MedPath

Butylphthalide

Generic Name
Butylphthalide
Drug Type
Small Molecule
Chemical Formula
C12H14O2
CAS Number
6066-49-5
Unique Ingredient Identifier
822Q956KGM

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

Published: Sep 23, 2025

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.

Continue reading the full research report

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.