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Butylphthalide Soft Capsules
Butylphthalide protects brain cells by improving mitochondrial function and reducing oxidative stress and inflammation following ischemic stroke.
Butylphthalide protects brain cells by improving mitochondrial function and reducing oxidative stress and inflammation following ischemic stroke. Used for Acute ischemic stroke, Post-stroke neurological recovery.
At a glance
| Generic name | Butylphthalide Soft Capsules |
|---|---|
| Also known as | Butylphthalide Soft Capsules, En Bi Pu (NBP), NBP |
| Sponsor | Peking Union Medical College Hospital |
| Drug class | Neuroprotective agent |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Butylphthalide is a neuroprotective agent that works primarily by enhancing mitochondrial ATP production and reducing free radical-induced cellular damage. It decreases inflammatory cytokine release and apoptosis in ischemic brain tissue, thereby limiting the extent of neuronal death and promoting recovery of neurological function after acute ischemic stroke.
Approved indications
- Acute ischemic stroke
- Post-stroke neurological recovery
Common side effects
- Gastrointestinal disturbance
- Dizziness
- Headache
Key clinical trials
- Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia (PHASE3)
- Effects of Butylphthalide Enhanced With Tenecteplase on Neurological Function in Mild Disabling Acute Ischemic Stroke (PHASE3)
- Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT) (PHASE3)
- Butylphthalide for Long-term Efficacy in Minor Stroke Study (PHASE3)
- Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy (PHASE4)
- 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 (PHASE3)
- Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment (PHASE4)
- Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Butylphthalide Soft Capsules CI brief — competitive landscape report
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- Peking Union Medical College Hospital portfolio CI