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Butylphthalide soft capsule
Butylphthalide soft capsule is a Neuroprotective agent Small molecule drug developed by Capital Medical University. It is currently in Phase 3 development for Acute ischemic stroke, Post-stroke neurological recovery. Also known as: The effects of Butylphthalide soft capsule on VaD.
Butylphthalide protects brain cells by improving mitochondrial function and reducing oxidative stress and inflammation following ischemic stroke.
Butylphthalide is a small molecule used in clinical trials to study its effects on various conditions, including stroke and cerebral small vessel diseases. It has been studied in combination with isosorbide mononitrate in trials such as "Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke".
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Butylphthalide soft capsule |
|---|---|
| Also known as | The effects of Butylphthalide soft capsule on VaD |
| Sponsor | Capital Medical University |
| Drug class | Neuroprotective agent |
| Target | Mitochondrial function modulator (non-specific) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Butylphthalide is a neuroprotective agent that works primarily through mitochondrial stabilization, enhancing cellular energy production and reducing reactive oxygen species generation. It also modulates inflammatory pathways and apoptosis, thereby limiting neuronal damage in acute ischemic stroke and promoting recovery of neurological function.
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 capsule CI brief — competitive landscape report
- Butylphthalide soft capsule updates RSS · CI watch RSS
- Capital Medical University portfolio CI
Frequently asked questions about Butylphthalide soft capsule
What is Butylphthalide soft capsule?
How does Butylphthalide soft capsule work?
What is Butylphthalide soft capsule used for?
Who makes Butylphthalide soft capsule?
Is Butylphthalide soft capsule also known as anything else?
What drug class is Butylphthalide soft capsule in?
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What does Butylphthalide soft capsule target?
Related
- Drug class: All Neuroprotective agent drugs
- Target: All drugs targeting Mitochondrial function modulator (non-specific)
- Manufacturer: Capital Medical University — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Acute ischemic stroke
- Indication: Drugs for Post-stroke neurological recovery
- Also known as: The effects of Butylphthalide soft capsule on VaD
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing