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.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | |||
2019/01/15 | Phase 3 | Active, not recruiting | Capital Medical University |
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 |
|---|---|---|---|---|---|
| Butylphthalide and Sodium Chloride Injection | 国药准字H20100041 | 化学药品 | 注射剂 | 1/8/2020 | |
| Butylphthalide Soft Capsules | 国药准字H20050299 | 化学药品 | 胶囊剂 | 3/27/2020 |
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. | |||||
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