Drug intelligence / Profile preview

butylphthalide + tenecteplase

Development stage
Unknown
Lead developer
CSPC Pharmaceutical Group
Modality
Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous, Oral
01

Overview

butylphthalide + tenecteplase is a combination therapeutic regimen being investigated for the treatment of mild disabling acute ischemic stroke (AIS). This combination therapy is the focus of the Phase 3 BENEFIT-2 trial, led by Xiangya Hospital of Central South University. Butylphthalide (NBP) is a multi-targeted neuroprotective small molecule, originally extracted from seeds of *Apium graveolens* (Chinese celery) and approved in China since 2002. It works through multiple mechanisms including reconstructing microcirculation, protecting mitochondrial function, and inhibiting neuronal apoptosis. Tenecteplase (TNK) is a recombinant, fibrin-specific plasminogen activator used as a thrombolytic agent to dissolve blood clots by converting plasminogen to plasmin. The BENEFIT-2 trial evaluates the synergistic 'vascular recanalization + neuroprotection' effect of adding sequential intravenous and oral butylphthalide to tenecteplase thrombolysis in patients with mild disabling AIS within 4.5 hours of symptom onset, aiming to improve functional recovery as measured by the modified Rankin Scale (mRS).

Brand names
Enbipu
Other names
DL-3-n-butylphthalideDL3-n-butylphthalideDL 3-n-butylphthalide3-N-butylphthalideBENEFIT-2BENEFIT2BENEFIT 2
02

Targets

PLG (Plasminogen)Fibrin (Factor Ia)

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