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Cerebrolysin Clinical Trials 2026: Type Comparison

Ischemic Stroke (Phase III) n=600, MCA territory infarct, mRS 3–4 at baseline, <24h from onset Functional independence at 90 days (mRS ≤2) 10ml IV daily × 21 days First trial powered for mRS as primary endpoint with standardized time-to-treatment stratificatio

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  • Ischemic Stroke (Phase III)
  • n=600, MCA territory infarct, mRS 3–4 at baseline, <24h from onset
  • Functional independence at 90 days (mRS ≤2)
  • 10ml IV daily × 21 days
  • First trial powered for mRS as primary endpoint with standardized time-to-treatment stratification
  • Largest and most rigorous stroke trial to date. Success here drives regulatory approval
  • Traumatic Brain Injury (Phase III)
  • n=400, GCS 6–12, diffuse axonal injury or contusion on MRI
  • Glasgow Outcome Scale-Extended (GOSE) at 180 days
  • First TBI trial to use volumetric MRI and plasma biomarkers as prespecified secondary endpoints
  • If successful, first pharmacologic TBI treatment ever approved
  • Vascular Dementia (Phase II/III)
  • n=200, CDR 1–2, white matter hyperintensities on MRI
  • ADAS-Cog change from baseline at 52 weeks
  • 10ml IV daily × 21 days, repeated quarterly
  • Only trial testing Cerebrolysin in chronic neurodegenerative disease rather than acute injury
  • Exploratory but addresses massive unmet need with no existing treatment options
  • The stroke and TBI trials are fully powered for their primary endpoints with 90% statistical power to detect a 15% absolute difference in functional independence rates. The vascular dementia trial is smaller and considered hypothesis-generating, but positive results would justify a larger Phase III follow-on. All three trials share identical safety monitoring (liver function tests, renal function, coagulation parameters at baseline, day 21, and final follow-up) and use the same investigational product manufactured by EVER Neuro Pharma under EU GMP standards.

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