Cerebrolysin
Cerebrolysin (standardized porcine brain-derived peptide/amino-acid mixture)
Evidence & Status
- Moderate Evidence
- Moderate
At a Glance
A standardized porcine brain-derived peptide/amino-acid mixture, not a single molecular entity. Clinical benefit is mixed and uncertain; evidence must remain condition-, population-, endpoint-, and product-specific.
Plain English
Researchers study Cerebrolysin as a heterogeneous porcine brain-derived mixture. Its stroke evidence is low- or very-low-certainty and does not reliably show improved functional independence; TBI findings are population- and endpoint-specific. It is not FDA-approved.
Overview
Cerebrolysin is a heterogeneous porcine-brain-derived peptide mixture, not a single molecular entity. The approved evidence set includes a stroke systematic review and randomized trials in traumatic brain injury; results should be interpreted by condition, study design, and formulation, not as proof of a uniform neurotrophic mechanism or a general treatment regimen.
Research Summary
Stroke evidence is low- or very-low-certainty and does not reliably demonstrate improved functional independence. TBI findings remain population- and endpoint-specific. These sources do not support transferring claims across stroke, dementia, and traumatic brain injury or treating the mixture as a defined single peptide.
Research Areas
- Ischemic stroke recovery
- Alzheimer's disease
- Vascular dementia
- TBI rehabilitation
- Neuroprotection
Legal Status by Region
- United States
- Not FDA-approved. Any non-U.S. authorization claim must identify the product, country, formulation, and indication from an official source.
- United Kingdom
- Not FDA-approved. Any non-U.S. authorization claim must identify the product, country, formulation, and indication from an official source.
- Australia
- Not FDA-approved. Any non-U.S. authorization claim must identify the product, country, formulation, and indication from an official source.
- Canada
- Not FDA-approved. Any non-U.S. authorization claim must identify the product, country, formulation, and indication from an official source.
Citations & Sources
- Cerebrolysin for acute ischaemic stroke.
Ziganshina LE et al. · Cochrane Database of Systematic Reviews · 2023
PMID 37818733 · DOI 10.1002/14651858.CD007026.pub7
- Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial.
Muresanu DF et al. · Neurological Sciences · 2020
PMID 31897941 · DOI 10.1007/s10072-019-04181-y
- Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.
Poon W et al. · Neurological Sciences · 2020
PMID 31494820 · DOI 10.1007/s10072-019-04053-5