevention of Restenosis.
Indication
⑴用于治疗轻、中度急性缺血性脑卒中及急性缺血性脑卒中患者神经功能缺损的改善。 ⑵用于非痴呆型血管性认知障碍【美国FDA未批准;《中国痴呆与认知障碍诊治指南2015》;中国卒中学会《卒中后认知障碍管理专家共识2017》】。
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Monograph on Butylphthalide (DB12749): From Celery Seed to Neuroprotective Agent
I. Executive Summary
Butylphthalide, also known by the abbreviation NBP, is a small molecule compound with the DrugBank accession number DB12749. Originally identified and isolated from the seeds of celery (Apium graveolens), it has been synthetically developed into a significant therapeutic agent, particularly in the field of neuropharmacology.[1] This report provides an exhaustive analysis of its chemical properties, complex pharmacology, clinical applications, safety profile, and global regulatory status.
The pharmacological profile of Butylphthalide is uniquely characterized by its pleiotropic, multi-target mechanism of action. Unlike many pharmaceuticals that act on a single receptor or enzyme, Butylphthalide exerts its neuroprotective effects by concurrently modulating several key pathophysiological pathways implicated in ischemic and neurodegenerative damage. Its core mechanisms include the reconstruction of cerebral microcirculation, protection of mitochondrial function against ischemic stress, and potent anti-inflammatory, antioxidant, and anti-apoptotic activities.[4] This multifaceted approach is believed to be central to its clinical efficacy in complex neurological disorders.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/25 | Not Applicable | Recruiting | |||
2024/11/26 | Phase 3 | Not yet recruiting | Xiangya Hospital of Central South University | ||
2024/08/26 | Phase 4 | Recruiting | Tang Ziren | ||
2024/07/18 | Phase 4 | Not yet recruiting | First Hospital of China Medical University | ||
2024/04/09 | Phase 4 | Recruiting | Tang Ziren | ||
2024/03/26 | Not Applicable | Not yet recruiting | First Affiliated Hospital, Sun Yat-Sen University | ||
2021/10/05 | Phase 4 | Recruiting | Qianfoshan Hospital | ||
2019/12/19 | Phase 3 | UNKNOWN | yuanli Zhao | ||
2019/09/16 | Phase 4 | UNKNOWN | |||
2019/09/04 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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